ms-sd 0017 gmp audit to iso std (2)

8/6/2019 MS-SD 0017 GMP Audit to ISO Std (2)

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PZ Cussons Group GMP Audit v 1.1 Section 1.0 Introduction & Index

Introduction

This audit pro forma is based on the structure of the International Standards Organisation guideline to GMP - draft document - ISO DIS 22716The ISO document has passed the review stage has now been published

This audit document has a 1 to 5 scoring system to enable assessment of continuous improvement in the GMP area to be monitored

1 Indicates - non compliance, 2,3 & 4 indicate partial and increasing compliance, 5 is fully compliant

There are some audit questions which will only be scored either 1 or 5 ie No or Yes

Area

1 Introduction & Index

2

3

4

5

6

7

8

9

10

11

SheetNo.

Terms & Definitions

Personnel

Premises

Equipment

Raw Materials & Pkg components

Production

Finished product

Quality Control laboratory

Out of specification Product

Wastes


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PZ Cussons Group GMP Audit v 1.1 Section 2.0 Terms & Definitions

2 Terms and definitions

For the purposes of this document, the following terms and definitions apply.2.1 acceptance criteria

Numerical limits, ranges, or other suitable measures for acceptance of test results.

2.2 audit

2.3 batch

A defined quantity of raw material, packaging material or product issued from one process or series of processes so that it could be expected to be homogeneous.

2.4 batch number

A distinctive combination of numbers, letters and/or symbols that specifically identifies a batch.

2.5 bulk product

Any product which has completed processing stages up to, but not including, final packaging.

2.6 calibration

2.7 change control

2.8 cleaning

2.9 complaint

External information claiming a product does not meet defined acceptance criteria.

2.10 contamination

The occurrence of any undesirable matter (chemical, physical and/or microbiological) in the product.

2.11 consumables

Consumables are materials that are used up during cleaning or maintenance operations. These can be cleaning agents and lubricants for example.

2.12 contract acceptor

Person, company or external organization carrying out an operation on behalf of another person, company or organization.

2.13 controlVerification that acceptance criteria are met.

2.14 deviation

back to '1 Index & Introduction'

A systematic and independent examination to determine whether quality activities and related results comply with planned arrangements and whether these arrangements areimplemented effectively and are suitable to achieve objectives.

The set of operations which establish, under specified conditions, the relationship between values indicated by a measuring instrument or measuring system, or valuesrepresented by a material measure, and the corresponding known values of a reference standard.

Internal organization and responsibilities relative to any planned change of one or several activities covered by the Good Manufacturing Practices in order to ensure that all themanufactured, packaged, controlled and stored products correspond to the defined acceptance criteria.

All operations that ensure a level of cleanliness and appearance by means of the following combined factors, in variable proportions: chemical action, mechanical action,temperature, duration of application. It is the action of separating and eliminating generally visible dirt from a surface.


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2.15 finished product

A cosmetic product that has undergone all stages of production including packaging in its final container for shipment.

2.16 in-process control

Controls performed during production in order to monitor and, if appropriate, to adjust the process to ensure that the product meets the defined acceptance criteria.

2.17 internal audit

2.18 major equipment

Equipment specified in production and laboratory documents that are considered essential to the process.

2.19 maintenance

Any periodic or unplanned support and verification operations designed to keep premises and equipment in proper working condition.

2.20 manufacturing operation

Set of operations from the weighing of raw materials to the making of the bulk product.

2.21 out-of-specification

Examination, measurement or test result that does not comply with defined acceptance criteria.2.22 packaging operation

All packaging steps including filling and labelling which a bulk product has to undergo in order to become a finished product.

2.23 packaging material

2.24 plant

The location for production of cosmetic products.

2.25 premises

2.26 production

The manufacturing and packaging operations.

2.27 quality assurance

All those planned and systematic activities necessary to provide confidence that a product satisfies given acceptance criteria.

2.28 raw material

Any substance going into or involved in the processing of a bulk product.

2.29 recall

Decision made by a company to call back a product batch that has been put on the market.

2.30reprocessing

2.31 return

Internal organization and responsibilities relative to the authorization to deviate from specified requirements due to a planned or unplanned and, in any case, temporarysituation concerning one or several activities covered by the Good Manufacturing Practices.

A systematic and independent examination made by competent personnel inside the company. The aim is to determine whether activities covered by this guideline and relatedresults comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives.

Any material employed in the packaging of a cosmetic product, excluding any outer packaging used for transportation. Packaging materials are referred to as primary orsecondary according to whether or not they are intended to be in direct contact with the product.

Physical location, buildings and supporting structures used to conduct receipt, storage, manufacturing, packaging and control and shipment of product, raw materials and

packaging materials.

Re-treatment of all or part of a batch of finished or bulk product of an unacceptable quality from a defined stage of production so that its quality may be rendered acceptable byone or more additional operations.


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Sending finished cosmetic products which may or may not present a quality defect back to the plant.

2.32 sample

One or more representative elements selected from a set to obtain information about that set.

2.33 sampling

Set of operations relating to the taking and preparation of samples.

2.34 sanitization

2.35 shipment

Set of operations relative to the preparation of an order and its putting in a transport vehicle.

2.36 waste

Any residue of a production operation, transformation or use, any substance, material, product that its holder intends for disposal.

Operation, used to reduce undesirable micro-organisms on inert contaminated surfaces depending on the objectives set. It is the action of reducing generally invisiblecontaminants from a surface.


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PZ Cussons Group GMP Audit v 1.1 Section 3.0 Personnel

Area Detail Partially compliant Comments

Rating 1 Rating 2 Rating 3 Rating 4 Rating 5

3.2 Organisation Sudah ada nama, sampai dengan supervisor

Are there sufficient staff within QA QC area?

Are all currently shown QA QC posts filled? 3.3.1 Ada, tapi implementasi tidak full, tidak urgent

3.3.2 Do all personnel :-

- Know their position in the organisational structure Jelas ada SOP

- Know their defined responsibilities and activities

- Have a formal job description


ISO

Ref

Non-

Compliant

Fully

compliant

Do detailed organisation charts for whole company /sections exist?

Is QA / QC independent of production ie report tosenior site management not production?

Managementresponsibilities

Is there a clear statement within the Quality manualthat senior site management endorse and are activelyinvolved in GMP?

Is it clear in senior management job descriptions thatthey have responsibility for GMP?

Do intermediate management have GMPresponsibilities clearly stated in their job descriptionsand objectives

Do senior management define and communicate whoare authorised personnel?

Sudah ada QMR difactory. Dan sudah adapenunjukannya.

Responsibilities ofpersonnel

- Have easy access to the relevant documentationnecessary for their role

- Are they encouraged to report irregularities / nonconformities at the level of their role

- Have adequate education, training and skillsappropriate to their role

- Comply with the personal hygiene requirementsstated in GMP policy / guidelines


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3.4 Training Is specific GMP training provided?

Are general training needs identified?

Are there training programs in place for all individuals?

Are training programs regularly reviewed?

Is the effectiveness of training evaluated

3.5

Are they formally communicated to staff at all levels

Is it tailored appropriately to the level of the role of theindividual?

Are these programs appropriately tailored to theneeds and role of the individual?

Are there induction / training programs in place fornewly recruited personnel?

Are there assessments on the knowledge individualsgain from training

Personal hygiene &Health

Do hygiene programs exist for all areas of themanufacturing plant

Are the procedures / SOPs readily available tooperators.

Do all personnel clearly understand the requirementsof the program and the actions they need to undertake

As part of this program do personnel receiveinstruction on hand washing and why it is important tohygiene

Do all staff (and visitors) wear appropriate clothing /protective garments to ensure cosmetic products arenot contaminated - e.g. hair nets, overalls, gloveswhere appropriate

Is there a clear policy prohibiting smoking, drinkingand eating in production, storage and laboratoryareas?

Is it communicated to staff, enforced and clearlysigned?


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3.6

Are other unhygienic practices such as spitting etcprohibited in areas where the product may beaffected?

Are staff affected by illness or having open sores /lesions on exposed body surface instructed to reportthis to their line manager?

After assessment and if there is a risk ofcontamination of product are they then prohibited fromproduction areas?

Visitors & Untrainedpersonnel

Do procedures exist re visitors? ie they must besupervised at all times, what H&S information theyrequire, protective clothing etc

Are new personnel restricted from production areas

until they have received induction / minimum specifiedtraining?


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PZ Cussons Group GMP Audit v 1.1 Section 4.0 Premises



4.2 Type of areas No clear identification just A, B, C

4.3 Space Is the space allocated to these areas sufficient? 4.4 Flow

4.5 Crancking floor, no borended corner

Are they in good condition /state of good repair? Are windows non opening? n/a

Only in injection area screened are available

4.6 Staff facilities - Are the facilities provided adequate?

In injection area only

4.7 Lighting Is lighting installed in all operations areas?

n/a

4.8 Ventilation On going

Back to '1 Index & Introduction'

ISORef

Non-Compliant

Fullycompliant

Are there separate or defined areas for storage,production, QC, staff facilities etc?

Is there a defined and logical flow of materials /products through the production process

Floors, walls, ceilings,windows

Does the design / construction facilitate ease ofcleaning and sanitisation where necessary? Ie smoothsurfaces, rounded corners, chemically resistantsurfaces where necessary

Or if not then are they suitably screened to avoidingress of birds, insects, contaminants?

washing / toilets /changing

Are facilities separate from but located close toproduction areas so as to enable easy access?

where appropriate do changing rooms havedesignated clean side / dirty side

Do lockers exist so that personnel can securely storetheir personal belongings / company issue overalls /PPE?

Is the lighting adequate / meet any local legalstandards?

Are light bulbs protected / contained to ensure that ifthey break product is not contaminated?

If not - then is the product protected fromcontamination in other ways e.g.. conveyor covers etc

Is ventilation sufficient for the intended production

operations?


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Use Rentokil

N/A

4.9 Pipework, ducts

Are there regular cleaning schedules in place? Cleaning schedule only for building & Equipment

Drains N/A

4.10

No need specific reginnes

Are sanitization regimes / agents validated? Are cleaning agents used effective?

No Rounded corners, Cracking Floor.

4.11 Maintenance

Are suitable filters / meshes in place to preventingress of birds rodents, insects and externalcontamination?

If not - then is the product protected fromcontamination in other ways e.g.. conveyor covers,sealed areas around filling machines etc

Are these installed in such a way so that drips /condensation, or dust falling from them, does notcontaminate materials, products , surfaces andequipment?

Are roof beams, pipework, ducts exposed so that dustcould build up and contaminate the product?

Is the design of these such that dust build-up isminimised?

Wherever possible are they routed so as to avoidbeing directly overhead of production process?

Are exposed services away from walls to allow forease of cleaning? e.g. supported by brackets andseparated sufficiently for all round access for cleaning

Orif the above measures are not practical / possiblethen are specific measures in place to protectmaterials and the product from contamination?

Are drains, covered, kept clean and do not allow backflow?

Cleaning andsanitization of premises

Generally is the production environment kept in aclean and tidy manner

Are there scheduled cleaning and where necessarysanitisation regimes in place?

Are these regimes customised to the specific needs of

each area?

Is the clear aim of these programs to protect theproduct

Is the construction and materials of floors, walls etcsuch that they can be easily cleaned? e.g. smoothwalls & floors, joins between walls & floors arecurved / radiused.

Are the premises well maintained and in a good stateof repair?


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4.12 Pest Control Use Rentokil

Is there a pest control program in place?

Are the premises designed and constructed to prevent/ restrict access by birds, rodents, insects, pests andother vermin?


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PZ Cussons Group GMP Audit v 1.1 Section 5.0 Equipment



5.2 Equipment design In blow section

N/A

5.3 Installation

Is equipment suitably located to facilitate :-

Movement of materials

Use of mobile equipment Use by personnel Ease of access for cleaning Ease of access for maintenance

5.4 Calibration

Equipment have calibration log


ISO

Ref

Non-

Compliant

Fully

compliant

Is production equipment suitable design to preventcontamination of the product. e.g. lids on mixers etc?

Are vessels holding tanks, product containersdesigned and constructed to avoid productcontamination by dust or water?

Are transfer hoses , pumps, other productionaccessories when not in use kept clean, dry and

protected from contamination?

Are the materials equipment is manufactured fromcompatible with the product and any cleaning /sanitization agents?

Is production equipment easy to clean and sanitize?e.g. completely drainable, no dead legs in attachedpipework etc

Are all major items of equipment clearly labelled?(production equipment and storage vessels). Toensure correct identification in SOPS etc

Are all measuring instruments associated with

production and assessment of quality (ie labequipment) regularly checked and calibrated?

Does each item of equipment have a calibration log /history?

If calibration checks show unacceptable results / nonoperational - do procedures exist for equipment to besuitable flagged and removed replaced?

If calibration is unacceptable - is there a procedure tocheck product quality of previous batches to ensure nonegative effects on quality,


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5.5 Do cleaning programs exist for all equipment

Where required do sanitization regimes exist

Are sanitization regimes / agents validated? 5.6 Maintenance Is all equipment regularly maintained?

Do planned maintenance procedures exist? Do equipment maintenance logs exist?

5.7 Consumables

5.8 Authorisation

5.9 Back up systems

Are there fall back procedures if measuring equipmentcannot be replaced immediately?

Formulir inspection harian mesin produksi monitor /control temperatur dibuat th 2011

Cleaning andsanitization

Shedule only for building there is chance the door stayopen

Are these regimes customised to the specific needs ofeach item of equipment?

Is the clear aim of these programs to protect theproduct

Is sanitization frequency clearly specified in theprograms

Maintenance procedures must not affect productquality

Are defective items of equipment identified andremoved from service

Are the consumables used for cleaning sanitising ormaintenance of equipment checked to ensure thatthey do not adversely effect equipment or product?

Is access and control of production equipment limitedto authorised and properly trained personnel only

Are there fall back procedures if equipment that isfaulty cannot be replaced immediately?


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PZ Cussons Group GMP Audit v 1.1 Section 6 Raw materials and Packaging components



6.2 Purchasing

6.3 Receipt

6.4 Identification and status

Name of product on delivery document and packaging

Suppliers name

Suppliers batch reference code

Is their a dedicated area for this?

N/A

6.5 Release


ISO

Ref

Non-

Compliant

Fully

compliant

Does a formal evaluation and selection process existfor material suppliers.

Are technical clauses included within supplyagreements? Items such as specification acceptancecriteria, actions in case of defect / modification /rejection, transport conditions

Are there procedures in place to check thatpurchasing order, delivery note and the materials thatare actually delivered match

Are the containers goods are shipped in visuallyinspected upon receipt to ensure they are sound / notbeen tampered with

Are all containers / drums / sacks received correctlylabelled with following details:-

Are materials showing defects held / quarantinedpending a decision

Is this status of all materials clearly marked on the

container - ie accepted, rejected, quarantined.

Or if not? is there a clear system of another kind, inplace that can offer the guarantee that materialsconform to standard and are cleared to use

Are their appropriate systems in place to ensure onlyreleased - approved materials are used ie SOP re useof green stickered approved mats or movement of onlyapproved goods into designated areas

Is approval / release of materials carried out by an

appropriately competent and authorised person, ie QCsupervisor / manager


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- Supplier audited Not connducted

- test requirements agreed - test methods agreed

Evaluation in every 6 months, documented

6.6 Storage

Are all storage containers closed / sealed properly?

Are there periodic stock inventories conducted? 1 x in 6 months (stock opname)

6.7 Re -evaluation is shelf life data of materials and components known

Does a system for re-evaluation of materials exist

6.8 Water Quality Are there defined specifications for water quality N/A

N/A

N/A

N/A

If materials are accepted / approved solely on thebasis of suppliers C of A - have all the following beenconsidered / put in place:-

Has continuity of quality from the supplier beenclearly demonstrated - ie a system of vendorassessment in place or as a minimum evidence thatseveral shipments checked and all parameters foundto be correct / within limits etc

Are all materials stored in a correct and appropriatemanner

Is suppliers MSDS for material checked to ensure safeand appropriate storage is conducted

When necessary are storage conditions monitored (iecool rooms temperature checked regularly)

Install equipment or conduct temperature conditionregularly

Are Sacks, boxes trays of materials stored off the floor- it is acceptable for drums to be on the floor

If materials are repacked for any reason - has all theappropriate labelling been applied?

Are there procedures in place to ensure proper stockuse / rotation ie FIFO (first if first out)

Are there systems to communicate and investigatestock discrepancies

Is material shelf life monitored to ensure no out of timematerial is used

Do the treatment systems in place deliver water to thisspecified quality consistently

Are there systems in place to verify this by testing /

monitoringcan the water treatment systems be easily /periodically sanitised?


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N/A

N/A

Is the water treatment equipment set up to avoidcontamination / stagnation of water.

materials of construction and treatment chemicalsused must not adversely effect water quali ty


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PZ Cussons Group GMP Audit v 1.1 Section 7.0 Production



7.1 Principle At each stage of manufacturing and packaging operations measures should be in place in order to ensure finished products meet the defined and specified characteristics

7.2

7.2.1 Documents

- Equipment operation documents

- formulation of product

- material addition sequences,

- temperature profiles

- mixing times

- mixing speeds

- sampling points and instructions

- cleaning instructions

- Bulk transfer procedures

7.2.2 Start up checks

Is equipment is checked for availability

7.2.3 Batch number


ISO

Ref

Non-

Compliant

Fully

compliant

ManufacturingOperations

Is the relevant documentation available at each stageof the manufacturing operation and includes:

Is a batch card for product available which clearlystates unique batch number, records lot numbers ofmaterials used, quantities required and used, anybatch adjustments made and final approval of batch

Are detailed manufacturing instructions for the productavailable which should include:

Prior to manufacture is there a check to ensure

operators have all relevant & correctdocumentation toenable production to commence

Are all raw materials checked to ensure that they arecorrect and QC approved?

Is equipment is checked to ensure it is safe and inproper working order

Is equipment, if necessary, cleaned and sanitised

prior to use?

Is a unique batch number allocated to each batch ofbulk product made?


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7.2.4

7.2.5 In process QC controls

Is frequency of checks specified?

Are procedures in place for reporting of results

7.2.6 Bulk product storage

7.2.7

- to ensure they are not contaminated

- to ensure they are correctly labelled

- that containers are properly sealed closed

7.3 Packaging operations

7.3.1 Documents

- detailed instructions on pkg equipment set up

Is this properly recorded & linked to raw materialsused and filling codes on packaging to ensuretraceability is possible

Identification of inprocess operations

Are all raw materials weighed accurately and intoclean and appropriately labelled containers? Materialsmaybe weighed directly into mixing vessel providing

controls are in place to avoid errors

Are all items of equipment identifiable - ie mixers,pumps, key switches clearly labelled numbered?

Are all bulk raw material storage tanks clearlyidentified?

Are appropriate in process QC control checksspecified?

Are sampling points and sampling techniques

specified

Are procedures / actions in place to deal with out ofspecification results

Are out of specification results investigated, causedetermined and necessary improvement actions put inplace to prevent reoccurrence

Are all containers of bulk finished product clearlylabelled with product name, code, batch number

Are storage conditions for the product clearly identifiedand displayed? (If required)

Are maximum quantities of bulk product storageidentified?

Are there procedures in place to avoid excessiveproduction?

Re stocking of Rawmaterials

When quantities of raw materials are returned tostorage are containers / products checked

- that correct quantity of remaining material is shownon outside of container

Packaging operation should be carried out to specifiedand detailed documentation / specifications

Is the relevant documentation available at each stageof the packaging operation and does it include:

- filling equipment cleaning and sanitisationprocedures


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- details on how product should be palletised7.3.2 Start up checks

7.3.3 Batch number

- date product filled (time optional)

- which shift

- which packaging line

7.3.5

7.3.6 In process control

Is there a defined schedule for these tests?

Are agreed acceptance criteria / limits specified

7.3.7

- to ensure they are correctly labelled

- lists and standards of materials for the intendedfinished product

- check lists to ensure all pkg components areavailable

- details on how the product primary container shouldbe coded

Prior to filling is there a check to ensure that the areahas been cleared of all pkg components from previousoperations

Prior to manufacture is there a check to ensureoperators have all relevant & correctdocumentation toenable filling to commence

Do physical samples or photographs of the intendedproduct exist to act as standards for reference by lineoperators?

Are there checks to ensure that pkg components areavailable & correct quantity.

Are there checks to ensure labels are correct and barcodes are readable?

Are there checks to ensure that the correct pkgequipment is available and in good operation.

Are there checks to ensure filling equipment is cleanand where necessary sanitised?

Has the coding to be applied to the product been

issued and checked for accuracy?Is a unique batch number / code applied to theprimary pkg to enable identification of:

Is this coding recorded and linked to bulk productbatch code to ensure traceability is possible?

On line controlequipment

Is equipment such as weight checkers recorderschecked regularly to a defined schedule?

Are in process control checks such as product weight,cap tightness, label positioning etc in place?

Are procedures in place to deal with results that areout of specification?

Re stocking ofpackaging components

When quantities of packaging materials are returnedto storage are containers checked


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- that containers are properly sealed closed

7.3.8

Where they should be stored

- that correct quantity of remaining components isshown on outside of container

Identification andhandling of work inprocess

Filling and labelling is normally a continuous process.When this is not the case then procedures must be inplace to ensure product is not mixed up or mislabelling

occurs

Are there clear procedures in place that specify howstocks of unlabelled but filled product is identified


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PZ Cussons Group GMP Audit v 1.1 Section 8.0 Finished Products



8.1 Principles Finished products must meet the defined acceptance criteria

8.2 Release

8.3 Storage

Are there defined time limits for storage of products?


ISO

Ref

Non-

Compliant

Fully

compliant

Storage, shipment and returns should be managed ina manner to maintain their quality

Do acceptance release criteria exist for all finishedproducts

Are appropriate checks conducted on finishedproducts to ensure they meet all definedspecifications?

Do agreed and validated test methods exist for allchecks required?

Are operators / QC personnel suitable trained in thesemethods?

Are methods readily available to personnel inproduction / QC areas so they can check method

details if required

Is product release carried out by authorised personnelfrom the quality function?

Are products stored in an appropriate manner? Ieorganised / tidy / safe

Do SOPs exist which specify how products should bepalletised and stored - ie pallet configurations,maximum stacking limits, shrink wrapping of palletsetc

Are there defined and segregated areas for released,quarantined or rejected finished products?

Is there a defined process to periodically monitor thephysical quality of finished products?

Are pallets of finished products properly identified andlabelled? Ie with name / identifying code, batch

number etc


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Are periodic checks conducted on inventory? 8.4 Shipment

8.5 Returns

Are they clearly labelled as returns?

Are there systems in place to ensure there is properstock rotation / FIFO?

Do SOPs exist for checking cleanliness and integrityof transportation / containers

Are there defined processes to ensure products areproperly transferred into containers or onto lorries toensure quality is maintained - ie stackingconfigurations & limits, use of layer boards, use ofprotective materials re possible condensation etc

Are product returns stored in a defined andsegregated area?

Do procedures exist re what checks and what criteriaare applied to determine the status of returnedproducts ie acceptable product which can bereshipped / sold or product that requires rework orproduct that must be scrapped?

Is returned product release carried out by authorisedpersonnel from the quality function?

Are appropriate records kept to ensure return productreleased again for sale can be properly identified (iedistinguished separately from original production)


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PZ Cussons Group GMP Audit v 1.1 Section 9.0 Quality control laboratory



9.1 Principles 1 The principles described for personnel, premises, equipment, and documentation also apply to Quality control laboratory

3 The quality control manager must not report directly to operational level production management

9.2 Test methods

N/A

9.3 Acceptance criteria

The limit agree by quality and Marketing

9.4 Results

9.5


ISO

Ref

Non-

Compliant

Fully

compliant

2 The QC lab is responsible for ensuring the necessary and relevant controls are carried out for sampling and testing so that materials are released for use and products are releasedfor shipment, only if their quality fulfils the required acceptance criteria

Do documented test methods for all relevant qualitychecks / analysis exist?

Ada test methode untuk eqiupment : WI Cappng test(WI-QA-09), WI Uji tingkat kebocoran (WI-QA-07), WIWall thickness (WI-QA-07)

Are they subject to proper document controlprocedures? Ie issue date, issued by, authorised byetc

Are they based on recognised international stds orfrom professional bodies ie Iso ASTM British or othercountry stds

Are acceptance criteria / QC limits clearly detailed inraw material, packaging or finished productspecifications

Have these limits been reviewed and agreed to by al lrelevant parties? Ie Quality, production, marketingwhere appropriate

Are procedures in place to ensure that QC test resultsare reviewed and acted upon in a timely manner?

Are the levels of authority for personnel in QC toprovide decisions clear?

Out of specificationresults

Are out of specification results reviewed separately byauthorised personnel?

Are they investigated properly and reported on? Ieroot cause analysis, costs of incident, improvement /follow up actions recommended etc

If retesting is requested, has there been a properassessment to justify this action?


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9.6 Reagents etc N/A

9.7 Sampling Is sampling performed by suitable trained personnel Training MIL STD

9.8 Retained Samples

Are all reagents and chemical solutions, labelled andidentified correctly ie with name, strengthconcentration, initial date, expiry date, name or personwho prepared material, any special storage conditionsrequired.

Are all reference standards labelled and identified

correctly ie with name, initial date, expiry date, nameor person who prepared material, any special storageconditions required.

Are reference stds also approved by relevantmarketing function

Do SOPs for sampling exist that specify the method ,equipment amounts to be taken, sampling point, how

sample is to be identified and frequency of sampling?

Are samples properly coded / identified and detailsproperly recorded? Ie with name or code, batchnumber, time & date, where taken (sampling point /container tank, vessel etc)

Are retained samples of materials and intermediates(where appropriate) kept?

Is the sample size retained appropriate for anysubsequent re analysis which maybe required (due toissues or regulations)

Are retained samples of finished products taken andkept in their primary packaging?

Are these samples retained for specific periods eitherto company guidelines or to legal requirements?

Are all samples stored in an secure and appropriatemanner


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PZ Cussons Group GMP Audit v 1.1 Section 10.0 Treatment of product that is out of specification



10.1 Rejected products

10.2 For finished product returns see section 8.5 N/A

10.2 N/A

N/A

N/A

N/A

N/A


ISO

Ref

Non-

Compliant

Fully

compliant

Are procedures in place to deal with out ofspecification items These can be raw materials,packaging components, intermediates, bulk batchesor finished products

Are there appropriately qualified & authorisedpersonnel assigned to assess and deal with the nonconformance process

Do non conformance procedures include input /assessments of product from technical, legal,commercial, marketing etc depts (where appropriate)prior to end decision on release, rework, scrapping ofproduct?

Is authorisation to proceed given on basis of Qualitydept recommendation and final sign off by seniormanagement

reprocessed finished

products

reprocessed bulkproducts

Do procedures exist re what checks and what criteriaare applied to determine the status of the bulkproduct? ie criteria decision making process thatdecides if product can be reprocessed or needs to bescrapped

Is bulk product that requires reprocessing stored in adefined and labelled container / vessel /storage tank

Are there measures in place to ensure it cannot beused / filled off until decision has been made

Is reprocessed bulk product release (to specifiedacceptance criteria) carried out by authorisedpersonnel from the quality function?

Are appropriate records kept to ensure reprocessedbulk product can be properly identified (iedistinguished separately from original production)


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PZ Cussons Group GMP Audit v 1.1 Section 11.0 Wastes



11.1 Principal Efforts should be made to minimise waste generation in the first place. Any waste generated should be disposed of in a timely, efficient, safe and legal manner.

11.2 Types of waste

11.3 Flow

11.4 Containers N/A

11.5 Destruction of waste N/A

N/A

N/A


ISO

Ref

Non-

Compliant

Fully

compliant

Are wastes generated by the operation reviewed /studied to understand if they have any effect onproduct quality. or functionality of laboratory analysis)

Does the production and subsequent storage,

disposal of waste have any effect of factory /laboratory operations

Are any wastes generated disposed off in a timely,efficient and legal manner

Are containers of waste properly identified / labelledwith the contents and any appropriate health & safetyinformation (or other information that may be legallyrequired)

Are waste containers properly sealed and suitable forstorage of the wastes they contain?

If waste is disposed of on site, are adequateprocesses in place to ensure it is conducted properly?Ie safely, no harmful effects to environment, legally etc

If waste is disposed of externally and via a /contractor has the third party and its processes /modes of disposal, been audited

Is all waste disposed of according to legalrequirements?