dispatch and import - export

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Dispatch & Import -Export-A summer internship report (June-July 2011)

Guided By: Mr. Jigneshkumar Soni

Prepared By: Nikul G Moradiya (10066)

Master of Business Administration

2010 12

Submitted To: G H Patel P G Institute of BusinessManagement

Unimed Technologies Limited

9/7/2011


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I. PREFACE

Pharmaceutical industry is one of the highest growing industries in India and this report

presents a live picture of one such leading organization in the same industry: UnimedTechnology Limited. This report is divided in two parts.

Part:-1 It introduces all the departments of the organization and their functions.

Basically it is just an overview with enough details so that any person, reading this report

might fill him/herself acquainted of the pharma industry. There are many jargons and

technical details used in this report because to know about the pharma company, any

person (either science or non science background) must go through at least this much of

details.

Part:-2 this part presents the core subject of my summer internship. Here the complete

process and all possible details of IMPORT EXPORT and DISPATCH are given.

Reader may find a bit typical law language in this part. I have tried my best to translate

this language in simple form without omitting important details and modification of

meanings. Almost all the laws and change in rules related to import export has been

covered.

Documentation is the most important part of importexport process. This report covers

detailed information about the all required documents and possible samples of documents

are also attached.


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II. ACKNOWLEDGEMENT

I would like to thank our director Dr. H J Jani who has given me such a great opportunity

to interact myself with the industry. I would also like to thank all other faculty members

of GHPIBM who directly or indirectly helped me in completion of my summer internship

project.

I have taken efforts in this project. However, it would not have been possible without the

kind support and help of many individuals of Unimed Technologies Limited. I would

like to extend my sincere thanks to all of them.

I am highly indebted to Mr. JIGNESHKUMAR SONI, Head; BSR/UTL for their

guidance and constant supervision as well as for providing necessary information

regarding the project & also for their support in completing the project.

I would like to express my gratitude towards

Mr. Pushpendrakumar Jain General Manager, Operations

Mr. Ajit Thakor Head, Personnel and Administration

Mr. Jagat unadkat Assistant manager, production

Mr. Bhagvan Nehate Head, production

Mr. Rameshchandra Joshi Assistant manager, engineering

Mr. Ashim Tendulkar Head, Engineering

Mr. Nilesh Bhatt Head, Quality Assurance

Mr. Vijay Kashyap Head, Quality Control

Mr. Sameer Shah Assistant manager, Store

For their kind co-operation and encouragement which help me in completion of this

project. I would like to express my gratitude and thanks to all of them for giving me such

attention and time.


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INDEX

Page No.

Preface 2Acknowledgement 3

Part I

An overview of Indian pharma industry 5

Personnel & Administration department 9

Engineering department 14

Production department 20

Packaging department 27

Quality Assurance & Quality Control department 29

Part II

Warehouse department 36

Dispatch 41

Import 45

Export 50

Attachments 69


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An Overview of Indian Pharma industry

The Indian Pharmaceutical Industrytoday is in the front rank of Indias science-based

industries with wide ranging capabilities in the complex field of drug manufacture and

technology.

Playing a key role in promoting and sustaining development in the vital field of medicines,

Indian Pharma Industry boasts of quality producers with many units approved by regulatory

authorities in USA and UK.

Indian pharma

Domestic Market: US $ 7bn Export: US $ 5bn Total: US $ 12-13bn

Contract manufacturing

-JV/Alliance

-com etition from China

Generic business

-Increasing competition

-Prising pressure

-Acquisition

-a ressive build u of roducts

Domestic formulation

-IPR regime

-pricing pressure on old

molecules

-brands differianted products

-ANDA/NDDS/NEC

-Out Licensing

-High Investment / Long

Gestation


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Indian pharma sector: Growth Scenario in 2010

Third in the world in terms of volume.Rank is 14th in terms of value.The domestic market was worth US$ 12.26 billion.Market reached US$ 10.04 billion in size in July 2010.

The Indian Pharma Industry is estimated to be worth $ 4.5 billionGrowing at about 8 to 9 percent annually.

KEY OPPORTUNITY SEGMENTS

Leading Pharmaceutical Companies

Indian

pharmaceutical

industry

Manufacturing

opportunities

Contract

research

Innovation

opportunities

Manufacturing

opportunities


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In the domestic market, Cipla retained its leadership position with 5.27 per cent share. Ranbaxy

followed next. The highest growth was for Mankind Pharma (37.2%). Other leading companies

in the Indian pharma market in 2010 are

Sun Pharma (25.7%)

Abbott (25%)

Zydus Cadila (24.1%)

Alkem Laboratories (23.3%)

Pfizer (23.6 %)

GSK India (19%)

Piramal Healthcare (18.6 %)

Lupin (18.8 %)

The Indian pharmaceuticals market is expected to reach US$ 55 billion in 2020 from US$ 12.6

billion in 2009. This was stated in a report title "India Pharma 2020: Propelling access and

acceptance, realising true potential" by McKinsey & Company. In the same report, it was also

mentioned that in an aggressive growth scenario, the pharma market has the further potential to

reach US$ 70 billion by 2020

Due to increase in the population of high income group, there is every likelihood that they will

open a potential US$ 8 billion market for multinational companies selling costly drugs by 2015.

This was estimated in a report by Ernst & Young. The domestic pharma market is estimated to

touch US$ 20 billion by 2015. The healthcare market in India to reach US$ 31.59 billion by

2020. The sale of all types ofpharmaceutical drugs and medicines in the country stands at US$

9.61 billion, which is expected to reach around US$ 19.22 billion by 2012. Thus India would

really become a lucrative destination for clinical trials for global giants.
http://www.pharmaceutical-drug-manufacturers.com/pharmaceutical-drugs/http://www.pharmaceutical-drug-manufacturers.com/pharmaceutical-drugs/


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Unimed Technologies Limited

Unimed has been established in the year 1990. Companys production plant is situated above 36

Km east from VADODARA & 6 km away from HALOL. Unimed is one of the leading

companies, having an asset of its quality products. Unimed works under loan license of SUN

pharma. Unimed is producing Parenteral, Ophthalmic and Hormone products. Currently

company is producing more than 100 products.

Few well known Unimed products are

Cardiject injection

Careprost

DepopredEyemist

Fertigyn

Ivepred

Letoprost

Lupride depot

Ocepred, etc.

Unimed is also preparing to launch its new plant for production of ANDA Abbreviated New

Drug Application. This plant is constructed according to US FDA guidelines.

UTL has also constructed a gas based power plant to become self-reliable.


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1. Personnel & administration

The meaning of HR is Human Resource but at the Unimed its also stands forHappy Relations.

The human resource department of the company deals with employment, recruitment and

placement. It also takes care of employer-employee relations, compensation benefits and training

& development.

The role of HR is not only managing the human resource but also it is a strategic business

contributor. It is not worthless to say that HR provides the support to management in

accomplishing the original objectives. Intellectual management or human resource management

in this transition phase is handling by HR.

ORGANOGRAM OF UNIMED TECHNOLOGIES LIMITEDLIMITED

Part - I


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HOD of each department is supported by cluster of subordinates and we can present them in

form of hierarchical chart as per below..

This kind of organized structure of manpower always produces the desired results and pushingforwards the organization towards the achievement of objectives.


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1.1. Recruitment process

There are ten ways for not to do the work, but there is only one way to do the work. Probably

this saying is worth for any employee in any organization. The recruitment and selection is the

major function of the human resource department and recruitment process is the first step

towards creating the competitive strength and the strategic advantage for the organizations.

Recruitment process involves a systematic procedure from sourcing the candidate to arranging

and conducting the interviews and requires many resources and time.

At the Unimed recruitment process is conducted by the very experienced team of HR specialists

and professionals from other departments. The whole process can be described in few simple

steps.


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1.2. Training process

a. Induction

b. General QA system training

c. Departmental SOP training

d. On Job Training

e. GMP

f. Evaluation

g. Qualification and approval

Identify vacancy

Jo b description and job specification

Search resume relevant to job

Scrutinization of resume

Arrange interviews

Conduct interviews

Final selection

Appointment process


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1.3. Appraisal

People differ in their abilities and their aptitudes. There is always some difference between the

quality and quantity of the same work on the same job being done by two different people.

Performance appraisals of Employees are necessary to understand each employees abilities,

competencies and relative merit and worth for the organization. Performance appraisalrates the

employees in terms of their performance.

Performance appraisals are widely used in the society. An employer evaluating their employees

is a very old concept. Performance appraisals are an indispensable part of performance

measurement.

The latest mantra being followed by organizations across the world being "get paid according to what

you contribute" the focus of the organizations is turning to performance management and specifically

to individual performance. Performance appraisal helps to rate the performance of the employees and

evaluate their contribution towards the organizational goals.

Performance appraisal takes into account the past performance of the employees and focuses on

the improvement of the future performance of the employees.

1.4. Motivation

En employee can be compared with the milking cow. If they would be taken care of

(economically and emotionally) then they will produce the best outcome.

At the Unimed employees are being awarded regular increments as well as promotions to

superior designation as per their work experience and commitment towards the organization.

Apart from money factor, employees are regularly undergoes to medical checkup which shows

commitment of organization towards the employees. Employees are also having enough sick

leaves, paid leaves and casual leaves which transforms into a unique working experience without

disturbing social life of individual.


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2. Engineering

WFI

RO

PW

GEB supply

Generator


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2.1. Water supply

The natural water contains solid, liquid and gaseous impurities and therefore, this water cannot

be used in process. The impurities present in the water cannot be removed before its use. The

necessity for reducing the corrosive nature & quantity of dissolved and suspended solid s in the

feed water has become increasingly important with advent of utilities or process application.

2.1.1.Impurities in water:

The impurities present in the feed water are classified as given below,

Turbidity & sediments calcium salt free mineral acid CO2

Sodium and potassium salts magnesium salt oil O2ChlorideIronManganeseSilicaMicrobiological growthColor

2.1.2.Reverse osmosis process

The reverse osmosis system is composed of two major parts: the high pressure pump and the

membranes. The initial purified water production rate is measured at this pressure. It appears that

there are longer-term benefits to be gained by operating at lower percent water recovery,

particularly in reducing maintenance to the systems, and maintaining precipitation problems,

Impurities in water

Un-dissolved and

suspended solid materials.

Dissolved salts and minerals Dissolved gasesOther minerals


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which may arise due to operator error. It is important to realize that the purified water from a

reverse osmosis system is delivered essentially at atmospheric pressure, usually to a vented

storage tank.

In general, it cannot be operated by opening and closing a valve in the product water lines(unless special pressure relief is provided). The reason for this is that the high pressure in the

system drives the water across the membrane, and no flow of water would be possible if the

pressure on both sides of the membrane were the same. If for some reason, the product water line

was closed while the system was operating. The pressure would build up. Of course, if the

purified waterside off the system were strong enough, the problems, which may arise due to

operator error, would be minimized.

2.1.3.Process chart

Utility area


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2.2. Air System

Air supplied by the engineering unit is of two types: HVLP (High Volume Low Pressure) air

& LVHP (Low Volume High Pressure) air. HVLP is maintained through Air handling Unit

(AHU) and LVHP is used as compressed dry air.

Air Handling Unit

AHU is a device used to condition and circulate air as part of a heating, ventilating, and air-

conditioning system. It is usually a large metal box containing a blower, heating or cooling

elementsfilterracks or chambers, sound attenuators, anddampers. Air handlers usually connect

toductworkthat distributes the conditioned air through the building and returns it to the AHU.Sometimes AHU discharge (supply) and admit (return) air directly to and from the space served

without ductwork.

The air handling unit affects to the temperature and humidity inside the building. In this case the

control is based on several principles. The supply air temperature is kept constant to allow the

adjustment of temperature in each room with separate thermostats or dampers. The supply air

humidity must not exceed a certain level. Also the circulation of air should always be sufficient.

AHU components

Blower/ fan

Heating and/or cooling elements

Filters

Humidifier

Mixing chamber

Heat Recovery Device

Controls

Vibration isolators
http://en.wikipedia.org/wiki/Fan_%28mechanical%29http://en.wikipedia.org/wiki/Air_filterhttp://en.wikipedia.org/wiki/Air_filterhttp://en.wikipedia.org/wiki/Air_filterhttp://en.wikipedia.org/wiki/Damper_%28architecture%29http://en.wikipedia.org/wiki/Damper_%28architecture%29http://en.wikipedia.org/wiki/Damper_%28architecture%29http://en.wikipedia.org/wiki/Duct_%28HVAC%29http://en.wikipedia.org/wiki/Duct_%28HVAC%29http://en.wikipedia.org/wiki/Duct_%28HVAC%29http://en.wikipedia.org/wiki/Duct_%28HVAC%29http://en.wikipedia.org/wiki/Damper_%28architecture%29http://en.wikipedia.org/wiki/Air_filterhttp://en.wikipedia.org/wiki/Fan_%28mechanical%29


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High efficiency particulate Air (HEPA)

HEPA filters are composed of a mat of randomly arranged fibers. The fibers are typically

composed of fiberglass and possess diameters between 0.5 and 2.0 micrometer. Key factors

affecting function are fiber diameter, filter thickness, and face velocity. The air space between

HEPA filter fibers is much greater than 0.3m. The common assumption that a HEPA filter acts

like asievewhere particles smaller than the largest opening can pass through is incorrect. Unlike

membrane filters, where particles as wide as the largest opening or distance between fibers

cannot pass in between them at all, HEPA filters are designed to target much smaller pollutants

and particles.

The particles are trapped (they stick to a fiber) through a combination of the following three

mechanisms:

1. Interception, where particles following a line of flow in the air stream come within one

radius of a fiber and adhere to it.

2. Impaction, where larger particles are unable to avoid fibers by following the curving

outlines of the air stream and are forced to embed in one of them directly; this effect

increases with diminishing fiber separation and higher air flow velocity.

3. Diffusion, an enhancing mechanism is a result of the collision with gas molecules by the

smallest particles, especially those below 0.1 m in diameter, which are thereby impeded

and delayed in their path through the filter.

HEPA filter remove at least 99.97% ofairborne particles0.3micrometers(m) in diameter.
http://en.wikipedia.org/wiki/Micrometrehttp://en.wikipedia.org/wiki/Micrometrehttp://en.wikipedia.org/wiki/Micrometrehttp://en.wikipedia.org/wiki/Sievehttp://en.wikipedia.org/wiki/Sievehttp://en.wikipedia.org/wiki/Sievehttp://en.wikipedia.org/wiki/Membrane_filterhttp://en.wikipedia.org/wiki/Membrane_filterhttp://en.wikipedia.org/wiki/Aerosolhttp://en.wikipedia.org/wiki/Aerosolhttp://en.wikipedia.org/wiki/Aerosolhttp://en.wikipedia.org/wiki/Micrometrehttp://en.wikipedia.org/wiki/Micrometrehttp://en.wikipedia.org/wiki/Micrometrehttp://en.wikipedia.org/wiki/Micrometrehttp://en.wikipedia.org/wiki/Aerosolhttp://en.wikipedia.org/wiki/Membrane_filterhttp://en.wikipedia.org/wiki/Sievehttp://en.wikipedia.org/wiki/Micrometre


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Nitrogen plant

1. It is used in pre & post filling of parenteral products.

2. Also used in pre & post integrity test of filter.

ETP (Effluent Treatment Plant)

All hazardous waste will be processed at Nandesari common disposal plant and then release

waste by converting in non-hazardous

Ai r (78% N2 +

21% O2 + 1%

other gases

BLOWERPass through

CMC material,

absorb O2 Nitrogen gas

(NMT 0.5%O2)

Water of

plant sewage

Add alum, 2

layers will be

separate out Lower layer

would be

rejected

Upper layer

will be

re-used


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3. PRODUCTION

Production is a functional area responsible for turning inputs into finished outputs through a

series of production processes. The production manager is responsible for making sure that rawmaterials are provided and made into finished goods effectively.

Chemist room

It is an area where all workers, machine operators and officers meet daily at the starting time of

their respective shift to plan complete schedule and allocate work activities.

In the room one white board displays 1 month projected manufacturing schedule of production

department in following format.

Sr, no. Mfg. date Filling

date

Product

name

Batch no. Batch size Remarks

1 15/05/2010 16/05/2010 Lotepred

LS

HKMJ0522 200 liter Domestic

2 16/05/2010 16/05/2010 Tropicamet HKMJ0513 100 literr Export

Label of Batch in Process

BATCH IN PROCESS

DATE:__/__/201

PRODUCT NAME

BATCH NUMBER

BATCH SIZE

MANFAACTURING SIZE

EXPIRY DATE

STAGE

CHECKED BY


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3.1. SOP (Standard Operating Procedure)

It is a document which prescribes an ideal procedure for each & every activity of company. It

strictly follows GMP (Good Manufacturing Practice)

Content of SOP:

Sr. no. Title Description

1 Title It is expressive of subject of SOP

2 CC No. Change control number

3 Supersedes Mention previous SOP number

4 Effective date Date on which SOP become effective

5 Purpose Mention intended use of SOP

6 Scope Application of SOP

7 Reference Detail of any reference used

8 Attachment Desired supportive documents attach with SOP

9 Annexure Documents serve as informative guidance

10 Distribution Area in which copy will be send to department

11 Definition of terms Define in Lehman language, easy for understanding

12 Procedure Systematic procedure as per GMP

13 History Any previous incident or abnormalities

14 Stamp In represent green colored stamp and copy number

As per the suggestions of WHO (World Health Organization) Unimed also translate all SOPs in

vernacular language (Gujarati) for easy understanding of workers and operators.

3.2. BMR (Batch Manufacturing Record)

It is a file which contains all the details of batch starting from raw material receiving to finish

good dispatch.

BMR preserved for 1 year more than expiry date of batch


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Content of BMR

Sr. no. Title Sr. no. Title

1 Product name 13 Washing of PPM

2 Generic name 14 Mfg process detail

3 Strength 15 Filtration detail

4 BMR status 16 Filling detail

5 Effective date 17 Sterilization detail

6 Supersedes 18 Calculation

7 CC no. 19 Accountability %

8 Batch size 20 Yield %

9 Material pick up list 21 Visual inspection record10 Master formula 22 History date

11 Signature log 23 Cycle time

12 Verification sheet

3.3. Introduction to areas of production department

a. De cartooning area

Here primary packing materials like ampoules and vials are received. Workers arrange ampoules

or vials into perforated plate which are directly sent to washing area through hedge. There would

be normal pressure and room temperature would be maintained.

b. Ampoules / Vials washing area

In this area ampoules and vials are being washes in two step process

1. Inner wash: by help of purify water, water for injection and compressed air one by one.2. Outer wash: by help of purify water & water for injection one by one.

Temperature of washing area should NMT 27oC & pressure NLT 0.4 mm of WC. (WC = water

column)


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c. Equipment washing area

Here parts of equipment or tanks has to be cleaned with help of purify water and then water for

injection.

Temperature of washing area should NMT 27o

C & pressure NLT 0.4 mm of WC (= water

column)

d. Dress washing area

Equipment has capacity to process 30 pairs of dress at once. Normal room temperature and

humidity would be maintained here.

e. Autoclave & DHS (Dry Heat Sterilization) area

Material or equipments used for preparation of parenteral products must pass through autoclave

or DHS, for sterilization.

This process leads to denaturation of protein of bacteria, results in death of bacterias. Autoclave

wiil lead to coagulation of protein of bacteria.

It has temperature NMT 27o C & humidity NMT 55%. Temperature will be automatically

recorded and printed at regular interval of 3 minutes.

f. Manufacturing area

Here active ingredients & excipient of final product have been mixed according to procedure of

BMR. Manufacturing area has to send in process sample of 30 ml for approval of QC

department.

In this area temperature, humidity, pH order of mixing and other parameters has to be followed

strictly.

g. Filtration area

Bulk solution or suspension is filtered through membrane or cartilage filter by help of nitrogen

gas with pressure of 0 to 2 Kg/cm2.


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Efficiency of filter is calibrated by bubble point test.

h. Filling and capping area

In filling area product is filled in respective containers. There are 3 different types of filling tube

stainless steel, glass & silicon.

Initial 5 vials or ampoules have been discarded in following cases:

Initial machine startup

Completion of maintenance work

Replacement of syringe & needle

Shift change

Tube filling machine- Unimed has only one product Eye mist Gel in tube form. It has 1 head.

Output rate is 30 tubes / min.

i. Visual inspection area

In this area every ampoules or vials have been checked by trained workers manually. Workers

are given target based work. Each worker has to submit eye report from government hospital.

Company takes on test for 100 ampoules, in which qualifying criteria is 97% accuracy. Visual

department also maintain several records. i.e. temperature measurement record, sequential log

sheet, daily visual inspection record, etc.

j. Freeze dry area

It works on principle of Lyophilization & Sublimitation. This process has capacity to remove

moisture from product by converting moisture in ice and then directly convert to vapor bypassing liquid stage.

Lupride Depot is freeze dried product and it Unimed is only manufacturer of this product in

India.


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k. Quarantine area

After completion of visual inspection, products are placed in this area. from this area, packing

department will receive products for labeling & secondary packing with help of Batch transfer

note

There are different color codes for different stages of products. Purpose of color code is to

identify product at each & every stage and to avoid a mix up of materials.

Sr. no. Color code Stage of product

1 Yellow Ready for packing

2 Pink Ready for visual

3 Orange Ready for leak test

4 Blue Ready for sterilization

5 Red Ready for rejection

Format of label:

UNDER PROCESS APPROVALDRUG NAME VISCOMET INJ 5 ML

STAGE READY FOR VISUAL INSPECTION

BATCH CODE HKNJ0555 BATCH SIZE 100 LT

MFG DATE 05/2010 EXP DATE 04/2012

CONTAINER NO. 1 OUT OF 50

BARCODE


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3.4. Capacity of equipments

SR. NO EQUIPMENT CAPACITY

1 Autoclave 2592 lit.972 lit.

2 DHS 1800 lit.2500 lit.

3 7000 units / hr.

4 Ampoule filling machine

5 Bottle filling machine 80 units / min.

6

7 Lyophilizer 200kg. ice condensation

8 Vial filling line 6000 units / hr4000 units / hr

9 Pre filled syringe machine 6000 units / hr

10 Tube filling machine 60 units / hr


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Packaging department

There are 6 different types of packing line in the packing department

1. Plastic bottle packing line

2. Vial packing line

3. Ampoules packing line

4. Multipack show box over wrapping packing line

5. Single pack show box over wrapping packing line

Layout of packing department quarantine:

BPR (Batch Packing Record):

It is a file which contains all details of packing materials like batch number, type of label, show

box, ply box, corrugated box, etc.

READY FOR

PACKING

PART

BATCHPACKED BATCH

SHREDDER MACHINEENTRY & EXIT

COOLER NO. 1

COOLER NO. 1


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Content of BPR:

Sr. no Title

1 Product name

2 Generic name

3 Strength (content of API)

4 BPR status(tentative, final or scale up)

5 Effective date

6 Supersedes

7 CC No.

8 Batch size

9 Signature log

10 Bill of material

11 Verification sheet

12 Calculation sheet

13 History date

14 Cycle time


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4.Quality Assurance Quality Control

Introduction

Quality department ensures that quality is built in the product through implementation of quality

assurance system & procedures. Quality department is responsible for ensuring safety, identity,

strength, purity and quality of each product manufactured at UTL.

Quality Assurance

Below mentioned activities comes under the responsibility of quality assurance department

Ensuring in process control

Raw material and packing material control

Batch record review

Finished product approval

Release finished product for sale/export

Process validationEquipment qualification

Cleaning validation

Change control programme

Event and incident investigation procedure

Document control

Self inspection


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Training

Handling of market complaint

Vendor evaluation

Factory hygiene

Quality control

Testing and compliance of the raw material & packing/packaging material to

approved specifications.

Compliance of in-process & validation samples to approved specifications.

Compliance of finished product to approved specifications.

QC insures quality system like

Stability study

Analytical method validation

Microbial purity control

Quality objectives

To insure strict adherence to SOPs (standard operating procedure) and cGMP in conformity with

WHO, various national and international standard

To audit the system against actual practices

To insure defined quality procedure

To train all department supervisors for good documentation practices.


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Activity flow chart

Receipt of raw and packing material

Sampling

Analysis

Approval of material

BMR/BPR Issuance

Dispensing of raw material

Manufacturing

In process checks

In process sampling

QC analysis

Intermediate stage release

BMR review by QA

Bulk preliminary approval by QA

Rejection of material

Transferred to rejection area

Return to vendor Disposal of material

Reprocessing


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Finished product sampling

Packing in process check

Review of batch record by QA

Final release by QA

Transferred to BSR

Control sample/ stability sample

withdrawal

QC release

Batch rejection

Batch destruction


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Document Mfg. and control Validation

Qualification matrix Training

Monitoring system Audit program

Change control Planned modification

Event investigation Market complain

Product recall Risk management

Annual product review Out of specification

Vendor qualification Quality management

review

Quality system


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Validation

Process Cleaning Computer system

Not satisfactory

Protocol approval

Analytical method

Execution work

Protocol review

Satisfactory

Protocol preparation

Change

RevalidationApproval

Evaluation

Report


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Part II

Dispatch and Import - Export


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5. WAREHOUSE

All the activities in the warehouse can be shown in the form of a diagram given below.

Receipt of raw materials and packing materials

Storage

Dispensing of raw materials

Issuance of packing material and raw material

Receipt of finished goods in BSR

Packing of cold chain products with coolant bags

Dispatch of finished goods


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RECEIPT AND HANDLING OF RAW MATERIAL

On receiving intimation from gate by security in-charge regarding any receipt of raw material,

the following matters/details are required tobe verified on the basis of suppliers bill challan.

Then suppliers bill/challan would be checked, whether the material is for our location, if yesthen material would be allowed inward.

Security will take entry in inward register and allow vehicle inside the factory. The security in-

charge will put the reference of the inward entry on the backside of the suppliers bill/challan/LR

(lorry receipt)

STORAGE OF RAW MATERIAL

Checks and precautions

Storage all the liquid raw materials on the lower most rack. Store the heavy containers at lower

level of rack. All the raw materials are to be stacked in proper rows, so that movement of the

materials at the time of issuance is easy.

Quarantine area

Store QUARANTINE materials in this area which are identified by yellow colored border

dedicated area/covered with nylon net/yellow rope (if applicable) with Quarantine coupon. Try

to store single consignment on one pallet, if consignment is large, use required number of pallets

ensuring proper segregation. Use separators in between for stacking different material on single

pallet.

Approved area

Store all approved materials in this area, which are identified by green colored Approved label.

Rejected area

Store all rejected materials in this area which are identified by red colored Rejected label

Storage area

Store all the raw materials in the area with respect to their storage conditions as per the list given

by QC. The various storage area available are

Temperature range Storage area

Less than 2oC Cold storage/refrigerator/cooling cabinet

Less than 25o

C A.C. store roomRoom temperature Respective location/ store room


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Depending on the status of materials like Quarantine/approved/rejected transfer the material to

its respective location. Whenever any non compliance is observed at any stage, inform the QC

department for defacing the approved label and affix the HOLD label if required.

In such cases where the non-compliance is observed for limited packs / containers instead of

whole lot, the same should be transferred to Quarantine area after affixing HOLD label.Necessary entries should be updated in ERP for the same.

After shifting the raw material to their respective location, update the locator code in the ERP

system and thereafter also whenever material is shifting from one location to another or one rack

to another, update the ERP system likewise.

Whenever any material (in-out) from (2o to 8o) refrigerator and (-14oC to -25oC) deep freezer like

for dispensing or sampling or any reason to be note down the entry in log book register.

ISSUANCE OF PACKING MATERIALS & RAW MATERIALS

Material pick up list is submitted by user department for which work order is released for issue

of packing material.

Procedure for issuance of packing material

Do not open sterile material outside of sterile area.

All packing materials which are to be issued against MIO must contain approved labels

Issue material and affix packing material issue coupon.

Arrange issued material on clean pallets.Counter check with material issue order.

Scan barcode before issuance of primary and secondary material.

Confirm MIO, print MIO

Deliver issue material with confirm MIO.

Ensure that all packing material are identified by properly affixing issue coupon dully

filled and signed and one set to be attached with confirmed MIO for user department.

Guidelines

Count all material like aluminum scales, non RFS rubber stopper by multiplying the qty.

mentioned by supplier for each packets and for loose quantity count the same on the basis

of average weights.

Sterile plastic bottles, plugs and RFS rubber stopper is to issue as per material issue

order. Issue intact packets in round of qty.


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Count all material by multiplying the qty. mentioned by supplier for each packets and for

loose quantity by physical counting of each item.

For issuance of labels, intact role of label issue as mentioned suppliers label quantity and

count all loose label on label counting machine.

DISPENSING OF RAW MATERIALS

Store department will receive material pickup list along with BMR from the production

department. System generates material pickup list on first expire first out basis. If ERP system is

not working than production will give manually request with authorization along with BMR.

Access articles option in the MIO for the number of RM coupons required in ERP system.

Material issue coupons will be printed out as per requirement. Raw material will be picked up

according to material pickup list. Ensure that all materials having approved labels. Materials ofone product will be collected at a time and arranges properly in staging room. Collect the

partially dispensed containers (loose) first, for dispense and keep the material on the pallet.

Reverse laminar airflow shall be switched on before half an hour before starting dispensing and

pressure has to be within the limit. RLAF and dispensing room shall be clean. Balances should

be calibrated before use. Temperature not more than 30oC and humidity not more than 65% (or

as specified in BMR)

[Process: Material from staging room will be bought to dispensing room one by one for

weighing. Gross weight of raw material will be checked before starting of each dispensing and

record the same in raw material bin card. Scan the bar code. Wear clean and protective apparels.

Change plastic gloves after dispensing each material.]


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Other responsibilities

1. Handling of return material from production

Material can be returned in following conditions

Dispensed material but manufacturing planning changed and returned to

warehouse.

In case material is returned as online rejection due to not meet the requirements.

In case of excess packing material return.

All return material store as per defined storage condition & locator code defined in

material return coupons.

Confirm the material return memo, print, sign & give to user department.

2. Handling of rejected materials.

3.

Handling of spilled materials.

In case of spillage inform the QA.

In case of liquid spillage material would be handled as per MSDS (Material

Safety Data Sheet)

In case of solid material, workers will collect the material in poly bag, affix the

label of spillage and send it to ETP (Effluent Treatment Plant) for disposal.

In case of organic material spillage approved absorbent will be used for

absorbing.

Spillage report will be prepared and authorized by quality head, department head

and plant head.

4. Handling of damaged goods.

First of all intimate the quality assurance for spot observation through intimation

fir damaged consignment/containers.

During the QA examination if material will be rejected then it would be treated as

mentioned earlier.

Rejected material must contain label of rejected in spot observation

If the consignment/containers are to be rejected, return it back to the supplier.

If QA recommend to redress the material then redress it in dispensing area under

QA supervision.

Redress the material in suitable container and record the data. Affix the redressinglabel on container with having all the details of original container. If possible than

retain the original label. The dully filled redressing form signed by warehouse and

QA officer shall be attached with goods inward memo.

A GIM will be prepared with the remark of spot observation and would be sent to

QA department.


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6. Dispatch

At the Unimed a standard procedure for dispatching is being followed strictly. This procedure

ensures the quick dispatch of finished products into the market within very less time after the

manufacturing of product.

Warehouse receives RFC (Rolling Forecast) every month from the corporate. RFC is a list of

products to be dispatched in the month. The same RFC is also sent to the production department

for manufacture planning during the month.

The whole dispatching process can be shown in form of a simple chart given below

Documentation


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Meanwhile the dispatching process proceeds, documentation process will also proceeds simultaneously.

The list of required documents is given below.

Details of documents for dispatch of finished goods:

Name of document Document source

1 Excise bill in duplicate ERP

2 Stock transfer note ERP

3 Form 402 Printed form

4Form AR-2 for state excise product

Printed form MS Excel / open Office, signed

by excise inspector

5 Lorry receipt Transporter

6 Original and triplicate of out pass Warehouse

7Form ARE-1 / ARE-2 / AR-4 for export

Printed form MS Excel / open Office, signed

by excise inspector wherever applicable

More ERP based documents

1. QC order

2. Distribution Order

3. Distribution Issue

Above mentioned documents are not require to send with dispatched goods, but they are

the part of standard procedure to be followed.

Dispatch procedure

Authorized officer prepares the list of products to be dispatched with full details as per shown

below.

Item code

Description of the item

Rate of excise duty to be charged while billing

Batch no.

Total quantity

Total no. of boxes

Quantity in loose boxes

Retail price per unit

Instruction for dispatch:


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For the dispatch of finished products warehouse follows the RFC. RFC provides the required

quantity of various products to be dispatched and emergency in percentage. The product having

maximum requirement will produce first and dispatched as soon as possible and other products

would be dispatched as per descending order in RFC.

Finished goods release by QA:

After the goods receiving in BSR, QA will take samples from the batch. Number of samples

depends upon the size of batch.

Batch size No. of samples

Up to 2000 10

2000 to 50,000 50

Above 50,000 100

Until the completion of QA analysis ERP system doesnt allow further documentation. After the

satisfactory result QA make necessary entries in the ERP system and system shows the batch

ready to dispatch.

Excise Invoice, Transfer Note

After QA release warehouse required to prepare Excise Invoice. Because Excise Invoice is a

very important document, authorized person refer the checklist given below prior to generate the

Excise Invoice.

Check List:

Destination wise separate product list

Total number of shippers and quantity in loose shippers

Total quantity = no. of full box * each full box quantity + quantity in loose boxes

Note down retail price

After the Excise Invoice the next step is to generate Transfer Note from ERP and get it

confirmed. Take printout of Excise Invoice as well as Transfer Note and get the same signed.

Attach all the relevant documents wherever applicable for the dispatch and get it stamped.

Security Out Pass Memo

To allow the goods outside of the company premise an authorized security out pass memo has to

be generate.


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Complete the necessary entries for the clearance in daily stock account in proper folio. Before

handing over the documents to driver ensure that the vehicle has been covered properly.

Material out pass memo would be sent to security in-charge who should check everything in

security point of view. The security in-charge should counter check the number of cartons

mentioned in the material out pass memo and his deputed guard counted while loading and allowthe vehicle outside the premise.

The security in-charge should also make the necessary entry in the material outward register and

keep the material out pass memo for future reference.

Unimed has two depots:

1. Vapi (Gujarat)

2. Bhiwandi (Maharashtra)

(Form-402 is required when consignment going to cross the border of state. It is

applicable for Bhiwandi, not for Vapi)

All the finished products are dispatches to either of these two depots. The next destination of the

Product would be C & F agent. A C & F agent forwards the product to SUN Pharma.


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7. Import

The wide portfolio of Unimed products requires large variety of raw materials from India and

foreign. Company imports various raw materials on regular basis from renowned organizations

of Europe, America and some other countries.

Import procedure is very difficult which includes typical documentation and approval procedure

from many different government authorities at the different stages of import. As import

procedure became a regular practice at Unimed Company always apply for import at

concessional rate of duty So general import is known here as import at concessional rate of

duty.

Here the flow chart of the whole import procedure is produced in order to present the difficult

import procedure in simple form.

IMPORT AT CONCESSIONAL RATE OF DUTY

Application for registration

Application grant

Import

Bond acceptance procedure

Intimation for import/purchased material

Bond accepted by AC/DC

Import at concessional rate of duty


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Import of goods at concessional rate of duty for manufacture of Excisable goods:

These rules were amended in year 2002 and came into application at the first day of March 2002.

Earlier these rules were made in the year 1996 and were start to applied at 1st

September 1996.

Import Process:

1. Registration:

A manufacturer intending to avail of the benefit of an exemption shall obtain a registration from

the assistant commissioner of central excise having jurisdiction over his/her factory.

The registration shall contain particulars about the name and address of the manufacturer, the

excisable goods produced in his factory, the nature and description of imported goods used in

manufacture of such goods.

Then the assistant commissioner of central excise or deputy commissioner of central excise willissue a certificate to the manufacturer indicate the particulars referred above.

2. Application by the manufacturer to obtain the benefit:

A manufacturer who has obtained a certificate and intends to import any goods for use in his/her

factory at concessional rate of duty, shall make an application to the assistant commissioner of

central excise or deputy commissioner of central excise indicating the estimated quantity and

value of such goods to be imported. Applicant shall also provide details of port of import.

The manufacturer may at this option, file the application either in respect of a particular

consignment or indicating his estimated requirement of such goods for a quarter.

The manufacturer shall also give undertaking on the application that the imported goods shall be

used for the intended purpose only.

The application shall be countersigned by the assistant commissioner or deputy commissioner of

central excise who shall certify there in that the manufacturer is registered in his office and has

executed a bond to his satisfaction in respect of end use of imported goods in the manufacturers

factory and indicate the particulars of such bond.

3. Procedure to be followed by AC / DC of customs:

On the basis of application countersigned by assistant commissioner or deputy commissioner of

central excise, the assistant commissioner or deputy commissioner of customs at the port of

import shall allow the benefit of the exemption notification to the importer.

Provided that where the importer has field the application in respect of his estimated requirement

for a quarter, that said assistant commissioner of customs or deputy commissioner of customs


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shall debit in the said application, the quantity and value of import made under a particular

consignment, also indicating particulars of the bill of entry, before allowing the benefit of the

exemption notification to the importer.

The assistant commissioner or deputy commissioner of customs will forward a bill of entry

containing the particulars of import, the amount of duty paid and other relevant particulars to theassistant commissioner or deputy commissioner of central excise.

4. Procedure to be followed by AC / DC of central excise:

The assistant commissioner or deputy commissioner of central excise shall acknowledge the

receipt of intimation received from the assistant commissioner or deputy commissioner of

customs.

5. Manufacturer to give information regarding receipt of imported goods and

maintain records:

The manufacturer shall give information of the receipt of imported goods in his factory, within

two days (excluding holidays, if any) of such receipt, to the superintendent of central excise

having jurisdiction over his factory.

The manufacturer shall also maintain a simple account indicating the quantity and value of goods

imported. The quantity of imported goods consumed for the intended purpose and the quantity

remaining in stock, bill of entry wise. The organization has to present this account as and when

required by the assistant commissioner or deputy commissioner of central excise.

6. Recovery of duty in certain case:

The AC/DC of Central Excise shall insure that the goods imported are used by the manufacturer

for the intended purpose and in case they are not so used take action to recover the amount equal

to the difference between the duties liviable on such goods but for interest, at the rate fixed by

notification issued under section 28AB of the customs act, 1962 for the period starting from the

date of importation of the goods on which the exemption was availed and ending with the date of

actual payment of the entire amount at he difference of duty that he is liable to pay.


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Documents:

a. Annexure-I

Broad description of the exemption notification No. 36/96-cus.

b. Annexure-II

It is a registration certificate. It shall be obtained from assistant commissioner or deputy

commissioner of central excise.

Assistant Commissioner of central excise issue the registration certificate in triplicate

Annexure-II

Original Registration holder

Duplicate Range superintendent

Triplicate AC of Central Excise

AC holds triplicate copy for reference of his office and send duplicate to superintendent so that

he can register the assessee in his office as a authorized importer.

c. Annexure-III

It is an application form. Each time assessee want to import the raw material, he/she shall obtain

the Annexure-III and fill up as per guidelines. After fill up the form he/she need to send theapplication to superintendent of central excise in quadruplicate copy. Superintendent verifies the

application and forwards it to AC of Central Excise.

Annexure-III

Original AC of customsDuplicate Range superintendentTriplicate AC of central excise for officeQuadruplicate Registration certificate holder

AC endorses the necessary details and forwards the approved application to AC of customs at the

port of import (an airport or sea port where imported material will arrive).

I.e. factory of applicant is situated at Vadodara but imported material is to arrive at Chennai

airport than AC forwards the original approved application to AC of customs at Chennai airport.


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d. Annexure-IV

It is a bond under the customs

e. Annexure-V

It is an intimation document shows receipt of goods at the factory premise. It should be

submitted to superintendent of central excise (having authorization over his/her factory) within

two days of receipt of goods at factory.


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8. EXPORT

The export contract

Introduction

Whenever any goods produced in the factory anywhere in India leaves the factory premise, it is

liable to excise duty. But in order to promote the export government provide 100% exemption on

duty paid by exporter. This way exporter gets relief from

1. 5% basic excise duty

2. 2% of basic duty as education cess3. 1% secondary and higher secondary education cess

Unimed exports its products in countries like, Guyana, Thailand. Mauritius, Netherlands,

Algeria, Peru, Russia, South Africa etc.

The first step of export is export contract. An export contract (also referred to as a sales contract)

is essentially an agreement between exporter and a foreign importer to do business. The export

contract can take many different forms. For example:

1. A telephonic offer to sell, covering essential issues such as the product details, quantities

offered, price per unit, delivery particulars and payment terms, made by the exporter to

the foreign buyer (or an offer to buy from the importer to the exporter) and confirmed by

the second party is one example of a legitimate export contract.

2. Similarly, any written offer (quotation), either contained in a formal written contract and

posted or couriered to the importer, or sent by e-mail, fax, telex or cable to the importer,

and confirmed (usually also in writing) by the importer, is another form of legitimate

contract.

3. A Proforma invoice sent by fax, e-mail, courier or post to the importer (usually on his/her

request) and confirmed by the importer is another common form of export contract. The

confirmation could be as simple as the importer writing "I agree to these terms and


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conditions" on the proforma invoice and signing it or perhaps the importer may generate

a separate, signed document agreeing to the proforma invoice which is then attached as

reference.

The first offer is seldom accepted

It is seldom the case that the importer will accept the first offer made by the exporter and

normally this first offer will be followed by a series of counter-offers sent back and forth

between the exporter and the importer until each party is satisfied with the terms and conditions

outlined in the final offer and agree to abide by it.

Be clear and precise

Whatever form the export contract takes, you need to be careful in formulating this document as

they are drawn up between companies from countries which may have very different legal

systems, regulations and attitudes to doing business. These differences may cause disputes even

when trading with other fairly developed nations. The challenge is to make your export contracts

as clear, precise and comprehensive as is possible.

The provisions in the contract

The basic provision of any contract for the sale of goods is that you, the seller (in this case, the

exporter), will transfer ownership of the goods to your buyer (the importer) in exchange for

payment (which, in international trade, made be made in a foreign currency). The export contract

needs to specify the terms and conditions for doing this, and should at least describe:

Who is party to the contract

The validity of the contracts

The goods being sold (usually described in some detail)

The purchase price of the goods and the currency in question

The terms of payment

Inspection of the goods if required

Where the goods should be delivered


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At what point transfer of title to the goods takes place

Any warranty and/or maintenance conditions associated with the sale

Who is responsible for obtaining import or export licenses, if these are required

What supporting documentation and/or certificates are required

Who is responsible for paying import duties and other taxes

Any contract performance security requirements, such as bank letters of guarantee

What will happen if either of the parties defaults or cancels

The provisions for independent mediation or arbitration to resolve disputes, and whether

this would take place in South Africa or the importer's country, or elsewhere

The contract's completion date

The role of Incoterms

To provide a common terminology for international shipping and minimize misunderstandings

over contract terms, the International Chamber of Commerce has developed a set of terms known

as Incoterms. These are the basic terms used in international sales contracts, and you can learn

more about them at the Incoterms 2000 Web site or in the Glossary of International Trade Terms

in Appendix A.

Intellectual Property (IP)licensing contracts are particularly tricky

If the contract involves the licensing of proprietary information or technology, be very sure that

it's precise about the licensee's rights. Vagueness about these rights can create serious problems

and can lead to the loss of your intellectual property. If the licensee uses your technology to

create other technologies, for example, this can severely undermine the value of your asset.

Contract must be signed by all contracting parties

Also - and this would seem obvious, but it's sometimes overlooked - be sure that all parties to the

contract have signed it. For instance, if you're working through a representative, be sure that the

actual buyer signs the contract. The representative's signature is not necessarily enough, because

without the buyer's signature, there is no written evidence that the buyer owes you money. Last

but certainly not least, have the contract examined by a lawyer familiar with the export market.


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Export process:

In exercise of the powers conferred, the Central Government hereby, directs that rebate of whole

of the duty paid on excisable goods (hereinafter referred to as materials) used in the

manufacture or processing of export goods shall, on their exportation out of India, to any country

.

(1) Filing of declaration. - The manufacturer or processor shall file a declaration with the

Assistant Commissioner of Central Excise or the Deputy Commissioner of Central Excise having

jurisdiction over the factory of manufacture describing the finished goods proposed to be

manufactured or processed along with their rate of duty leviable and manufacturing/processing

formula with particular reference to quantity or proportion in which the materials are actually

used as well as the quality. The declaration shall also contain the tariff classification, rate of duty

paid or payable on the materials so used, both in words and figures, in relation to the finished

goods to be exported.

(2) Verification of Inputoutput ratio. The Assistant Commissioner of Central Excise or the

Deputy Commissioner of Central Excise shall verify the correctness of the ratio of input and

output mentioned in the declaration filed before commencement of export of such goods, if

necessary, by calling for samples of finished goods or by inspecting such goods in the factory of

manufacture or process. If, after such verification, the Assistant Commissioner of Central Excise

or the Deputy Commissioner of Central Excise is also satisfied that there is no likelihood of

evasion of duty, he may grant permission to the applicant for manufacture or processing and

export of finished goods.

(3) Procurement of material. The manufacturer or processor shall obtain the materials to be

utilised in the manufacture of the finished goods intended for export directly from the registered

factory in which such goods are produced, accompanied by an invoice under rule 11 of the

Central Excise Rules, 2002: Provided that the manufacturer or processor may procure materials

from dealers registered for the purposes of the CENVAT Credit Rules, 2002 under invoices

issued by such dealers.


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(4) Removal of materials or partially processed material for processing. The Assistant

Commissioner of Central Excise or the Deputy Commissioner of Central Excise may permit a

manufacturer to remove the materials as such or after the said materials have been partially

processed during the course of manufacture or processing of finished goods to a place outside the

factory -

(a) for the purposes of test, repairs, refining, reconditioning or carrying out any other operation

necessary for the manufacture of the finished goods and return the same to his factory without

payment of duty for further use in the manufacture of finished goods or remove the same without

payment of duty in bond for export, provided that the waste, if any, arising in the course of such

operation is also returned to the said factory of the manufacture or process; or

(b) for the purpose of manufacture of intermediate products necessary for the manufacture or

processing of finished goods and return the said intermediate products to his factory for further

use in the manufacture or process of finished goods without payment of duty or remove the

same, without payment of duty for export, provided that the waste, if any, arising in the course of

such operation is also returned to the factory of manufacturer or processor;

(c) Any waste arising from the processing of materials may be removed on payment of duty as if

such waste is manufactured or processed in the factory of the manufacturer or processor.

(5) Procedure for export. - The goods shall be exported on the application in Form A.R.E. 2

specified in the Annexure to this notification and the procedures specified in Ministry of Finance

(Department of Revenue) notification No. 42/2001-Central Excise (N.T.), dated the 26th June,

2001 shall be followed.

(6) Presentation of claim of rebate.

The claim for rebate of duty paid on materials used in the

manufacture or processing of goods shall be lodged only with the Assistant Commissioner of

Central Excise or Deputy Commissioner of Central Excise having jurisdiction of the place

approved for manufacture or processing of such export goods.


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Documents required for rebate claim:

1. Form R: this form is a application for refund or rebate claim of excise duty

2. Original, Duplicate and Triplicate copy of ARE- 2

3. Duplicate copy of Excise Invoice

4. Self certified true copy of Shipping Bill

5. Self certified true copy of Custom attested Invoice and Packing List.

6. Self certified true copy of Airway Bill.


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Documentation:

Introduction

The export process is made more complex by the wide variety of documents that the exporter

needs to complete to ensure that the order reaches its destination quickly, safely and without

problems. Documentation requirements for export shipments also vary widely according to the

country of destination and the type of product being shipped. Most exporters rely on an

international freight forwarder to handle the export documentation because of the multitude of

documentary requirements involved in physically exporting goods and it is strongly

recommended that you also make use of a freight forwarder to help you work your way through

the maze of documentation.

The benefits of documentation

Documentation is a key means of conveying information from one person or company to

another, and also serves as permanent proof of tasks and actions undertaken throughout the

export process.

If the documentation is complete, accurate, agreed upon by the parties involved and signed by

each of these of the parties (or their representatives), the document will represent a legally

binding document.

Function of export documentation

Export documentation may serve any or all of the following functions:

An attestation of facts, such as a certificate of origin

Evidence of the terms and conditions of a contract if carriage, such as in the case of an

airway bill


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Evidence of ownership or title to goods, such as in the case of a bill of lading

A promissory note; that is, a promise to pay

A demand for payment, as with a bill of exchange

Documents required for export:

1. Retail invoice (2 copy)

2. ARE 1(5 copy)

3. ARE 2 (6 copy)

4. COA (Certificate Of Analysis)

5. Commercial Invoice (3 or 5 copy)

6. Packing List

7. Bill of Lading

8. Shipping Bill

9. Certificate Of Origin

Documents required for transport:

1. Bill of lading

2. Airway bill

3. Freight transit note

4. Road consignment note

5. Export cargo shipping instruction

Documents required for payment:

1. Commercial Invoice

2. Letter of credit

3. Transport documents

Insurance documents:

1. Marine insurance


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Introduction to all the documents:

1. Certification:Introduction

In exporting, it is quite common for cargos to require a variety of certificates, including

certificates of origin, certificates of value, certificates of health, Consular certificates, etc. before

they are permitted to be imported into the country of destination. The purpose of a certificate is

to provide preshipment confirmation of the status of a particular aspect (health, value, condition,

origin, etc.) of a specific cargo.

Certificates of origin

A Certificate of Origin (C/O) is required by some countries and is intended to certify to the

importing authorities as to which country the products being imported were manufactured in -

that is, the C/O certifies that the imported product meets the 'Country of Origin' requirements set

by the importing country and which are expected of their foreign suppliers. It may be required

that the C/O include information such as local material and labour content.

Certificates of Value (and Origin)

A Certificate of Value is intended to confirm the value of a cargo to assist in quick clearing of

the goods in the country of destination. Often the Certificate of value is combined with a

Certificate of Origin and is referred to as a Certificate of Value and Origin (CVO). A CVO

outlines details about the labor and packing costs, royalties or commissions (if applicable),

freight charges and any overseas insurance costs. The CVO also provides an exporter's

declaration and statement, in the form of clauses, about the value and origin of the goods.

Fumigation certificate

Some countries, such as Australia, Canada, New Zealand, the US and the UK, are very strict

about letting in goods that might contain bacteria or insects that could harm their agriculture.

Fumigation certificates usually contain details such as purpose of treatment, the articles in


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question, temperature range used, chemicals and concentration used, etc. Sometimes they may be

required for sea shipments, but not for air shipments.

Certificates of health

Certificates of health are normally required by the importing country to ensure that the imported

goods (plants, plant products, animals and animal products) are in good health and carry no

diseases, pests or any health-threatening organisms. Such certificates of health confirm

(a) The origin of the shipment and,

(b) That local authorities have inspected the consignment and ensure its good health. Certificates

of Health can be divided into two types:

Phytosanitary certificates which are required for the import of certain plants and plant

products such as seeds and flowers.

Veterinary certificates which are required for the import of live animals, as well as fresh,

chilled or frozen animal products. For contact details go to.

Pre-shipment inspection certificates

It is not uncommon for importers to want to confirm that the to-be-exported goods meet their

requirements. This is particularly so in instances where it is essential that the goods meet certain

standards, they may:

a. Require that the shipment be inspected just before loading by an independent third-party

arranged and generally paid for by the importer.

b. Ask the exporter to obtain the pre-shipment inspection certificate from an independent

third-party inspection firm which is then forwarded to the importer.

The independent contractor - usually a recognized firm in this field - will undertake a detailed

inspection of equipment or materials after manufacture, but prior to shipment. The scope of the

inspection includes quantity and quality, packing and marking and supervision of loading.


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2. The Airway billAir waybills (AWB) are a form of BOL (Bill Of Lading) and are used for both domestic and

international flights. An AWB (also referred to as air consignment note or airway bill of lading)

refers to a documentary receipt issued by a carrier (i.e. airline) in favor of a shipper for goods

received and is evidence of the contract of carriage to carry the goods to a specified airport under

specified conditions, but it is not a document of title to the goods. It serves as:

Proof of receipt of the goods for shipment

Evidence of the contract of carriage

An invoice for the freight, reflecting the shipper, the consignee and the goods being

shipped, as well as the full freight amount

A certificate of insurance (if carriers insurance is requested by the shipper)

A guide to airline staff for the handling, dispatch and delivery of the consignment

A means of clearing the goods through customs

Usually, the AWB consists of three originals and nine copies. The first original is intended for

the carrier (airline) and is signed by the exporter (or agent); the second original the consignee's

copyis also signed by the exporter (or agent) and accompanies the goods; the third original is

signed by the carrier and is handed to the exporter (or agent) as a receipt for the goods after theyhave been accepted for carriage.

Types of air waybills

There are two types of air waybills used for the international transportation of air cargo:

The "airline air waybill", with preprinted issuing carrier identification,

The "neutral air waybill" without preprinted identification of the issuing carrier in any

form and used by other bodies than air carriers (such as freight forwarder).forma invoice


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3. Proforma invoiceIntroduction

A Proforma invoice is little more than a pre advice of what will stand in the commercialinvoice once negotiations have been completed. The proforma invoice serves as a negotiating

instrument. The initial proforma invoice often sets the stage for the first round of negotiations

if the exporter and importer have not yet had any real discussions.

Role of the Proforma Invoice.

Only one final proforma invoice is necessary to confirm that the two parties are indeed in

agreement. Every proforma invoice should be as precise and as explicit as possible to ensurethat both parties understand each other. If the importer is satisfied with this final proforma

invoice, he/she will request their bank to issue an L/C on the strength of information

stipulated in the proforma invoice.

Details pertinent to the proforma invoice

The following details are pertinent to the setting up of the proforma invoice and need careful

attention:

A complete and clear description of the goods in question

The quantity of goods in question including the number and kinds of packaging involved

The total price of the goods (and unit price where applicable)

The currency in which the goods will be sold (e.g. US dollars or rands)

The likely delivery schedule and delivery terms

The physical addresses of both the exporter (referred to as the shipper) and importer

(sometimes referred to as the consignee)

The payment methods, for example cash in advance or L/C

The payment terms, for example 30 days on sight

The Incoterm to be used


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Who is responsible for the banking fees and other related costs (insurance and freight

costs are covered by the Inco term in question)

The exporter's banking details

The country of origin of the goods

The expected country of final destination

4. Commercial invoiceIntroduction

After the pro-forma invoice is accepted, the exporter must prepare a commercial invoice. The

commercial invoice is required by both the exporter and importer. In exporting, the

commercial invoice is considered a very important document as it serves as the starting

document that underpins an export transaction.

The commercial invoice is essentially a bill from the seller to the buyer describing the goods

to be sold and the terms involved. The commercial invoice will normally be presented on the

exporter's letterhead and will be addressed to the importer. It should contain full details of the

consignment, including price and other related costs, in order to facilitate customs clearance.

It must be signed and dated.

What should appear in the commercial invoice?

The following details need to appear in the commercial invoice:

The name of the shipper/exporter and their contact details, including physical address

The name of the importer/consignee and their contact details, including physical address

An order number of reference to correspondence between the supplier and importer

A complete and clear description of the goods in question (including brandmarks and

the HS number)

The packing details unless provided in a separate packing list

The quantity of goods in question including the number and kinds of packaging

involved


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The external dimensions, cubic capacity, weight, numbers and contents of each package

shipped.

The total price of the goods (and unit price where applicable) usually quotes as a

CIF/FOB price

The currency in which the goods will be sold (e.g. US dollars or rands)

The type and amount of discount given

The likely delivery schedule and delivery terms

The payment methods, for example cash in advance or L/C

The payment terms, for example 30 days on sight

The Incoterm to be used

Who is responsible for the banking fees and other related costs (insurance and freight

costs are covered by the incoterm in question)

What the freight and insurance charges are

The exporter's banking details

A declaration of the country of origin of the goods

The expected country of final destination

Any freight details such as the port of loading and discharge

Any other information relevant to the order

5. Letter of creditIn this section we discuss the following topics and terminology within the area of documentary

credits:

Sight credits

This is an easy enough term to explain. A sight credit or L/C is one which paid upon presentation

of the required documentation to the issuing or confirming bank. An exporter need to be careful

however, as some L/Cs state that payment will only be made at a specified branch counter of the

issuing or confirming.


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Usance credits

An L/C can specify any credit period that you have negotiated with the importer. A letter of

credit that that incorporates a payment after a given term (e.g. 60 days) is known as a usance

credit (also referred to as a term or acceptance credit).

Transferable credits

An irrevocable L/C may also be transferable. In the case of a transferable L/C, the exporter can

transfer all or part of his/her rights to another party. Transferable letters of credit are often used

when the exporter is the importer's agent or a middleperson (i.e. export agent) between supplier

and importer, and not the actual supplier of merchandise. With a transferable letter of credit, the

exporter uses the credit standing of the issuing bank and avoids having to borrow or use his own

funds to buy goods from a supplier.

Revolving credits

The term "revolving" is used to describe a letter of credit, which, incorporates a condition

whereby the credit amount is to be renewed or reinstated automatically without the need for a

specific amendments to the credit. This type of credit is used when regular trade is conducted

between an exporter and an overseas buyer. A revolving credit can be irrevocable or confirmed.

Back-to-back credits

When an exporter, who is not a manufacturer, but obtains goods from a supplier by acting as an

export agent for the supplier for example, has received an L/C from an importer, the exporter, in

turn, may request his bank to open a L/C in favour of his supplier on the strength of the existing

L/C. These two credits are said to be "back-to-back", that is to say the one is issued on the

security of the other.

Standby credits

A standby L/C is one which is issued in favour of the exporter for the purpose of "backing-up"

certain specified obligations of the importer. A standby letter of credit requires the exporter's


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presentation of documents which indicate that importer has not met the obligations which the

standby letter of credit backs-up.

6. Packing lists:Introduction

When you prepare your goods for shipment, you will be required to prepare a detailed export

packing list. This is a formal document that itemizes quite a number of details about the cargo

such as:

Name and contact details

The importer's/consignee's/buyer's name, address and contact details The gross, tare and net weights of the cargo

The nature, quality and specifications of the product being shipped

The type of package (such as pallet, box, crate, drum, carton, etc.)

The measurements/dimensions of each package

The number of pallets/boxes/crates/drums, etc.

The contents of each pallet or box (or other container)

The package markings, if any, as well as shipper's and buyer's reference numbers

The purpose of the packing list

The packing list should be attached to the outside of a package in a waterproof envelope or

plastic sheath marked "Packing list enclosed". The list is used by the shipper or forwarding agent

to determine (1) the total shipment weight and volume and (2) whether the correct cargo is being

shipped.

Be careful while preparing packing list

It is important for you to realize that any mistake on the packing list may cause a delay in

clearance at the port of destination. Customs Authorities in the target country have the right to

delay the clearance of the shipment until the importer provides a packing list reflecting the real

contents of the container.


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7. Road consignment note:The road consignment note is :

Proof of receipt of the goods for transportation by road Evidence of the contract of carriage

An invoice for the freight, reflecting the shipper, the consignee and the goods being

shipped, as well as the full freight amount

A guide to the road hauler for the handling, dispatch and delivery of the consignment

A means of clearing the goods through customs

To clear the goods through customs, the road consignment note will need to be accompanied by

a commercial invoice, a packing list and any other documentation relevant for clearing purposes.

8. Freight transit order:A Freight Transit Order (FTO) is a form of inland BOL used in South Africa and required by

Spoornet, the primary rail operator in the country.

Transport documents and special Instructions

Spoornet has the following to say about transport documents:

Spoornet shall only accept goods into its care if it has been timeously furnished with fully

completed transport documents, or the relevant Electronic Data Interchange information,

by the consignor who warrants that all information reflected on the transport documents

is accurate in all respects.

The consignor shall indemnify Spoornet and hold it harmless against all losses, damages,

expenses and fines arising from any inaccuracy or omission made by the Consignor in thetransport documents.

Wherever it is necessary, for the purpose of these conditions or any other purpose

whatever, for special instructions such as stoppage or diversion of goods to be given to

Spoornet, such instructions shall only be recognised by Spoornet as valid if they are

timeously given and agreed to by Spoornet.


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9.Bill of lading (BOL or B/L):Introduction

A BOL is one of the oldest and most common forms of transportation documents in use today. It

is a document that establishes the terms of a contract between a shipping company (or its agent)

and the exporter/shipper (or agent, such as a freight forwarder). Within this contract, it is agreed

that freight is to be moved between specified points for a specified charge.

Some more detail

The BOL is normally completed by the exporter on forms issued by the shipping carrier. The

BOL serves as a document of title, a contract of carriage, and a receipt for goods. The BOL also

describes the kind and quantity of goods being shipped (such as the number of packages, the

weight and consignment dimensions), the shipper (or exporter), the consignee (the person or firm

to whom the goods are being shipped), the ports of loading and discharge, and the carrying

vessel.

Key points of BOLs

The key points that exporter should take note of, are:

The BOL is a legal contract between the shipper (normally the exporter) and carrier (the

shipping line represented by the ships master or shipping line representative)

As a legal document, the BOL plays an important role in releasing payment from the

bank in conjunction with the Letter of Credit

A BOL is a document issued by a carrier, e.g. a ship's master or by the carriers shipping

department, or a representative of either of these two

The BOL must be signed or authenticated by the person issuing the document The BOL must name the ship/vessel carrying the goods

The BOL does not afford the holder of the document any ownership of the goods listed in

the document (it is not a negotiable document)

The BOL acknowledges that specified goods have been received on board as cargo for

conveyance


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The BOL specifies both the ports of loading and discharge

The BOL normally has a named consignee

The BOL will specify the goods to be conveyed, their number, weight and volume

BOLs are usually issued in three originals; one for the exporter/shipper, one for the

shipping line and one for receiver/consignee of the goods.

10.ARE 1:

It is annexure 14: appli