GOOD MANUFACTURING PRACTICE AUDIT

(GMP AUDIT – CHECK LIST)

For Pharmaceutical Manufacturing Facilities

Good Manufacturing Practice – GMP Audit Checklist

Sr # (Contents) Page #

1. Quality Assurance ……… 03

2. Premises………. 04
3. Personnel………. 05
4. Validation………. 06
5. Documentation / Records………. 07

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6. Vendor Qualification………. 09
7. Change Control Program……… 09
8. Sample………… 09
9. Stability Studies………… 10
10. Drug Recall……… 10
11. Annual Product Review…….. 10
12. Audits……… 11
13. Quality Control Departments………. 12
14. Manufacturing Area……….. 13
14.1 Equipment…………. 13
14.1.6 Equipment Calibration………. 13
14.1.7 Material / Component ……….. 14
14.2 Raw Material………. 14
14.3 Purified and Water for Injection Systems……… 16
14.4 Depack / Preparation component room……….. 19
14.5 Sterilizer / Oven Loading Room ……… 20
14.6 Equipment Airlock…….. 21
14.7 Washroom / Grown change room……… 22
14.8 Manufacturing (Sterile Product) ……….. 23
14.9 Aspectic Batching Area………. 25
14.11 Filling room………. 27
14.14 Terminal Sterilization………. 30
14.15 Packaging……….. 31
14.16 Manufacturing (Oral dosages) ……… 32
14.17 Packaging… 34
15. Reprocessing ……… 35
16. Finished Product Control…….. 35
17. Warehouse / Distribution……… 36
18. Environment, Health & Safety 37

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 GOOD MANUFACTURING PRACTICE (GMP AUDIT- CHECK LIST)
(FOR PHARMACETICAL MANUFACTURING FACILITIES)

Yes No Not RATING REMARKS

SR # CRITERIAS Applicable (1-10)
(1=low 10=high)
(To be filled by To be filled by
(To be filled by Auditee) Auditor) Auditor

1.0 QUALITY ASSURANCE

1.1 Does the company have mission statement and the quality
policy?
1.2 Is the company ISO certified?
1.3 Was the company previously audited (GMP audit)?
1.4 Are pharmaceutical products designed and developed according
to the requirement of GMP & other associated codes such as
good laboratory practice (GLP) and good clinical practice
(GCP)?
1.5 Are production and control operations clearly specified in a
written form and GMP requirements are adopted?
1.6 Are managerial responsibilities clearly specified in job
descriptions?
1.7 Are all necessary controls on starting materials, intermediate
products and other in-process controls, calibrations and
validation carried out?
1.8 Are finished products correctly processed and checked according
to the defined procedures?
1.9 Are satisfactory arrangements existed to store in appropriate
storage conditions?

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2.0 PREMESIS
(DESIGN & LAYOUT OF FACILITIES)
2.1 Does the facility have proper design, layout and finishes based on
contemporary standards to:

2.1.1 Manufacture high quality medicine.

2.1.2 Avoidance of cross contamination.
2.1.3 Proper cleaning, drainage and sanitizing.
2.1.4 Ventilation, air conditioning and maintenance.

2.2 Is there emergency power supply available to take care of entire

energy demand or at least critical areas?

2.3 Does the facility have appropriate controls to maintain required

parameters e.g. temperature, relative humidity and pressure
differentials etc?

2.4 Are the doors, windows, walls, ceiling and floor such that no
holes or cracks evident (other than those intended by design)?

2.5 PLANT SAFETY & SECURITY

2.5.1 Does the facility have safety program?
2.5.2 Are safety procedures written?
2.5.3 Do employees receive safety orientation before working in the
plant area?
2.5.4 Does the facility have a formal, written security policy?
2.5.5 Is access to the facility restricted?

2.6 SANITATION
2.6.1 Is written sanitation program available on the premises?
2.6.2 Is sanitation program is implemented and effective in preventing
conditions?

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3.0 PERSONNEL (STAFFING PLAN, STAFF QUALIFICATION,
EXPERIENCE , ON THE JOB TRAINING & HYGIENE)

3.1 Has the facility provided sufficient qualified personnel to fulfill

all its responsibilities required under the rule?
3.2 Has the facility provided Organization Chart?

3.3 Does the company have qualified, trained and experience staff
required for managing?

3.4 Does the company have “On the job training program” for
technical staff?

3.5 Is the technical staff, including supervisors and operations

certified (and documented) in specialized training e.g. aseptic
technique, sterilizing, washing, depyrogenation, visual
inspection, standard operating procedure etc.

3.6 HYGIENE

3.6.1 Are all the personal under gone health examination to prior to
employment?
3.6.2 Are all the personnel provided health examination during
employment?
3.6.3 Are workers conducting visual inspections under gone periodic
eye examination?
3.6.4 Are the record maintained?
3.6.5 Are all personal aware about of the principles of GMP and
received initial and continued training including hygiene
instructions?

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4.0 VALIDATION

4.1 Is validation properly documented and include Validation Master

Plan, Validation Protocols, Validation Reports and Equipment
Qualified?
4.2 Are validation studies conducted in accordance with pre-defined
protocols?
4.3 Have production procedures been validated?
4.4 Does the process control address an issue to ensure identity,
strength, quality and purity of product?
4.5 Does the procedure include formulation that is written to yield
not less than 100% of established amount of active ingredients?
4.6 Are all weighing and measuring performed by one qualified
person and observed by a second person and is dully signed by
both of them on record sheet?

4.7 Validation of New Master Formula:

Is new master formula or method of preparation adopted and
steps taken to demonstrate its suitability for routine processing,
process defined materials and equipment specified?

4.8 Validation of Equipment & Materials:

Are significant amendments to the manufacturing process,
including any change in equipment and materials affecting
product quality or re-productivity of process validated?

4.9 Are validation records properly maintained?

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6.0 VENDOR QUALIFICATION

6.1 Do you have list of approved vendors?

6.2 Are the vendors supplying raw material (both active & inactive
ingredients), empty gelatin capsules, primary packaging & printed
packaging components audited & found to be satisfactory?

7 CHANGE CONTROL PROGRAM

7.1 Is there a formal change control program in place supported by an

SOP to initiate, review & approve changes in material, sources,
processes, products packaging, equipment, batch size changes etc.

8.0 SAMPLE

8.1 Does the company retain a sample of lot or batch of the packaged /
labeled drug for a period of at least one year after the expiration
date on the label of the drug?

8.2 Does the company retain a sample of each lot or batch of a raw
material (including both active and inactive ingredients)?

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9.0 STABILITY STUDIES

9.1 Does the company have a prospective and concurrent stability

studies program based on SOP and utilizing proper equipment i.e.
climatic chambers maintained at 30° C / 65% RH for ambient and
40° C / 75% RH for stress conditions and continuously monitored
for temperature & RH?

9.2 Is stability of finished products evaluated and documented prior to

marketing?

9.3 Does the stability data support shelf life assigned to the product.
Are any deviations in data reviewed and appropriate steps taken in
case of stability issues?

10.0 DRUG RECALL

10.1 Do you have SOP for drug recalls?

10.2 If answer yes to the above did you have any drug recall in the past
2 year? (Please also mention the name of products)

11.0 ANNUAL PRODUCT REVIEW

11.1 Is there a process in place to review statistical data (i.e.: trend

analysis, reworks, rejects, customer complaints) of all the products
manufacture during the year?

11.2 Provide name of the products manufactured by you along with

price list.

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11.3 Provide the source of raw material for individual products.

11.4 Do you export your products, if so then to whom and mention the
name of the products?

12.0 AUDIT / COMPLAINTS

12.1 INTERNAL GMP AUDITS

12.1.1 Do you have an effective internal GMP inspection program to

audit all the manufacturing areas, activities & QC lab at specific
defined periods?

12.1.2 Is there a process in place to fill the gaps / observation / non-

conformance found during the internal GMP audits?

12.2 QUALITY AUDITS

Is quality audit conducted by outside or independent specials or a
team designated by the management for the purpose?

12.3 COMPLAINTS
Are complaints and other information concerning potentially
defective products carefully reviewed according to the written
procedures?

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13.0 QUALITY CONTROL DEPARTMENT

13.1 Does the QC lab have SOPs to cover all the functional areas?

13.2 Are adequate facilities and equipments available for the physical,
chemical & microbiological testing?

13.3 Are approved written procedures available for sampling,

inspecting and testing raw materials, packaging materials, in
process drugs, bulk drugs and finished products?

13.4 Are samples of starting material, packaging material,

intermediate products, bulk products and finished products taken
by methods and personnels approved by QC department?

13.5 Are in-process materials tested at appropriate phases for identity,

strength, quality, purity and are they approved or rejected by
Quality Control?

13.6 Are records of in- process controls maintained?

13.7 Does each batch of drug product prior to release confirms

compliance of finished product specification?

13.8 Are validated & stability indicating assay methods used?

13.9 Are reference standards used for the assay?

13.10 Are accurate, clear & neat records maintained along with the raw
data for the entire analytical work?

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 14.0 MANUFACTURING AREA
EQUIPMENTS, MATERIAL / COMPONENT

14.1 EQUIPMENTS

14.1.1 Does the company have suitable equipments capable of

producing consistent quality products?

14.1.2 Do the equipments meet contemporary standards for the

manufacture of pharmaceuticals i.e. smooth finishes, right
quality construction material for the intended purpose, easy to
clean, wash, sterilize etc.

14.1.3 Are the following pieces of equipments suitable in their

design/size & capacity? (Blendes, Conveyors, Tablet presses,
Capsule fillers, Bottle fillers etc)

14.1.4 Does the equipments & facilities have appropriate controls to

maintain required parameters e.g. temperature, relative
humidity, pressure differentials etc?

14.1.5 Is the equipment cleaned promptly after use?

14.1.6 EQUIPMENT/INSTRUMENTS CALIBRATION &

PREVENTIVE MAINTENANCE

14.1.6.1 Are written records maintained on equipment cleaning,

sanitizing and maintenance on or near each piece of equipment?

14.1.6.2 Does the facility have approved written procedures for checking
and calibration of each piece of measurement equipment?

14.1.6.3 Are records of calibration checks and inspections maintained in

a readily retire able manner?

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14.1.7 MATERIAL/COMPONENT

14.1.7. All handling of material and products such as receipt, quarantine,

1 sample storage, tracking, labeling, dispensing, processing,
packaging and distribution is done in accordance with approved
written procedure, or instruction and recorded?

All incoming materials and finished products quarantined

14.1.7. immediately after receipt or processing until they released for use
2 or distribution?

Are all materials handled in such a way to prevent

contamination?
14.1.7.
3 RAW MATERIAL

Were the premises designed for storing the raw material?

14.2
Does the store premises allow storage of raw materials at various
14.2.1 temperatures?

14.2.2 If answer yes to the above what are the controls to log any
irregularities?

14.2.3 What is the source of the active ingredient used?

What are the source of additives used?

14.2.4
Is any documentation done at the time of receiving the raw
14.2.5 materials?

14.2.6 What is the process of communication with the laboratory for

sampling of the raw material?
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 Is there a quarantine for storing unreleased raw materials?
14.2.7
If so, what is the process?
14.2.8
What is the process of storage after the raw material is released
14.2.9 for use?

14.2.10 What is the process of issue of raw material for manufacturing?

Who is responsible of issuing?

14.2.11
What is the process of revalidation of balances?
14.2.12
What is the process of revalidation of raw materials?
14.2.13
Do you have a standard operational procedural manual for
14.2.14 stores?

14.2.15

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14.3 PURIFIED AND WATER FOR INJECTION SYSTEM
Does the facility have proper Purified and Water for Injection
14.3.1 System available?
Is water circulating in a continuous loop and maintained at 80° C,
24/07/365?
Is quality of water monitored chemically & biologically on daily
basis?
14.3.2 Is purified water used in all oral preparation & washing of
equipment?
14.3.3 Is water for injection used for all sterile preparation, clean steam
generation for autoclaving, final rinse of machine parts and
sterile container?
14.3.4 Are deionizers that feed water for injection of two bed design and
able to provide for continous flow?
14.3.5 Are stills constructed of stainless steel?
14.3.6 If yes what type?
14.3.7 Are still equipped with devices which measure, record and
automatically control conductivity
14.3.8 Have the stills been passivated?
14.3.9 Are the holding tanks electropolished and passivated?
14.3.1 Are the holding tanks electro polished and passivated?
0 Are the holding tanks equipped with heated or jacketed 0.2
14.3.1 micron hydrophobic filter?
1 Are the holding tanks capable of steam sterilization at a
minimum of 121° C?
14.3.1 Are holding tanks equipped tanks equipped to maintain WFI at
2 80 °C?
Are the holding tanks equipped to supply nitrogen through a 0.2
14.3.1 micron hydrophobic vent filter?
3 If WFI system constructed of stainless steel 316 L or equivalent?
Is WFI system electro polished and passivated?
14.3.1 Is there a continous loop, single pass system?
4 Is the system sloped with dead legs no larger than 6 pipe
diameters?
14.3.8 Is the system fitted with diaphragm values ?
14.3.9 Is the system capable of steam sterilization?
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14.3.1 Is the system capable of being maintained at 80 °C with
0 continous temperature monitoring devices?
14.3.1 Is the conductivity of WFI monitored on return loop?
1 Are pumps constructed of stainless steel, 316 L or equivalent?
Do the pumps use WFI as seal lubricant?
14.3.1 Are pumps able to be completely drained?
2 What is the source of water to the facility?
14.3.1 Well / City water / Treated / Untreated
3 Is testing performed on dionized water system which supplies the
14.3.1 NFI system?
4 What tests are performed?
How frequently are they performed?
14.3.1 Are the results documented?
5 Are there heat exchangers with in WFI system?
14.3.1 What is the type of heat exchangers 316 L / Double sheet type/
6 double concentric tube type?
14.3.1 What is the type and porosity of filters within WFI system?
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14.3.1 Which department performs the validation of WFI system?
8
14.3.1 Was the validation approved by QC/QA?
9 Was the report issued and forwarded to world wide QC/QA?
Do you have SOP written for WFI?
14.3.2 Is WFI tested when used as raw material as per testing standard Z
0 5576 requirements?
Are the results documented?
14.3.2 Are the all use points in WFI system tested as per testing
1 standard Z 5576 on weekly basis?
14.3.2 Are the results documented?
2 Have microbial limits been established for WFI samples?
14.3.2 What action plan exists in the event the microbial limits exceed?
3 Are the investigation documented?
14.3.2 What is the porosity of membrances used in microbiological
4 testing?
14.3.2 What nutrient media is used?
5

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14.3.2
6

14.3.2
7

14.3.2
8
14.3.2
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14.3.3
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14.3.3
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14.3.3
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14.3.3
3

14.3.3
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14.3.3
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14.3.3
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14.3.3
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14.3.3
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14.3.3
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14.3.40 At what temperature and for how long are WFI samples
incubated?

14.3.41 After incubation how are results documented?

14.3.42 Are any micro organisms that are isolated from positive WFI
samples gram stained and/or identified to genus / species?3
14.3.43 Are standardized and validated autoclave loads for nutrient media
used for WFI testing?
14.3.44 Are growth support testes performed on each lot of nutrient media
that is used for WFI testing?
14.3.45 How is sterility verified for each lot of nutrient media that is used
for WFI testing?

14.3.46 How is nutrient media stored prior to use?

14.3.47 Are there established routine maintenance / calibration programs

for deionized and WFI systems?

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 14.4 DEPACK / PREPARATION COMPONENT ROOM

14.4.1 Is the depack room separate from the component preparation

room?

14.4.2 Does depack room have air conditioning and local exhaust for
dust control?

14.4.3 Is there a pass through between the depack room and the
component preparation room?

14.4.4 Is there a uniform change room outside of the preparation

component room?

14.4.5 Is access to the preparation component room restricted?

14.4.6 What is the preparation component room designated class?

a. What is the efficiency of filters? __________ %
b. How many air changes occur per hour?
14.4.7 What type of water is supplied to washer and sinks?

14.4.8 What is the validation process for the washing of stopper & vials?

14.4.9 How are the silicone vials and stopper tested for use?

14.4.10 Are Stopper and vials tagged with lot numbers as such through
sterilization/depyrogenation and on through filling

14.4.11 How frequently are efficiency filters and laminar flow hood heap
filters tested?

14.4.12 Are the garments made of non-shredding material?

14.4.13 What is the frequency of the garments being sterilized?

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 14.5 STERILIZER / OVEN LOADING ROOM

14.5.1 What is the sterilizer / oven loading room designated class?

14.5.2 What is the efficiency of filters?

14.5.3 How many air changes occur per hour?

14.5.4 Does the sterilizer meet the following criteria:

a. Is it capable of maintaining an empty chamber temperature
distribution of +/- 1° C at a steady state?
b. Is there a double door design with interlock?
c. What is the size of vent filter?
d. Is it capable of using thermocouples in the chamber for
measuring load temperatures?
e. Is it equipped with a recording device for checking
temperature and pressure?
f. Is it equipped with a vacuum pump for the removal of air
from the load?
g. Is it equipped with a clean steam?

14.5.5 Does the oven meet the following criteria?

a. Is it equipped with hepa filtered air?
b. Are there 2 inter locking doors?
c. Are there recirculating fans located upstream of the Hepa
filters?
d. Does it have the resistance temperature device in the return
air duct for control temperature?
e. Can it maintain an empty chamber temperature distribution
of +/- 25 °C at 300 °C when utilized for depyrogeration and
at a 90 °C +/- 20 °C for sterilization?
f. Is it equipped with a temperature recorder?
g. Can be fitted with additional temperature probes for
measuring loaded materials?

14.5.6 How frequently are the sterilizer and oven calibrated and the
results documented?
14.5.7 How frequently are the efficiency filters integrity tested?
14.5.8 Are the results of the testing documents?
14.5.9 Are the garments made of non sharedding material?
14.5.10 Are the garments washed and sterilized after use? 19
14.5.11 How frequently are they sterilized?
14.5.12 Are the procedures validated for the sterilized/depyrogenated
14.8 MANUFACTURING
(STERILE PRODUCTS)

14.8. Does the company have adequate sterilizing, deprogenating,

1 sterile, filteration, processing, filling and packaging equipment
available?

Is there an adequate control of viable, non-viable micro-organisms

14.8. and effective routine monitoring of sterile area and aseptic
2 practices through use of reliable equipment?

Are sterile area air handling unit run 24/7 except for shut down
due to routine maintenance to maintain sterile environment?
14.8.
3
ENVIRONMENTAL MONITORING
Are laminar flow hood and HVAC system which serve the sterile
operations areas validated?
14.9 Which department performs the validation?
14.9.
1 Was the validation approved by QC/QA?
Was the report issued?
14.9. If yes, was the report forwarded to worldwide QC/QA?
2 Is there an environmental monitoring program for the aseptic
batching area, sterile filling room, sterile filling line and ancillary
14.9. areas?
3
14.9. Is non viable particulate sampling performed?
4
14.9. How is viable air sampling performed?
5
How is surface sampling performed?

Is environmental monitoring equipment on a maintenance /

calibration program?
14.9.
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 6

14.9.
7

14.9.
8

14.9.
9

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14.9.1 At what temperature for how long are environmental monitoring
0 samples incubated?

After incubation how are test results documented?

14.9.1
1 What nutrient media is used for environmental monitoring?

14.9.1 Are there standardized and validated autoclave loads for nutrient
2 media used for environmental monitoring?

14.9.1 Are growth support tests performed on each lot of nutrient media
3 that is used for environmental monitoring?

How is sterility verified for each lot of nutrient media that is used
14.9.1 for environmental monitoring?
4
How is nutrient media stored prior to use?

14.9.1
5

14.9.1
6

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14.10 ASCEPTIC BATCHING AREA

14.10.1 Is the area designated as class 10,000?

14.10.2 Are there terminal Hepa filters?

14.10.3 What is the minimum of air changes per hour?

14.10.4 Is the area capable of complying with the maximum temperature

(68° F) and humidity limits (50% RH)?

14.10.5 Do the laminar flow hoods provide class 100 air over the product?

14.10.6 Is all the product contact equipment in the aseptic batching area
sterilizable by hot air or steam?

14.10.7 Are the walls, floors and ceilings non porous and sanitizable?

14.10.8 Are the doors self closing without door knobs?

14.10.9 Are the light fixtures and motors totally sealed and enclosed?

14.10.1 Are the room air pressure, temperature, humidity and filter
0 pressure drop automatically monitored, alarmed and recorded?

Do personnel sanitize their gloved hands?

14.10.1
1 Are Hepa filters and laminar flow hoods integrity tested?

14.10.1 If yes, how frequently?

2
Are equipment status labeled?
14.10.1
3 Are the results documented for the equipments calibrated?
Are sterilization/clarification filters integrity tested and results
14.10.1 documented
4 What is the quality of water used for equipment cleaning?
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 14.11 FILLING ROOMS

14.11.1 Is the filling room designated as class 10,000?

14.11.2 What are the minimum air changes per hour

14.11.3 Are environmental systems designed to run continuously?

14.11.4 Is the area capable of complying with maximum temperature (68

°F) and humidity limits (50%RH)?
14.11.5 Do this laminar flow hoods provide class 100 air over product?
Is the product contact equipment sterilize by hot air or steam?

14.11.6 Are the walls, floors and ceilings non-porous and sanitizable ?

14.11.7 Are the doors self closing without door knobs?

14.11.8 Are the light fixtures and motors totally sealed and enclosed?

14.11.9 Are room air pressure, temperature, humidity and filter pressure
drop automatically monitored, alarmed and recorded?
14.11.10 Are the filling lines designed with laminar flow hoods to provide
class 100 air at the rate of 90feet/minute at the product height?
14.11.11
Are surfaces of laminar flow hood made of stainless steel?
14.11.12
14.11.13 Is the filling line equipped with continous non-hinged, non-
shedding sanitizable belt or conveyor system?

14.11.14 Is the filling line equipped with automatic filling and stoppering
equipment?
14.11.15 What sanitizing agent is used to sanitize gloved hands?

14.11.16 Are Hepa filters and laminar flow hoods integrity tested?
If yes, how frequently?

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14.11.17 How is the product delivered from aseptic batching area to the
filling lines?

14.11.18 Is the sterile bulk filtered on line?

14.11.19 Is the sterile filter integrity tested before and/or after use?

14.11.20 Is the porosity and type of filter included with the batch records?

14.11.21 Are results of filter integrity test included with the batch records?

14.11.22 Is bulk held under positive pressure during filling operation?

14.11.23 How are gases sterilized?

14.11.24 Are asceptic operations performed using laminar flow hoods?

14.11.25 How is the filling figure determined?

14.11.26 Is the fill volume checked during filling operation?

14.11.27 Are the results documented?

14.11.28 What action is taken when filling limits are exceeded?

14.11.29 Are vials flooded with nitrogen?

14.11.30 Where are the vials capped?

14.11.31 Are rejected vials reprocessed?
14.11.32 If so what are the written procedures?

14.11.33 Is QC/QA informed of manufacturing problems that could affect

product quality? (Alert Notice System).

14.11.34 What is the quality of water used for equipment cleaning?

14.11.35 What filling equipment parts are sterilized /depyrogenated inan
autoclave oven prior to use?
14.11.36 Have these processes been validated?
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14.11.37 How frequently are the filling line (including accessories)
sanitzed?
14.11.38 What sanitization agents are used?

14.11.39 Are the procedures validated and documented?

14.11.40 Is a filling line use record kept?

14.12 SANITIZATION OF STERILE ROOMS

14.12.1 How frequently is the sterile area sanitized?

14.12.2 What areas are sanitized?

Floor / Wall / Ceilings

14.12.3 What sanitizing agents are used?

14.12.4 Are sanitizing agents rotated?

14.12.5 Are sanitizing agents prepared with WFI and filter sterilized prior
to use?

14.12.6 How is it applied to surfaces?

14.12.7 Is sanitization agent allowed to dry and then rinsed off with WFI?

14.12.8 Is sanitization documented?

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 14.13 INSPECTION

14.13.1 Are filled vials inspected for particulars and container defects
prior to packing?
What percentage of batch is inspected?
14.13.2
Are the types of rejected vials documented?
14.13.3
14.13.4 Are rejected vials reprocessed?

14.13.5 Is there a written procedure for handling rejected vials?

.14.13.6 Are inspectors trained?

14.13.7 Is the training documented?

14.13.8 Do inspectors receive an eye examination?

14.13.9 If yes, how frequently?

14.14 TERMINAL STERILIZATION

14.14.1 Are any products terminally sterilized?

14.14.2 Are these processes validated?

14.14.3 Is each sterilization cycle recorded on a time-temperature chart?

14.14.4 Are biological indicators used in sterilization process?

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 14.15 PACKAGING
14.15.1 Is the packaging line equipped with capping equipment?

14.15.2 If so then with semi-automatic or automatic?

14.15.3 Are line, clearances performed and documented?

14.15.4 Is there adequate packing indicating status of product?

14.15.5 Is the line labeled during packing indicating status of product?

Are QC inspectors checking and documenting the packaging

14.15.6 operations?

14.15.7 Are rejected vials reprocessed?

14.15.8 Are the number of packaged containers reconciled with the

amount of filled containers that were delivered for packaging?

14.15.9 Is the reconciliation documented?

14.15.1 Upon completion of packaging, are the labels, inserts and cartons
0 reconciled?

Is QC/QA informed in writing of manufacturing problems that

14.15.1 could affect product quality?
1
How frequently is the area cleaned / sanitized?

14.15.1
2

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 14.16 MANUFACTURING
(ORAL DOSAGE FORM)
14.16.1 What is the receiving process of raw material from the stores?

14.16.2 Where is the raw material stored after being issued from the
stores?

14.16.3 Does the QC validate the water used during the manufacturing
process?

14.16.4 What is the source of water?

14.16.5 What are the SOP for the dryers used?

14.16.6 What are the controls for the temperature logging of the dryers?

14.16.7 What are SOP to eradicate cross contamination?

14.16.8 What procedures are adopted for storing of granules checked by

QC for releasing the batch for compression?

14.16.9 Are the granules checked by QC for releasing the batch for
compression?

14.16.10 During compression what are the SOP followed?

14.16.11 How frequent does QC inspector verifies the compression

process?

14.16.12 How many compression machines are handled by one operator?

14.16.13 If answer to above is more than one what precautions are in force
to avoid cross contamination between different products?

14.16.14 How are the compressed tablets stored before the batch is released
for packaging?
29
14.16.1 Are there temperature log sheets maintain during the
5 manufacturing cycle?

What safety measures are adopted for the personnel working in

14.16.1 manufacturing?
6
Do you manufacture capsule dosage form

14.16.1 What types of humidifiers are used at the point of capsule

7 filling?

14.16.1 Is filling done on an automatic, semi-automatic or manual

8 machine?

How is the polishing of filled capsules done?

14.16.1
9 What are the SOP for liquid manufacturing?

What is the process of bottle washing?

14.16.2
0 What is the type of water used in bottle washing?

14.16.2 How is the batch released by QC?

1
How are the stainless steel tanks washed after completion of a
14.16.2 product?
2
Check on yields and reconciliation of quantities are carried out
14.16.2 at appropriate stages of the process to ensure that yields are
3 within acceptable limits.

14.16.2 Are the deviations from the expected yield are recorded and
4 investigated?

14.16.2
5
30
 PACKAGING
14.16.2
6 What is the glass type of the bottles used?

What are SOP for

a. Packaging Materials
14.16.2 b. Packaging Operation
7 c. Labels and Labeling

How frequent does the QC inspector visits the packaging area?

Is the integrity of the batch maintained during the packaging

process?
14.17

14.17.1 Is there SOP for packaging Material?

14.17.2 Is there SOP for Packaging Operations?

14.17.3 Is there SOP for Labels & Labeling?

All products and packaging materials to be used are checked on

14.17.4 receipt by the packaging department for quality, identity and
conformity with the packaging instructions?
14.17.5
The name and batch number of the product being handled is
displayed at each packaging station or line?

14.17.6

14.17.7

14.17.8

14.17.9

31
14.17.1
0

32
15.0 REPROCESSING

15.1 Do written procedures identify steps for reprocessing batches?

15.2 Does QC testing confirms that reprocessed batches conforms to

established specification?

16.0 FINISHED PRODUCT CONTROL

16.1 Do written procedures indicate how and who verifies that correct
containers and packages are used for finished product during there
finishing operation?

16.2 Has the formulation of each product been tested for stability based
on a written protocol?

16.3 Are written sampling and testing procedures and acceptance

criteria available for each product to ensure conformance to
finished product specification?

33
17.0 WAREHOUSING / DISTRIBUTION

17.1 Are material stored under conditions as per the storage

instructions on the label?

17.2 Is there adequate space for the orderly storage of material?

17.3 Is there a segregation of quarantined, approved & rejected

materials?

17.4 Are there separate stores for raw material, packaging material,
labels and finished products?

17.5 Are materials stored on pallets, shelves, or racks, off the floor and
off the walls in all stores?

17.6 Are minimum and maximum temperatures in the store recorded?

17.7 Are air-conditioned and cold room facilities available?

17.8 Are flammable and hazardous chemicals stored in safe

conditions?

17.9 Are there no expired raw materials in the raw material store(s)?

17.10 Are materials dispensed according to prescribed SOP meeting

GMP requirements?

17.11 After release by quality control, are raw materials and packaging
materials released on a FIFO (first in first out) basis?

17.12 Do distribution records in the finished good store enable specific

batches to be traced?

34
18.0 ENVIRONMENT, HEALTH & SAFETY

18.1 Does the company monitor and maintain incident / accident data
etc to create awareness and develop improvement plans?

18.2. Does the company industrial hygiene sampling / monitoring

program, do the employees use appropriate personnel protective
equipment?

18.3 Does the company have fire fighting facility having fire hydrants,
sprinkler system & trained people to handle the emergency?

18.4 Does the company have a proper hazardous and non-hazardous

material storage and disposal system? (E.g. explosion proof
cabinets & manufacturing suites, flammable storage area, solid
waste incineration and waste water treatment)?

18.5 Are drains and routine cleaning procedures sufficient to prevent

standing water inside the facility?

18.6 Is lighting adequate in all areas?

18.7 Is the control of air pressure, dust humidity and temperature

adequate for the manufacturing, processing storage or testing of
the drug products?
18.8 If air filters are used is there a written procedure specifying the
frequencies of inspection and replacement?

35
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