Professional Documents
Culture Documents
1. GENERAL:
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
3. ------ ----
2. PERSONNEL
(v) Are all sections adequately staffed (Supervisor / Asst. Mfg. Chemist) taking into
Consideration the work load?
(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)
(i) Are there are source of pollution in the neighbourhood of N East – Road
the building? South – Road
West – Software
North - Road
(ii) Is plant layout of suitable size design & construction Y Site master file is
sufficient for production and quality control of drug being maintained
produced?
(ii-a) Any open drain, blocked sewer or public lavatory nearby? N No drains inside
the production
area.
(iii) Is there adequate space for equipment, material and Y
movement of personnel and material?
(iv) Is there any programme to check entry of birds, rodents Y Procedure CEZF
and insects? 28 includes pest
and rodent
control.
Procedure /
Program may
include control
for entry of birds
and insects
same building?
(vii) Are facilities for changing street clothes, footwear, Yes (Partially) Facility for
washing and toilets adequate and satisfactorily changing street
maintained? clothes,
footwear for
visitors may be
considered.
(viii) Are sewage, trash and other effluent disposal adequate? Y Discharged into
common
sewage
treatment plant
(xi) Are floors, walls and ceiling properly constructed and Y Requirements of
easy to clean, maintain and disinfect? Schedule M-III
of Drugs and
Cosmetics
Rules 1945 for
buildings could
be followed.
(v) Are the areas adequate for storage of the materials in Y Adequate for
relation to their amount and facilities provided? current level
of single shift
production
(xii) Are there labels for materials of different status i.e., Y White -
quarantine, tested and released for use and rejected? accepted;
Pink –
(xiii) Are there labels of different colours? Y rejected;
Yellow -
Quarantine
(vi) Are the scales & balance calibrated regularly and records Y
maintained? CEZF32R01
(ix) Are the raw materials for each batch, after weighing Y
properly identified?
6. EQUIPMENT
(iv) Does the equipment show its status i.e., clean, dirty, batch Y
contents?
(i) Are air handling units adequate and properly located Y The
and functional? condensing
units of air
(ii) Is air conditioning system adequate and functional? Y 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.
(iii) Are steam generation facilities adequate and NA
functional?
(v) Are non sterile products tested for microbial load &
whether microbial load is less than limits recommended Y CEZT015
by WHO?
(xv) Is each line identified with name of the product, batch no. Y
and packaging size?
(ii) Are label and other printed packaging material checked Y CEZF08
and approved by quality Control before release to
production.
(iii) Are the procedure in written form and readily available to Y Provided in SOP
QC personnel?
Y/N/NA
(iv) Are there procedures and specifications for acceptance of Y CEZF12
reprocesses materials?
(xxiii) Does the QC maintain records of all the test carried out? Y
(xxiv) Does the QC reviews all production and control records CEZF23R10
to ensure compliance with established written procedures Y
before a batch of the products is released for sale?
(iv) In case of review and changes, are SOPs signed by Y QMS 04B
responsible person and do these shoe their date of
effectiveness?
(vi) Are there records of stock and issue of raw material and
do these have following information:
- Opening balance? Y
- Date of receipt Y CEZF 26R05
- Quantity received? Y
- Name and batch number assigned by the Y
manufacturer?
- Invoice number, date, name and address of Y
supplier?
GMP Checklist Rev 0
British Standards Institution
(vii) Is there a master formulation record for each drug Y One device
product being produced? being
manufacture
(viii) Is there a separate master production documents for each Y d for which
dosage form/ batch size? dosage
quantity of
Silicone Oil
is deined
S.NO. CATEGORIES COMPLIANCE REMARK/
Y/N/NA COMMENTS
(ix) Are these master production records signed and dated by Y
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?
(xiii) Are the records maintained by QC for all the test carried Y
out?
Do these records include:
- graphs, chart, spectra, etc? Y CEZF46RO1
- calculations? Y
- Signatures of individuals who performed the Y
test?
- Signatures of the designated person responsible
for the review of records for accuracy and Y
compliance with established standards?
Note: Draw a list of all major instruments available and check List of
calibration records? instruments
under
calibration is
maintained.
CEZF 31
(ii) Have qualification studies been carried out for equipment Y CEZF31
before validation studies?
15 COMPLAINTS
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?
No segregated
area for
recalled
product
considered in
the lay-out.
17. RETURNED AND SALVAGED DRUG PRODUCTS
CEZT 23
(i) Are written procedures available for receipt and control Y
of returned products?
No product
(ii) If a reason for returning the product implicates other returns
batches is an investigation made and reports prepared? reported
18. SAFETY
(ix) Is the building safe and provided with emergency exit, Emergency
escape routes ladders, etc? Y exits in
building must
(x) Does the firm maintain accident history/record? open outside
If yes, comment on its adequacy. Y
PARENTERAL SECTION
NA
iii) An airlock.
maintained.
25. Whether lot Nos are given separately for different lots of NA
autoclave load in the same batch and are they separately
tested for sterility.
1. OPHTHALMIC SECTION NA
(Drops, Solutions, Ointments, Suspensions, etc.)