gmp checklist

British Standards Institution

GMP Checklist Rev 0

BSI CHECK LIST FOR WHO GMP INSPECTION

1. GENERAL:

1.1 Date of Inspection

25th

to 28th

March 2008.

1.2 Name of the company

Hindustan Latex Ltd.

Plot No. 16 A/1 CSEZ, Kakkanad, Cochin – 682 037

1.3 Organizational chart of the Company (attach a copy)

Copy attached as Annex 1

Categories of Drugs / Products Manufactured

Female Condom (Nitrile Latex- Lubricated)

1.4 Do the firm/ company have a written quality policy? If yes, obtain a copy of the

Same and attach.

YES . Copy attached as Annex 2

1.5 Names of the members of the inspection team

NAME

DESIGNATION

SIGNATURE

1. VIJAY KUMAR MAGAN

Team Leader

2. S. MADHAVAN

Team Member

3. ------

----


GMP Checklist Rev 0

2. PERSONNEL

(i) Name of Incharge Qualification Whether Present/

Approved or not absent

a) Mr. G.Krishna Kumar B -Tech yes present (Unit Chief) b) Mr. Mahesh Kumar P. R B -Tech ---- present

(Unit In Charge) c) c) Mr. Rajesh G Joseph B -Tech ---- present

( Production)

d) Miss. Lijy T K M -Tech ---- present (Quality Control) e) Mr. A. Muraleedharan M-Tech ----- present f) Ms. Smitha B-Tech / MBA ----- present g) Mr. Venugopalan B-Tech ----- present

(ii) Number of Production Supervisors.

Mr.ALBY

(iii) Number of Analysts QA staff.

Mr. Lawrence and Mr. Sajith

(iv) Are Production and quality functions independent of each other?

Yes

(v) Are all sections adequately staffed (Supervisor / Asst. Mfg. Chemist) taking into

Consideration the work load?

Yes. Testing personnel needs to be FDA approved.

(vi) Is recruitment of an employee preceded by medical examinations?

Yes. Recruitment of employee could be preceded by medical check-up instead

of a certificate of physical fitness

(vii) What is the periodicity of subsequent medical examinations?

Once a year (Reference – site master file: Section 2. Personnel; sub-section 2.4

Health Requirement)

(viii) Is an employee whose state of health is doubtful immediately removed from work

site until he is fully recovered?

Yes. (Reference – site master file: Section 2. Personnel; sub-section 2.4 Health

Requirement)


GMP Checklist Rev 0

(ix) Do all personnel receive WHO GMP's training?

Yes. (Training included revised schedule M requirements of FDA pertaining to

GMP, and ISO 13485:2003)

(x) Is training documented?

Yes

(xi) What is the periodicity of training?

As the unit started in Nov 2007, only one training has been carried out in 2007.

(xii) Are protective steps against likely damage to health due to occupational hazards

satisfactory?

Generally yes. However, chairs used by various operators at visual checking,

electronic testing, etc.., needs to be ergonomically designed. Currently make-shift

arrangement is being made.

S.NO. CATEGORIES COMPLIANCE

Y/N/NA

REMARK/

COMMENTS

3.

(i)

(ii)

(ii-a)

(iii)

(iv)

(iv-a)

PREMISES

Are there are source of pollution in the neighbourhood of

the building?

Is plant layout of suitable size design & construction

sufficient for production and quality control of drug being

produced?

Any open drain, blocked sewer or public lavatory nearby?

Is there adequate space for equipment, material and

movement of personnel and material?

Is there any programme to check entry of birds, rodents

and insects?

Are any products other than drugs manufactured in the

N

Y

N

Y

Y

N

East – Road

South – Road

West – Software

North - Road

Site master file is

maintained

No drains inside

the production

area.

Procedure CEZF

28 includes pest

and rodent

control.

Procedure /

Program may

include control

for entry of birds

and insects


GMP Checklist Rev 0

(v)

(vi)

(vii)

(viii)

(ix)

(x)

same building?

Are buildings and facilities properly constructed to

facilitate adequate cleaning and sanitization?

Are lighting and Ventilation adequate?

Are facilities for changing street clothes, footwear,

washing and toilets adequate and satisfactorily

maintained?

Are sewage, trash and other effluent disposal adequate?

Whether production of other specified products like

hormones, cylotoxic drugs segregated or whether

production is carried out on campaign basis.

State of maintenance of building (Check whether the

firm/company have preventive maintenance programme)

Y

Y

Yes (Partially)

Y

NA

Y

CEZF28 Facility for changing street clothes, footwear for visitors may be considered. Discharged into common sewage treatment plant Organization may consider maintenance program for building with respect to painting, etc., Building stability certificate as per Indian Factories Act could be done.


GMP Checklist Rev 0

(xi)

(xii)

Are floors, walls and ceiling properly constructed and

easy to clean, maintain and disinfect?

Is there any programme for general housekeeping?

Y

Y

Requirements of Schedule M-III of Drugs and Cosmetics Rules 1945 for buildings could be followed. CEZF09


Y/N/NA

REMARK/

COMMENTS

4.

(i)

(ii)

(iii)

(iv)

STORAGE OF STARTING MATERIALS

Are there physically segregated areas for

- Raw materials?

- Packaging

Is there quarantine area for incoming raw material?

Is there segregated area for rejected material?

Are there separate areas for material requiring special

storage conditions e.g.,

- controlled temperature?

- Flame proof?

N

Y

Y

NA

No Physical

segregation of

RM & PM

areas. These

are stored in

the same

room with

proper area

identification. Quarantine/Rejected material is part of finished good area. A separate quarantine area could be considered.


GMP Checklist Rev 0

(v)

(v-a)

(v-b)

(vi)

(vii)

(viii)

(ix)

(x)

(xi)

(xii)

(xiii)

Are the areas adequate for storage of the materials in

relation to their amount and facilities provided?

Do all containers of active RMs excepients and

intermediates bear appropriate labels at all stages of

manufacture?

If no, give details

Are empty containers freed of old labels and checked

immediately prior to use?

Is lighting and ventilation adequate in warehouse?

Have the areas requiring special storage conditions

provided with monitoring devices and data maintained?

Is there any programme for general housekeeping?

Is there any evidence of entry of insects, rodents & birds?

Are there warehousing operating instructions?

Are these instructions being followed?

Are there labels for materials of different status i.e.,

quarantine, tested and released for use and rejected?

Are there labels of different colours?

Y

Y

NA

Y

Y

Y

N

Y

Y

Y

Y

Adequate for current level of single shift production Labels

available for

all stages

Temperature and humidity meters are provided S.O.P evidenced. Ref. CEZF 25 White -accepted; Pink – rejected; Yellow - Quarantine


GMP Checklist Rev 0


Y/N/NA

REMARK/

COMMENTS

(xii-a)

(xiv)

(xv)

(xvi)

(xvii)

Are labels on containers of RMs to be used in

manufacture checked with regards to identity, quantity, &

QA approval? If no, give details.

Are there the following information on labels?

- name of material?

- Batch number?

- Analysis number?

- Date of release/ rejection?

- Date of expiry?

- Date of testing?

Is the sampling performed by Qualities Control

personnel?

Are there sampling procedures?

Are there the following information of each sample

taken?

Y

Y

Y

N

Y

Y

N

Y

Y

Date of

testing in

incoming

material

record

CZEF08, CEZF23 CZEF08


GMP Checklist Rev 0

(xviii)

(xix)

(xx)

(xxi)

(xxii)

(xxiii)

- Name of person who performed sampling?

- Number of samples taken?

- Number of containers sampled

- Date of sampling?

Are the containers provided for storage of raw materials

suitable to preserve the quality?

Is there stock rotation programme (i.e., FIFO)?

Are the printed packaging material stored in orderly

manner and well separated to prevent mixing?

Are they recorded on stock cards/registers?

Are enclosed and locked areas provided for storage of

narcotic or highly toxic drugs?

Is exterior storage available:

- Solvent storage area?

- Inflammable material storage area?

- Whether safety measures provided have been

assessed by regulatory agency if any?

- Are SOP’s available for handling of these

materials?

Y

Y

Y

Y

Y

Y

Y

Y

NA

NA

NA

NA

NA

CEZF26

CEZF26


Y/N/NA

REMARK/

COMMENTS

5.

(i)

(ii)

(iii)

(iv)

(v)

(vi)

(vii)

WEIGHING AREA

Is the weighing area segregated?

Are lighting and ventilation adequate?

Is the area clean?

Do the personnel wear appropriate clothing?

Is there danger of cross contamination during weighing?

Are the scales & balance calibrated regularly and records

maintained?

Are the containers of the raw materials to be weighted,

Y

Y

Y

Y

N

Y

Y

Separate area

provided

CEZF32R01


GMP Checklist Rev 0

(viii)

(ix)

(x)

6.

(i)

(ii)

(iii)

(iv)

(iv-a)

(v)

cleaned before opening?

After weighing, are these containers sealed?

Are the raw materials for each batch, after weighing

properly identified?

Are adequately clean and dried equipments used for

dispensing materials from the containers?

EQUIPMENT

Is the equipment adequate for intended use? (State size,

capacity and check batch size)

Is it constructed in such a way that lubricants coolant, etc.

cannot contaminate the drug product?

Does the equipment permit cleaning and maintenance?

Does the equipment show its status i.e., clean, dirty, batch

contents?

Do all apparatus/equipment bear appropriate labels to

identity the product for which the equipment is used, its

batch no., date, etc.?

Are SOPs available for cleaning , maintenance and

sanitization

Y

Y

Y

Y

Y

Y

Y

NA

Y

CEZF27


GMP Checklist Rev 0


Y/N/NA

REMARK/

COMMENTS

(vi)

(vii)

(viii)

7

(i)

(ii)

(iii)

(iv)

(v)

(vi)

Are log books maintained for cleaning, maintenance and

sanitization of major equipment?

Are SOPs readily available to operators?

If automatic electronic or mechanical equipment is used,

are there?

- Written programmes for calibration/ inspection.

- Records of such programmes?

- Checks to ensure that any changes are made

only by authorised person?

FACILITIES AND UTILITIES

Are air handling units adequate and properly located

and functional?

Is air conditioning system adequate and functional?

Are steam generation facilities adequate and

functional?

Are vacuum system adequate and functional?

Is compressed air system adequate and properly

functioning?

Is water supply system adequate? Check whether MC

or Tube well supply. If tube well supply, whether

potable?

Y

Y

Y

Y

Y

Y

Y

Y

NA

Y

Y

Y

CEZF 27 CEZF27 CEZF32 CEZF32R01, CEZF32R02

The

condensing

units of air

conditioners

are installed

in finished

goods storage

area leading

to increase in

storage room

temperature

beyond 35*C

required for

the storage of

finished

goods.

For package

sealing


GMP Checklist Rev 0

(vii)

(viii)

(ix)

(x)

Is distilled water qualities and supply system

adequate?

Is demineralised water quality & supply system

adequate?

Sanctioned power ____________

Generator ______________ KVA provided

NA

NA

Y

N

60 KW

No generator

is provided.


Y/N/NA

REMARK/

COMMENTS

7-A

(i)

(ii)

(iii)

(iv)

(v)

(vi)

(vii)

SANITATION AND HYGINE

Are cleaning schedule available for:

- floors?

- walls?

- ceiling?

- doors & windows?

- electrical fittings?

For different sections.

Are SOPs available for cleaning & sanitization?

Are disinfectants used rotated?

Is microbial load monitored in different sections?

Is microbial load monitored in different sections?

Are adequate facilities available for personal hygiene

before entering into production area?

Are personnel instructed to observe personal hygiene?

Y

N

N

Y

Y

Y

Y

N

N

Y

Y

Cleaning

schedule

might include

walls and

ceiling apart

from floor,

door,

windows, etc.,

CEZF09

CEZF09 Bio-burden test conducted at packed stage CEZF28


GMP Checklist Rev 0

(viii)

(ix)

8.

(i)

(ii)

(iii)

(iv)

(v)

Are clean protective clothing provided to personnel?

Are clean sterile protective clothing changed every time a

person enters sterile area?

PRODUCTION AND IN-PROCESS CONTROL

Is there master production document for each drug

product being produced?

Are alterations to processes recorded and authenticated by

competent authorized persons?

Is the addition of components verified by another person?

Is an appropriate in-process control being performed?

Are non sterile products tested for microbial load &

whether microbial load is less than limits recommended

by WHO?

N

NA

Y

Y

Y

Y

Y

CEZF 11 CEZF20 CEZT015


Y/N/NA

REMARK/

COMMENTS

(vi)

(vii)

(viii)

(ix)

(ix-a)

Are adequate measures taken to prevent cross

contamination during production of different products in

the same facility?

If drying ovens are used:

- Whether one product is dried at one time?

Are instrument used for temperature, pressure or other

recording calibrated periodically and records maintained.

Are semi-finished products stored properly and are

identified?

Is stage of manufacture clearly indicated on containers?

NA

N

Y

Y

Y

CEZF32R01, CEZF32R02


GMP Checklist Rev 0

(x)

(xi)

(xi-a)

(xi-b)

(xii)

(xiii)

Is quality of water monitored?

The following points may be checked?

- source of water?

- Is it potable?

- In case de-ionized water source of feed water?

- Frequency of charging columns sampling

frequency?

- In case of water for injection information like:

- Is it prepared by distillation or reserve osmosis?

- Whether storage temperature is maintained at

not less than 800C and circulated?

Do the containers and closures meet required

specification?

Are containers checked for cleanliness and suitability for

packaging before use?

Are containers of intermediates FPs intended for use in

the plant closed property?

Is homogeneity maintained during filling of ointment,

creams and lotions?

Are the following controls carried out during filling

operations:

- checks of column, weight or counts?

- Visual inspection of empty and filled

containers?

- Visual inspection of closures?

Y

Y

Y

Y

NA

Y

Y

Y

Water is

supplied by

CEZ who

monitor the

quality of

water.

CEZF08

CEZF23


Y/N/NA

REMARK/

COMMENTS

(xiv)

(xv)

(xvi)

(xvii)

Is there adequate separation of packaging lines to prevent

mix-ups?

Is each line identified with name of the product, batch no.

and packaging size?

Is there only one batch of product on packaging line at

any given time?

Is an inspection carried out of each packaging line before

labeling and packaging operation?

Y

Y

Y

Y

Only one line

exist


GMP Checklist Rev 0

(xviii)

(xix)

(xx)

(xxi)

(xxii)

(xxiii)

(xxiv)

(xxv)

(xxvi)

Is the inspection verified by quality control?

Is significant discrepancy in actual yield investigated?

Is inspection carried out of each packaging line after

operation to ensure that all excess/rejected labeling

material are removed?

Are all excess or rejected coded labels and cartons

destroyed?

Is batch production record prepared for each batch of

product and maintained?

Do the batch production records indicate that each

significant step in manufacturing was performed and

checked by second individual wherever appropriate?

Are master instruction or procedures being followed?

Are these instruction and procedures being followed?

Are only materials, containers and appliances necessary

for the job in hand stored in the vicinity of the

manufacturing areas and are these properly labeled with

name of the product, batch no.. date, etc.

Y

Y

Y

Y

Y

Y

Y

Y

Y

CEZF10 CEZF 21 CEZF23 CEZF23 R10 Provided in SOP

S.NO. CATEGORIES COMPLIA

NCE

Y/N/NA

REMARK/

COMMENTS

9.

(i)

PRINTED LABELLING AND PACKAGING

MATERIAL CONTROL

Is specimen copy of each label and printed packaging

material approved before sending it to the printer?

Y


GMP Checklist Rev 0

(ii)

(iii)

(iv)

(v)

(vi)

(vii)

10.

(i)

(ii)

(iii)

Are label and other printed packaging material checked

and approved by quality Control before release to

production.

Is access to labels and other printed packaging material

store limited to authorized persons?

Are there any designated individuals to control and issue

labels and other printed packaging materials?

Are individual labels stored separately?

Are printer’s count accepted or counted by factory worker

for inventory purposes?

Do batch production records indicate:

- Number of labels or other printed packaging

materials to be issued?

- Batch or control code?

- Reconciliation of number/ amount of labels and

printed packaging materials issued, used and

destroyed?

QUALITY CONTROL

Are master control procedures:

- Signed and dated by responsible persons?

Do these control procedures include specifications, test

procedures or other control procedures for:

- Raw materials?

- In-process materials?

- Packaging and labeling materials?

- Finished products?

Are the procedure in written form and readily available to

QC personnel?

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y

CEZF08

CEZF 45 CEZF 45 CEZF 45

CEZF 08 CEZF 20 CEZF23

Provided in SOP

S.NO. CATEGORIES COMPLIA

NCE

REMARK/

COMMENTS


GMP Checklist Rev 0

Y/N/NA

(iv)

(v)

(vi)

(vii)

(viii)

(ix)

(x)

(xi)

(xii)

(xiii)

(xiv)

(xv)

(xvi)

(xvii)

Are there procedures and specifications for acceptance of

reprocesses materials?

Are there written sampling procedures for:

- raw materials?

- Packaging and labeling materials?


Are samples collected by QC personnel?

Is there special room for microbiological and sterlity

testing?

Is the environment of room controlled?

Cultures, Sub cultures:

- Are microbial strains obtained from

authorized / reputed source?

- Frequency of Sub-culturing.

- frequency of identification of organism by

microscopical or biochemical test

- Are records of subculturing and identification of strain

maintained

Are animal test performed?

Are animal properly housed?

Are the temperature and humidity of animal house

controlled?

Are records of animals used maintained?

Are the animal quarantined on receipt and examined for

infection / disease?

Is access to animal house restricted to authorized persons?

Is fresh water and animal feed available in animal house?

Are all raw materials , containers, closures, labels and

printed packaging materials approved and released by QC

for use in manufacture of drug product?

Y

Y

Y

Y

Y

NA

Y

NA

NA

NA

NA

NA

NA

NA

NA

Y

CEZF12 CEZF 08 CEZF 20 CEZF 23


GMP Checklist Rev 0


Y/N/NA

REMARK/

COMMENTS

(xviii)

(xix)

(xx)

(xxi)

(xxii)

(xxiii)

(xxiv)

(xxv)

(xxvi)

(xxvii)

Are in-process controls carried out by QC personnel?

Are semifinished products tested for appropriate tests

when necessary?

Is bulk finished products tested for established

specifications before packing?

Is every finished products tested for established

specifications before release for sale?

Are there any deviations from established procedures or

specifications and are these justified?

Does the QC maintain records of all the test carried out?

Does the QC reviews all production and control records

to ensure compliance with established written procedures

before a batch of the products is released for sale?

Reference Standards:

(a) Are reference standards (R.S.) available?

(b) Are these primary or working R.S.?

(c) Are working RS calibrated against primary R.S>

or C.R.S.?

(d) Are R.S. stored properly ( at low temperature

under dehumidified conditions)?

(e) Are records of R.S. and their calibration

maintained?

Are samples in sufficient quantity for testing twice

retained of starting materials and finished products for

future examination, in case of need?

Is written programme available for stability studies

including the following:

Y

Y

NA

Y

N

Y

Y

Y

Y

Y

Y

CEZF20

CEZF23

CEZF23R10

Display

boards

available in

production

unit

Retained

samples for

conducting all

the test once

is kept

Stability study

conducted by


GMP Checklist Rev 0

- Sample storage condition?

- Room temperature?

- Accelerated ageing test?

- Sample size and test intervals?

- Reliable and specific test methods?

- Testing in the same containers closure system

in which it is marketed?

- Date and expiration date?

F.H.C is

referenced in

the technical

file.


Y/N/NA

REMARK/

COMMENTS

11.

(i)

(ii)

(iii)

(iv)

(v)

(vi)

(vii)

12.

(i)

STORAGE OF FINISHED PRODUCTS

Is the area adequate with reference to materials stored?

Are lighting and ventilation adequate?

Whether special areas with temperature and humidity

control required? Have these been provided?

Is there stock rotation programme (FIFO)?

Are the inventory records to show:

- amounts?

- Batch number?

- Date of receipt?

Have distribution records been maintained?

Do distribution records provide sufficient information for

drug recall purpose?

Is there segregated area for retrieved goods?

Are records available for retrieved goods?

DOCUMENTATION

Are SOPs available for the following:

- receipt of raw materials and other components?

- Quarantine and storage?

- Quality control system and approval/rejection?

- Release to production?

- Weighing and dispensing?

- Processing and production operations?

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y

N

Y

Y

Y

Y

Y

CEZF25 CEZF25R01

CEZF25R01

No retrieved

goods

CEZF38 CEZF38, CEZF26 CEZF29 CEZF25 CEZF25


GMP Checklist Rev 0

- Packaging and labeling?

- Quality control?

- In-process?


- Storage of finished products?

- Distribution?

- Returned goods?

- Recalls and complaints?

- Cleaning and maintenance?

- Quality control of water?

- For reworking of nonconforming batches in

existence?

If yes, check records.

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y

CEZF05 CEZF19 CEZF29 CEZF20 CEZF25 CEZF25 CEZF25 CEZF 43

CEZF43 CEZF09 CEZT 20 CEZF21


Y/N/NA

REMARK/

COMMENTS

(ii)

(iii)

(iv)

(v)

(vi)

Have these SOPs been prepared, signed and dated by

responsible person?

Are there additional documents like log books, notebooks

or other similar records available to show execution of

various functions?

In case of review and changes, are SOPs signed by

responsible person and do these shoe their date of

effectiveness?

Are there records of receipt of raw materials and do these

have following information? (Goods Receipt Note-GRN)

- Receiving GRN document number?

- Date of receipt?

- Supplier?

- Manufacturer?

- Manufacturer’s batch number?

- Type and size of containers?

- Number of containers and conditions?

Are there records of stock and issue of raw material and

do these have following information:

- Opening balance?

- Date of receipt

- Quantity received?

- Name and batch number assigned by the

manufacturer?

- Invoice number, date, name and address of

supplier?

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y

Provided in

SOP

CEZF11R04 QMS 04B

CEZF 38R01 CEZF 26R05


GMP Checklist Rev 0

(vii)

(viii)

- Analysis report number and date?

- Date of expiry

- Date of issue?

- Name and batch number of product for

manufacture of which issued?

- Balance?

- Signature of issuing persons?

Is there a master formulation record for each drug

product being produced?

Is there a separate master production documents for each

dosage form/ batch size?

N

Y

Y

Y

Y

Y

Y

Y

One device being manufactured for which dosage quantity of Silicone Oil is deined


Y/N/NA

REMARK/

COMMENTS

(ix)

(x)

(xi)

Are these master production records signed and dated by

competent person? Do they show the following

particulars:

- the name, strength and description of the dosage

form?

- Name and quantity of each active ingredient per

dosage unit or per unit of weight or measure of

the drug product?

- The total weight or measure of any dosage unit?

- A complete list of components identified by the

name/codes?

- An accurate statement of the quantity of each

component?

- Calculated excess of component, if any?

- Theoretical weight or measure at appropriate

processing stage?

- Description of containers, closures and

packaging materials?

- Complete manufacturing instruction?

- Sampling and testing procedures?

Including in-process controls?

Specifications and precaution to be taken?

Is a batch production record prepared for every batch

produced?

Is it reproduction of the appropriate master production

Y

Y

CEZF11R01


GMP Checklist Rev 0

(xii)

(xiii)

(xiv)

documents or it has all critical information about the

batch.

Has it been checked for accuracy signed and dated by a

responsible person?

Are the records maintained by QC for all the test carried

out?

Do these records include:

- graphs, chart, spectra, etc?

- calculations?

- Signatures of individuals who performed the

test?

- Signatures of the designated person responsible

for the review of records for accuracy and

compliance with established standards?

Are other associated records available?

Y

Y

Y

Y

Y

Y

Y

Y

CEZF46RO1


Y/N/NA

REMARK/

COMMENTS

(xv)

(xvi)

(xvii)

13.

(i)

(ii)

(iii)

Is documentation available readily for examination?

Where errors have been made in entering or transcribing

data:

- Have errors been crossed out with one line?

- Have corrections been made above those

crossed out?

- Are corrections dated and initialed?

Are batch production records capable of giving complete

history of the batch right from the RM stage to the

distribution of FP?

CALIBRATION OF INSTRUMENTS AND

MEASUREMENT SYSTEMS

Are the balances calibrated routinely?

Have measuring equipments been calibrated?

Have thermometers/thermocouples been calibrated?

(calibrated range)

Minimum-25ºC

Maximum-35ºC

Y

Y

Y

Y

Y

Y

CEZF11R01

CEZF32R01 CEZF32R01 CEZF32R01 CEZF32R02


GMP Checklist Rev 0

(iv)

(v)

(vi)

(vii)

Note:

14.

(i)

(ii)

Have the pressure gauges been calibrated?

Are instruments routinely calibrated?

What is the periodically of calibration?

Are records maintained for all calibration?

Draw a list of all major instruments available and check

calibration records?

VALIDATION AND REVALIDATION

Are validation studies carried out for the following:

- Cleaning and sanitation procedures?

- Process?

- Testing?

Have qualification studies been carried out for equipment

before validation studies?

Y

Y

Y

Y

N

Y

Y

Y

6 months/ 1

year

List of

instruments

under

calibration is

maintained.

CEZF 31

CEZF31


Y/N/NA

REMARK/

COMMENTS

(iii)

(iv)

(v)

(vi)

Note:

Are validation protocols available for validation studies?

Do the validation reports show recorded results and

conclusions?

Are validation studies carried out periodically?

Is revalidation carried out in event of significant change

in material (s) or equipment?

Check a few qualification and validation studies in

details:

Y

Y

Y

Y

Only one

validation

carried out on

17.12.2007

Validation

report

17.12.2007

checked.


GMP Checklist Rev 0

15

(i)

(ii)

(iii)

(iv)

(v)

(vi)

(vii)

(viii)

16.

(i)

(ii)

COMPLAINTS

Are there written procedures for handling complaints?

Is an investigation carried out wherever necessary

including discussion with manufacturing personnel?

Are complaints reviewed by QC?

Is there a designated person for overall evaluation?

Are records maintained for complaints and do these

include the following:

- name of the product with strength?

- Batch number?

- Name of complainant?

- Nature of complaint?

Is a report of investigation made?

Are complaints involving adverse reactions evaluated by

qualified personnel?

In case of significant adverse reaction, are appropriate

Health Authorities notified?

PRODUCT RECALLS

Is there written procedure for product recall in case of

products known or suspected to be defective?

Is there a designated person responsible for execution and

coordination of product recalls?

Y

Y

Y

Documented

procedure for

handling

customer

complaint

CEZF 43.So

far no

customer

complaints

received.

Documented

procedure for

product recall

Ref.

CEZT024 No product

recall till date.


Y/N/NA

REMARK/

COMMENTS

(iii)

(iv)

Have the degrees of recall been specified (i.e., Degree I,

degree II and Degree III)

Is the following information available?

- fax, telex, telephone number and addresses of

national, regional and local regulatory

Y

Degree of

recall not

specified.


GMP Checklist Rev 0

(v)

(vi)

(vii)

(viii)

17.

(i)

(ii)

(iii)

(iv)

authorities?

- Fax, telex, telephone number and addresses of

radio, television and press agencies?

- Fax, telex, telephone number and addresses of

distributors, wholesalers, hospitals, etc.?

- Fax, telex and telephone numbers and addresses

of competent authorities of the countries to

which the drug products are exported?

Is there a system so that distribution records are readily

available to the designated person responsible for product

records?

Is the progress of product recalls recorded and final

report issued including reconciliation between the

delivered and recovered quantities of the product?

Is the effectiveness of product recall evaluated from time

to time.

Is there a segregated area for recalled product?

RETURNED AND SALVAGED DRUG PRODUCTS

Are written procedures available for receipt and control

of returned products?

If a reason for returning the product implicates other

batches is an investigation made and reports prepared?

Are returned or salvaged drug products destroyed unless

QC determines their reprocessing?

Are records of returned products maintained including

their disposition?

Y

NA

NA

N

Y

No recalls reported.

No segregated

area for

recalled

product

considered in

the lay-out.

CEZT 23

No product

returns

reported


GMP Checklist Rev 0


GMP Checklist Rev 0


Y/N/NA

REMARK/

COMMENTS

(v)

18.

(i)

(ii)

(iii)

(iv)

(v)

(vi)

(vii)

(viii)

(ix)

(x)

19.

(i)

(ii)

Are there written procedures for reprocessing and do

these include.

- Specifications and characteristics for approval?

- Identification of batch to reflect reprocessing?

- Revised stability data, if necessary.

SAFETY

Is a safety manual available?

Are safety equipments like helmets, shoes, goggles,

glove, showers, aprons, masks, breathing apparatus, etc.,

available in the factory?

Is adequate first aid equipment available at convenient

place in the factory

Is periodic first-aid training given to staff?

Are electrical connections, wiring etc. checked regularly?

Is flame- proof equipment used where flammable

solvents or materials are stored or handled during

manufacture?

Is adequate fire fighting equipment like fire

extinguishers, ladders, fire buckets filled with water/

sand, etc., available?

Are staffs trained in fire fighting operation?

Is the building safe and provided with emergency exit,

escape routes ladders, etc?

Does the firm maintain accident history/record?

If yes, comment on its adequacy.

POLLUTION CONTROL

Are arrangements for the following adequate?

Disposal of solid/semi-solid waste?

NA

Y

Y

NA

Y

Y

Y

Y

NA

Safety manual

not available.

However,

emergency

preparedness

plan and

response for

fire and

spillage is in

place.

Necessary

safety

equipments

are available

Only fire

extinguishers

are provided.

Emergency

exits in

building must

open outside


GMP Checklist Rev 0

(iii)

Disposal of sewerage?

NA


Y/N/NA

REMARK/

COMMENTS

(iv)

(v)

(vi)

(vii)

20.

(i)

(ii)

(iii)

1.

2.

Disposal of liquid laboratory waste?

Management of gaseous pollutants?

Is effluent treatment plant in existence?

If Yes, comment on it.

Are fume hoods of adequate design in existence and used

wherever necessary?

RESULTS OF PREVIOUS SELF INSPECTION AND

CORRECTIVE MEASURES TAKEN

Is the report of previous self-inspection available?

Recommendations of previous self-inspection?

Whether corrective measure have been taken as

recommended by previous self-inspection team?

PARENTERAL SECTION

Whether separate sections are provided for preparation of

the containers and closures. Preparation of solution,

Filling and Sealing Serilisation.

Equipment: Whether as per shedule M Manufactring

Area:

i) Shortage equipment for ampoules, vials;

bottles and closures.

ii) Washing and drying equipment.

iii) Dust proof shortage cabinet.

NA

NA

NA

NA

Y

Y

Y

Y

NA

GMP

inspection

done

internally

once in 6

months. Last

inspection

done on

14.01.2008


GMP Checklist Rev 0

iv) Water still.

v) Mixing and preparation tanks or other

containers.

vi) Mixing equipment where necessary

vii) Filtering equipment

viii) Hot Air Steriliser

Asceptic Filling and Sealing Rooms:

ix) Bacteriological filters.

x) Filling and sealing unit under laminar flow

work station.

NA

NA


Y/N/NA

REMARK/

COMMENTS

3.

4.

General Room:

xi) Inspection room

xii) Leak testing equipment

xiii) Labelling and packing benches

xiv) Storage equipment including cold storage and

refrigeration, if necessary.

Whether rubber closures used are of natural or synthetic

origin. Whether closures properly cleaned and sterilized

(note the method). Are they tested as per ISI standards.

Whether the cleaning schedule on container and closures

maintained.

Whether the sterile containers and closures are moved to

the filling area without exposure in non-sterile area. Are

the following rooms with proper facilities provided

before entry in to the sterile area:

i) A room for removal of street clothes and

shoes provided with cupboards and racks etc.

ii) A room for washing & changing into sterile

overalls.

NA

NA


GMP Checklist Rev 0

5.

6.

7.

8.

9.

10.

iii) An airlock.

Whether personnel entering in the sterile area wear clean

sterile uniform. Head cover, footwear, masks and gloves

Made of such material which are not likely to shed fibres

(nylon, Dacron etc.)

Whether movement of personnel is restricted in the sterile

area.

Whether special procedure has been established for

entering and leaving the manufacturing area and sterile

area. Is the procedure displayed at the entrance of the

manufacturing area.

Are the furniture provided in the section satisfactory

(smooth and washable).

Whether sufficient UV lamps are provided in the airlock

and hatches.

a) Is the efficacy of UV lamps monitored? (Check

whether their daily burning hours are recorded and they

are changed after they have burnt the specified hours.)

NA

NA

NA

Y

NA

NA


Y/N/NA

REMARK/

COMMENTS

11.

12.

13.

14.

b) Are the UV lamps cleaned periodically?

Whether the solution preparation room and filling and

sealing rooms are air conditioned and provided with

filtered air to keep positive pressure. ( State the air-

conditioning system-central or individual air-conditioners

and the class of air cleanliness).

Whether ascptic handling is necessary and if so, whether

central air conditioners with HEPA filters are provided.

Whether distillation units properly and frequently cleaned

to eliminate contamination, pyrogenous matter,

particulate matter, etc.

Whether distilled water still is so designed to avoid mix-

up of water spra condensed water. Write the model of

DW plant used.

NA

NA

NA

NA

NA


GMP Checklist Rev 0

15.

16.

17.

Whether fresh distilled water is used for

a) Manufacturing operations (it should be within 3-4

hrs, of collection. If storing is necessary, it should

be stored at 800C and above).

b) Is the bulk distilled water tested for pyrogen?

c) Whether adequate precautionary measures are

taken to avoid contamination during collection

and transfer of distilled water to the solution

preparation room.

Whether aseptic handling is necessary. If so, whether

laminar airflow system is provided in the solution filling

area.

a) Is the plate count taken and the method used is

adequate?

b) Has the average number of colonies (standard

limit) been determined?

c) If so, is ir adequate (how it has been determined

and what is the limit)?

d) If the limit is higher than permissible on any day,

steps taken to find out the causes etc.

(check if the production is stopped.)

NA

NA

NA


Y/N/NA

REMARK/

COMMENTS

18.

19.

20.

Are there any devices provided to note temperature of the

air-conditioned area?

Is the solution filtered (note the type of filter used,

candles sintered, glass or membrane filter)?

If the products are to be manufactured by aseptic

technique, do they have filtering assembly with bacteria

retaining filters. Whether the efficiency of the filters

checked before operation.

Whether autoclave used is adequate and is provided with

an automatic device to record pressure, temperature and

duration of sterlisation and whether records are

Y

NA

NA


GMP Checklist Rev 0

21.

22.

23.

24.

25.

26.

27.

28.

29.

maintained.

Is the effectiveness of sterilizer checked (state the type of

indicators used)?

What system has been established to separate products

intended for sterlisation from products already sterilized?

Whether the dry air sterilizers and autoclaves provided

have been validated for sterilization before operation and

whether recoding device is provided.

How is the equipment sterilized if necessary?

Whether lot Nos are given separately for different lots of

autoclave load in the same batch and are they separately

tested for sterility.

Whether the net content of the liquid is checked.

Whether leak test for ampoules is performed.

Are the finished product visually examined for suspended

particles. Whether visual checking unit is adequate and

satisfactory.

Whether adequate equipment is provided for the

following operations checks and these checks are being

carried-out.

NA

NA

NA

NA

NA

NA

NA

NA

NA


Y/N/NA

REMARK/

COMMENTS

i) Cutting of ampoules

ii) Washing of ampoules, bottles & closures.

iii) Drying of ampoules, vials & bottles.

iv) Auto claving and sterilizing

v) Sterilising of containers & closures.

vi) Manufacture of distilled water.

vii) Mixing, preparation & storage of solution.

viii) Filtration of solution.

ix) Filling and sealing

x) Testing leak.

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA


GMP Checklist Rev 0

30.

1.

2.

3.

4.

xi) Testing of foreign particles with black and

white background.

xii) Cold storage, if necessary

Whether the equipment are designed for thorough

cleaning after each batch of operation.

OPHTHALMIC SECTION

(Drops, Solutions, Ointments, Suspensions, etc.)

Equipment whether as per Schedule M

i) Hot air oven electrically heated with

thermostatic control.

ii) Kettle, gas or electrically heated with suitable

mixing.

iii) Colloid mill or ointment mill

iv) Tube filling equipment

v) Mixing and storage tanks of stainless steel of

other suitable material

vi) Sintered glass funnel seitz filter or filter

candle.

vii) Liquid filling equipment

viii) Autoclaves.

Are the droppers properly cleaned and sterilized

(check whether the droppers are packed in sterile

cellophane packing. If supplied separately)?

Is a suitable bactericidal agent added to the preparation

(note the percentage of the substance added)?

Are collapsible tubes cleaned with nylon brushes and

high pressure air jet?

NA

NA

NA

NA


Y/N/NA

REMARK/

COMMENTS

5.

What is the method of sterilizing collapsible tubes? If

ethylene oxide is used for sterilization is residual gas

removed effectively.


GMP Checklist Rev 0

6.

7.

8.

9.

10.

11.

13.

Is a separate area provided near the ointment section for

melting, filtering and sterilization of petroleum base?

(note the arrangement for directly treasferring the sterile

base)

Are the coarse particles of drugs made to a fine powder

before incorporating into the ointment base? (Particle size

should be less than 50 microns in the finished products.)

Whether asceptic manipulations are carried out in a

conventional sterile area or under laminar flow system.

Whether sterile bulk materials and containers and

closures are moved into the sterile area without exposure.

Are the ointment tested for gross contaminations? (The

finished products must be free from Pseudomonas

aeruginosa.)

Whether integrity of filters test is carried (Bubble point

test) out or not in case of aseptic filling.

Other remarks.

N

gmp checklist

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