Chapter # 1-Personnel |
|||||||
Sr
# |
Parameters to be Inspected |
Compliance |
Non
Conformance |
Auditors
Comments |
|||
Y |
N |
NA |
Major |
Minor |
|||
1. |
Does up-dated organization chart (Organogram of the
organization) available? |
|
|
|
|
|
|
Does up dated technical staff list available? |
|
||||||
2. |
Does Production and QA/ QC functions independent of
each other? |
|
|
|
|
|
|
3. |
Does all unit areas adequately staffed? |
|
|
|
|
|
|
4. |
Does there proper supervision in every department? |
|
|
|
|
|
|
5. |
Does hiring of an employee proceeded by a medical
examination? |
|
|
|
|
|
|
6. |
Does this examination done periodically? |
|
|
|
|
|
|
Who is responsible for reporting/checking health of
employee? |
|
|
|
|
|
|
|
7. |
Does there any system of reporting back after
illness? |
|
|
|
|
|
|
8. |
Does medical assistance available during the normal
working hours? |
|
|
|
|
|
|
9. |
Does there suitable washing, changing and rest
areas? |
|
|
|
|
|
|
10. |
Does clothing suitable for the activity undertaken? |
|
|
|
|
|
|
11. |
Does clear instructions provided on usage and change
of protective clothing? |
|
|
|
|
|
|
12. |
Does in-house laundry used? |
|
|
|
|
|
|
13. |
Have all personnel received GMP training? |
|
|
|
|
|
|
14. |
Does training manual/syllabus of GMP available and
enclosed? |
|
|
|
|
|
|
15. |
Does record of training available and enclosed? |
|
|
|
|
|
|
16. |
Does efficacy of training assessed by questionnaire? |
|
|
|
|
|
|
Chapter # 2-Premises |
|||||||
Sr # |
Parameters to be
Inspected |
Compliance |
Non Conformance |
Auditors Comments |
|||
Y |
N |
NA |
Major |
Minor |
|||
1. |
Does there any source of
pollution (industrial or other) in the neighborhood of the building? |
|
|
|
|
|
|
2. |
Does well-labeled plant lay-out
of suitable size, design and construction for each areas of production and
Quality control available? |
|
|||||
3. |
Does the plant so constructed
and maintained to protect against. a) Weather, flood,
ground seepage? b) Access and harboring of
vermin, rodents, birds, insects and other animals? |
|
|
|
|
|
|
4. |
Does there an adequate working
space for a) Orderly and logical placement
of equipment and materials? b) Efficient flow of work? c) Effective communication? |
|
|
|
|
|
|
5. |
Does buildings and facilities
properly constructed to facilitate smooth operation and adequate cleaning? |
|
|
|
|
|
|
6. |
Does room arrangements and the
air supply adequate, to prevent mix-up or cross-contamination of products? |
|
|
|
|
|
|
7. |
Does the environment of
processing areas monitored and controlled to the degree required for the
operation performed? |
|
|
|
|
|
|
8. |
Does effective air extraction
system in the dust producing locations and equipment installed with discharge
points situated to avoid contamination? |
|
|
|
|
|
|
Chapter # 3-Equipments |
|||||||
Sr
# |
Parameters to be Inspected |
Compliance |
Non
Conformance |
Auditors
Comments |
|||
Y |
N |
NA |
Major |
Minor |
|||
1. |
Does major production and QC equipment list available? |
|
|
|
|
|
|
2. |
Does all the equipment are qualified or calibrated? |
|
|
|
|
|
|
3. |
Does the material of equipment surfaces coming into
contact with product inert? |
|
|
|
|
|
|
4. |
Does the equipment properly maintained and easily cleaned? |
|
|
|
|
|
|
5. |
Does the equipment identified as to its status (cleaned,
to be cleaned, batch controls)? |
|
|
|
|
|
|
6. |
Does SOP for equipments cleaning, sanitizing and
maintenance of available & recorded in logbook of equipment cleaning? |
|
|
|
|
|
|
7. |
Does all equipments holding inprocess products properly
labeled and quarantined until approved and released by quality control unit
so as to identify the stage of processing? |
|
|
|
|
|
|
8. |
Does all equipments properly grounded where required? |
|
|
|
|
|
|
9. |
Does there any program for calibration of equipments &
calibration documented? |
|
|
|
|
|
|
10. |
Does major equipment clearly marked with identifying
numbers? |
|
|
|
|
|
|
11. |
Does qualification, validation and calibration programs
available for equipment used for production, quality control heating
ventilation, air conditioning (HVAC), water system, steam, compressed air,
gasses etc.? |
|
|
|
|
|
|
Chapter # 4-Sanitation & Hygiene |
|||||||
Sr
# |
Parameters to be Inspected |
Compliance |
Non
Conformance |
Auditors
Comments |
|||
Y |
N |
NA |
Major |
Minor |
|||
1. |
Does high level of sanitation & hygiene applied in manufacturing
of drug product? |
||||||
2. |
Does protective measures taken to assure protection of
product from contamination as well as the safety of personnel? |
|
|
|
|
|
|
3. |
Does there any regulation for personnel entering the
building and facility designated as limited access area? |
|
|
|
|
|
|
4. |
Does smoking, eating, drinking, restricted in production,
QC lab & storage areas? |
|
|
|
|
|
|
5. |
Does employee's washing and toilet facilities adequate and
in sufficient quantity? |
|
|
|
|
|
|
6. |
Does procedure of qualification and validation of
sanitation and hygiene available? |
||||||
7. |
Does there any program for control of pest, rodents,
insects or birds? |
|
|
|
|
|
|
8. |
Does the program appropriately designed so that the
rodenticides, insecticides, fumigating agents and sanitizing material do not
contaminate equipment, raw materials, packaging materials, in-process
materials or finished products? |
|
|
|
|
|
|
9. |
Does cleaning agents and method monitored routinely by
chemical and or microbiological method? |
|
|
|
|
|
|
10. |
What are the cleaning methods/frequency for the water
supply system, air handling system and dust extraction system? |
|
|
|
|
|
|
11. |
Does the wash room equipped with sink and hot air hand
drivers? |
|
|
|
|
|
|
12. |
Does the wash room have lights? |
|
|
|
|
|
|
13. |
Does the wash room have interlocked doors? |
|
|
|
|
|
|
Chapter # 5-Water System |
|||||||
Sr
# |
Parameters to be Inspected |
Compliance |
Non
Conformance |
Auditors
Comments |
|||
Y |
N |
NA |
Major |
Minor |
|||
1. |
Does the facility have proper Water System Plant
available? |
||||||
2. |
Does water circulating in a continuous loop |
|
|
|
|
|
|
3. |
Does purified water used in all oral preparation
& washing of equipment? |
|
|
|
|
|
|
4. |
Does Purified water used for autoclaving, final rinse
of machine parts and sterile container? |
|
|
|
|
|
|
5. |
Does still equipped with devices which automatically
measures conductivity? |
|
|
|
|
|
|
6. |
Does
the holding tanks electro-polished and passivated? |
|
|
|
|
|
|
7. |
Does the holding tanks equipped with heated/jacketed
0.2µ hydrophobic filter? |
|
|
|
|
|
|
8. |
What
is the source of water to the facility? |
|
|
|
|
|
|
9. |
Does testing performed on purified water system? |
|
|
|
|
|
|
10. |
What
tests are performed & what is the frequency of tests |
|
|
|
|
|
|
11. |
Does
the results documented? |
|
|
|
|
|
|
12. |
Which
department performs the validation of water system? |
|
|
|
|
|
|
13. |
Was
the validation approved by QC/QA and documented? |
|
|
|
|
|
|
14. |
Does
the SOP for water sampling & testing available? |
|
|
|
|
|
|
15. |
Have
microbial limits been established for water samples? |
|
|
|
|
|
|
16. |
Does there any system for CAPA exists for OOS
results and documented? |
|
|
|
|
|
|
17. |
What
is the porosity of membranes used in microbiological testing? |
|
|
|
|
|
|
18. |
What
nutrient media is used? |
|
|
|
|
|
|
19. |
At
what temperature and for how long are water samples incubated? |
|
|
|
|
|
|
20. |
After
incubation how the results does documented? |
|
|
|
|
|
|
21. |
How
is nutrient media stored prior to use? |
|
|
|
|
|
|
Chapter # 6-Dry Heat Sterilization |
|||||||
Sr
# |
Parameters to be Inspected |
Compliance |
Non
Conformance |
Auditors
Comments |
|||
Y |
N |
NA |
Major |
Minor |
|||
1. |
Does
the decartoning room separate from the vial washing area? |
||||||
2. |
Does decartoning room have proper HVAC system for
dust control? |
|
|
|
|
|
|
3. |
What type of water is supplied to washer and sinks? |
|
|
|
|
|
|
4. |
What is the SOP for the washing of stopper &
vials? |
|
|
|
|
|
|
5. |
How does the vials and stopper tested for use? |
|
|
|
|
|
|
6. |
What is the sterilizer / oven loading room
designated class? |
|
|
|
|
|
|
7. |
Does the sterilizer double door with interlock? |
|
|
|
|
|
|
8. |
What is the
size of vent filter? |
|
|
|
|
|
|
9. |
Does it capable of using thermocouples for measuring
load temperatures? |
|
|
|
|
|
|
10. |
Does it equipped with a recording device for checking
temperature? |
|
|
|
|
|
|
11. |
Does it capable of maintaining temperature distribution
of 250°C± 2oC for 1hr for depyrogeration and at a 180°C± 2°C for
2hrs for sterilization? |
|
|
|
|
|
|
12. |
How frequently is the oven calibrated and the
results documented? |
|
|
|
|
|
|
13. |
Does SOP for storage of sterilized or depyrogenated
items available? |
|
|
|
|
|
|
14. |
Does process for storage of sterilized or
depyrogenated items validated? |
|
|
|
|
|
|
15. |
What cleaning/sanitizing agent used for cleaning of
dry heat sterilizer |
|
|
|
|
|
|
16. |
Have restrictions been established for the number of
times that components may be sterilized /depyrogenated? |
|
|
|
|
|
|
17. |
Does it equipped with HEPA filter? & what
is the efficiency of the filter? |
|
|
|
|
|
|
18. |
Does
there recirculating fans located
upstream of the HEPA filters? |
|
|
|
|
|
|
Chapter # 7-Manufacturing of Dry Powder for
Injection (Premises, Area,
Design & Layout) |
|||||||||||||
Sr
# |
Parameters to be Inspected |
Compliance |
Non
Conformance |
Auditors
Comments |
|||||||||
Y |
N |
NA |
Major |
Minor |
|||||||||
1. |
Does the design of the area permit a view of all the
operations from outside? |
||||||||||||
2. |
Does the manufacturing process of DPIs carried out with grade
A by a grade B environment? |
|
|
|
|
|
|
||||||
3. |
Does the aseptic filling & sealing area, minimizing
the shedding and the accumulation of particles and microorganisms and easy to
clean? |
|
|
|
|
|
|
||||||
4. |
Does the pipes, lighting fixtures, points of ventilation
and other services designed in such a way to permit their easy cleaning and
sanitation? |
|
|
|
|
|
|
||||||
5. |
Does the company have adequate sterilizing, depyrogenating,
filling equipment? |
|
|
|
|
|
|
||||||
6. |
Does sterile area air handling unit run 24/7 except for
shut down due to routine maintenance to maintain sterile environment? |
|
|
|
|
|
|
||||||
7. |
Does DOP testing & ACH & non-viable particle
counting of LFH and HVAC system which serve the sterile operations are validated
externally? |
|
|
|
|
|
|
||||||
8. |
Does there an SOP for environmental monitoring for
the aseptic manufacturing area available? |
|
|
|
|
|
|
||||||
9. |
How does surface &
viable air sampling performed? |
|
|
|
|
|
|
||||||
10. |
At what temperature for how long are samples
incubated results are documented? |
|
|
|
|
|
|
||||||
11. |
What nutrient media is used for environmental
monitoring? |
|
|
|
|
|
|
||||||
12. |
Does there standardized and validated autoclave
loads for nutrient media used for environmental monitoring? |
|
|
|
|
|
|
||||||
13. |
Does growth promotion tests (GPT) performed on nutrient
media that is used for environmental monitoring? |
|
|
|
|
|
|
||||||
14. |
How is sterility verified for each lot of nutrient
media that is used for environmental monitoring? |
|
|
|
|
|
|
||||||
15. |
How is nutrient media
stored prior to use? |
|
|
|
|
|
|
||||||
16. |
Does there adequate gowning room available before
entering the sterile areas? |
|
|
|
|
|
|
||||||
17. |
Does SOP foe gowning and degowning & entry into
sterile area available? |
|
|
|
|
|
|
||||||
18. |
Are there gowning room exclusive of the aseptic
manufacturing area? |
|
|
|
|
|
|
||||||
19. |
Does the gowning room designed with air locks&
interlocking? |
|
|
|
|
|
|
||||||
20. |
Does there any type of
alarm to prevent opening of more than one door in a time? |
|
|
|
|
|
|
||||||
21. |
Does there a dress cabinet available for the conditioning
of the clothes for use in the aseptic manufacturing area after its
sterilization? |
|
|
|
|
|
|
||||||
22. |
Does there a validity period available for the gown
after sterilization? |
|
|
|
|
|
|
||||||
23. |
Does the uniforms used in aseptic areas, clean, in
good condition and sterilized prior to their use? |
|
|
|
|
|
|
||||||
24. |
Does there a separate
area for the washing & depyrogenation of vials? |
|
|
|
|
|
|
||||||
25. |
Does label attached to
cleaned objects showing its status? |
|
|
|
|
|
|
||||||
26. |
Does a validity period
established for cleaned objects? |
|
|
|
|
|
|
||||||
27. |
Does washing of empty
vials done at the least in a grade D area? |
|
|
|
|
|
|
||||||
28. |
Does the washing of
vials do with purified water? |
|
|
|
|
|
|
||||||
29. |
Do the compressed air
used in these washing machines adequately filtered? |
|
|
|
|
|
|
||||||
30. |
Does depyrogenation
ovens used are validated? |
|
|
|
|
|
|
||||||
31. |
Does depyrogenation
cycles validated & recorded? |
|
|
|
|
|
|
||||||
32. |
How frequently is the
sterile area cleaned/disinfect/sanitized? |
|
|
|
|
|
|
||||||
33. |
What cleaning agents
or disinfectants are used? |
|
|
|
|
|
|
||||||
34. |
Does cleaning agents or disinfectants rotated? |
|
|
|
|
|
|
||||||
35. |
Does their SOP for the
cleaning and disinfection of sterile area available? |
|
|
|
|
|
|
||||||
36. |
Does the area cleaned,
within 24 hours after ending the process activities? |
|
|
|
|
|
|
||||||
37. |
Does a validity period
established for area cleaning? |
|
|
|
|
|
|
||||||
38. |
Does their SOP of disinfection describe type, concentration
& contact time of disinfectants and record available? |
|
|
|
|
|
|
||||||
39. |
Does their SOP & record for disinfectant
preparation and sterilization available? |
|
|
|
|
|
|
||||||
40. |
Does the
location of the equipment facilitate area & equipment cleaning? |
|
|
|
|
|
|
||||||
41. |
Does the
cleaning procedure validate? |
|
|
|
|
|
|
||||||
42. |
Does there a log book for every equipment usage? |
|
|
|
|
|
|
||||||
43. |
Does their calibration records of the
equipment/instruments available? |
|
|
|
|
|
|
||||||
44. |
Does the unused equipment remove from the production
areas? |
|
|
|
|
|
|
||||||
45. |
Does the equipment in
repair identified as such? |
|
|
|
|
|
|
||||||
46. |
Do their flow charts showing the production steps
and identify critical points? |
|
|
|
|
|
|
||||||
47. |
Does entry of maximum number of personnel’s in aseptic
area established? |
|
|
|
|
|
|
||||||
48. |
Does gases used for purging
adequately filtered? |
|
|
|
|
|
|
||||||
49. |
Does clean steam used
in the sterilization cycles? |
|
|
|
|
|
|
||||||
50. |
Does validation
program for moist heat sterilization performed and recorded? |
|
|
|
|
|
|
||||||
51. |
Does
Biological & Chemical indicators used at each sterilization & recorded?
|
|
|
|
|
|
|
||||||
52. |
Does material or components transferred to
the aseptic area by air lock? |
|
|
|
|
|
|
||||||
53. |
Does media fill conducted with culture medium, in
the working conditions, at least on a semiannual frequency on a minimum of
3333 units & recorded? |
|
|
|
|
|
|
||||||
54. |
Does the causes of any
detected contamination investigated & recorded? |
|
|
|
|
|
|
||||||
55. |
Does the aseptic
filling area designated with class 100 with a background of class 1000 which
represents the sealing area? |
|
|
|
|
|
|
||||||
56. |
Does there terminal HEPA
filters available? |
|
|
|
|
|
|
||||||
57. |
What are the minimum air
changes per hour? |
|
|
|
|
|
|
||||||
58. |
Does the area capable
of complying with the maximum temperature of 22°C±2oC and Relative
humidity NMT 45%? |
|
|
|
|
|
|
||||||
59. |
Do the laminar flow
hoods provide class 100 air over the product? |
|
|
|
|
|
|
||||||
60. |
Does all the utensils
in the aseptic filling area sterilizable by hot air or steam? |
|
|
|
|
|
|
||||||
61. |
Does all the machine
parts sterilized prior to use? |
|
|
|
|
|
|
||||||
62. |
Does filled vials
inspected for particulars and container defects prior to packing? |
|
|
|
|
|
|
||||||
63. |
Does the types of
rejected vials documented? |
|
|
|
|
|
|
||||||
64. |
Does there a written
procedure for handling rejected vials? |
|
|
|
|
|
|
||||||
65. |
Does inspectors
trained & training documented & received an eye examination? |
|
|
|
|
|
|
||||||
66. |
Does the line labeled during packing indicating
status of product? |
|
|
|
|
|
|
||||||
67. |
Does QC inspectors checking and documenting the
packaging operations? |
|
|
|
|
|
|
||||||
68. |
Does the number of packed containers reconciled with
the amount of filled containers that were delivered for packaging? |
|
|
|
|
|
|
||||||
69. |
Does the
reconciliation documented? |
|
|
|
|
|
|
||||||
Chapter # 8-Manufacturing (Oral Dosage Form) |
|||||||||||||
Sr
# |
Parameters to be Inspected |
Compliance |
Non
Conformance |
Auditors
Comments |
|||||||||
Y |
N |
NA |
Major |
Minor |
|||||||||
1. |
What is the SOP to eradicate cross contamination? |
|
|
|
|
|
|
||||||
2. |
Does the temperature log sheets maintain during the manufacturing
cycle? |
|
|
|
|
|
|
||||||
3. |
What safety measures are adopted for the personnel working
in manufacturing? |
|
|
|
|
|
|
||||||
4. |
Does the IPQ equipped with calibrated hygrometers? |
|
|
|
|
|
|
||||||
5. |
Does the area cleaned and documented? |
|
|
|
|
|
|
||||||
6. |
Does humidifiers used at the time of filling? |
|
|
|
|
|
|
||||||
7. |
Does filling machine automatic, semi-automatic or manual? |
|
|
|
|
|
|
||||||
8. |
How does the polishing of filled capsules done? |
|
|
|
|
|
|
||||||
9. |
Does yield of the batch processed monitored &
recorded? |
|
|
|
|
|
|
||||||
10. |
Does the deviations from the expected yield are recorded
and investigated? |
|
|
|
|
|
|
||||||
11. |
Does the records of
use and maintenance of equipment kept? |
|
|
|
|
|
|
||||||
12. |
Does the
instruments correctly labeled indicating the validity of calibration? |
|
|
|
|
|
|
||||||
13. |
Does the equipment
not in use identified & removed from the production area? |
|
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|
|
||||||
14. |
Does all equipment
and containers cleaned after their use, is it documented? |
|
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|
||||||
15. |
Does a confirmation of one product at a time in processing
room available? |
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|
||||||
16. |
Do personnel in production carry out the verification of
the weight of the raw materials used in the manufacturing of each lot? |
|
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|
|
||||||
Chapter # 9- Warehouse |
|||||||||||||
Sr
# |
Parameters to be Inspected |
Compliance |
Non
Conformance |
Auditors Comments |
|||||||||
Y |
N |
NA |
Major |
Minor |
|||||||||
1. |
Does there physically separated storage areas for Raw
& Packaging material? |
|
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|
|
|
|
||||||
2. |
Does storage areas enclosed and locked, where required? |
|
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|
|
||||||
3. |
Does storage area available for organic solvents &
Inflammable materials? |
|
|
|
|
|
|
||||||
4. |
Does there a quarantine storage area available for raw
materials and packaging materials and finished products before release? |
|
|
|
|
|
|
||||||
5. |
Does there a segregated area for rejected materials? |
|
|
|
|
|
|
||||||
6. |
Does separated areas for toxic substances & psychotropic
agents available? |
|
|
|
|
|
|
||||||
7. |
Does the storage areas for materials of adequate size? |
|
|
|
|
|
|
||||||
8. |
Does warehouse lighting and ventilation adequate? |
|
|
|
|
|
|
||||||
9. |
Does humidity and temperature control are regulated &
monitored with calibrated hygrometers & documented? |
|
|
|
|
|
|
||||||
10. |
Does the possibility of entering insects, rodents, birds
in the building completely avoided? |
|
|
|
|
|
|
||||||
11. |
Does the warehouse adequately staffed & properly
supervised? |
|
|
|
|
|
|
||||||
12. |
Does each delivery visually checked on receipt for deterioration
& spillage? |
|
|
|
|
|
|
||||||
13. |
Does there SOPs available for handling of raw
materials, packaging materials, finished product, sampling, quarantine
release/storage? |
|
|
|
|
|
|
||||||
14. |
Does the record on incoming goods includes date of
receipt, date of releasing, expiry date, supplier name, and manufacturer name
and batch number? |
|
|
|
|
|
|
||||||
15. |
Does there similar record for outgoing goods including
delivering document number? |
|
|
|
|
|
|
||||||
16. |
Does stock record maintained so that stock
reconciliation can be made? |
|
|
|
|
|
|
||||||
17. |
Does the raw materials labeled, including the name designated
in the specs? |
|
|
|
|
|
|
||||||
18. |
Does each raw material used only after release from
QC department? |
|
|
|
|
|
|
||||||
19. |
Does there a stock rotation program?(First Expiry
First out-FEFO) or (First Approved First Out )FAFO (First Inn First Out) FIFO |
|
|
|
|
|
|
||||||
20. |
Does composite sampling is done to assure that all
containers contain the correct raw materials and are not mislabeled by the
supplier? |
|
|
|
|
|
|
||||||
21. |
Does stocks of raw materials inspected at intervals
to ensure that the containers are properly closed and labeled and are in a
good condition? |
|
|
|
|
|
|
||||||
22. |
Does stocks of raw materials sent to QC for retesting
after a definite storage period to assure the product quality? |
|
|
|
|
|
|
||||||
23. |
Does the materials stored under suitable
environmental conditions? |
|
|
|
|
|
|
||||||
24. |
Does inventory cards periodically reconciliated? |
|
|
|
|
|
|
||||||
25. |
If a discrepancy is found, is it recorded and
justified? |
|
|
|
|
|
|
||||||
26. |
Does rejected materials identified, segregated from
approved materials and stored in the restricted area? |
|
|
|
|
|
|
||||||
27. |
Does rejected materials destroyed or immediately returned
to the supplier? |
|
|
|
|
|
|
||||||
28. |
Does there any program for general housekeeping? |
|
|
|
|
|
|
l
Chapter# 10-Quality Control Department |
|||||||||||||
Sr
# |
Parameters
to be Inspected |
Compliance |
Non Conformance |
Auditor
Comments |
|||||||||
Y |
N |
NA |
Major |
Minor |
|||||||||
1. |
Does QC establish and revise control procedures and
specifications? |
|
|
|
|
|
|||||||
2. |
Does QC provide revision of the specifications to comply
with specs? |
|
|
|
|
|
|||||||
3. |
Does QC prepare detailed written instructions for carrying
out each inspections, test and analysis? |
|
|
|
|
|
|||||||
4. |
Does QC maintain retained sample for future reference? |
|
|
|
|
|
|||||||
5. |
Does QC release or reject each batch of raw material,
intermediate, bulk or finished product? |
|
|
|
|
|
|||||||
6. |
Does QC review all documentation before authorizing
release for marketing? |
|
|
|
|
|
|||||||
7. |
Does QC evaluate the stability of all finished products on
an on-going basis? |
|
|
|
|
|
|||||||
8. |
Does QC evaluate & approve standard master
formulation, product specifications and production equipment cleaning and
sanitation procedure? |
|
|
|
|
|
|
||||||
9. |
Does QC perform vendor qualification that meet the
company's established quality specifications? |
|
|
|
|
|
|
||||||
10. |
Does QC take part or assist in validation program? |
|
|
|
|
|
|
||||||
11. |
Does QC evaluate all complaints received about any
batch, to take appropriate corrective actions? |
|
|
|
|
|
|
||||||
12. |
Does QC prepare secondary reference standards & store
under proper condition? |
|
|
|
|
|
|
||||||
13. |
Does QC maintain analytical records of the tests of
all samples? |
|
|
|
|
|
|
||||||
14. |
Does QC evaluate return drug products and determine
whether such drugs could be released or reprocessed or should be destroyed? |
|
|
|
|
|
|
||||||
Participate in the self-inspection program? |
|
|
|
|
|
|
|||||||
16. |
Does QC analyst engaged in analysis have proper
education to perform tests? |
|
|
|
|
|
|
||||||
17. |
Does detailed, written job descriptions available
for all employees? |
|
|
|
|
|
|
||||||
18. |
Does the employees knowledgeable about their job
functions? |
|
|
|
|
|
|
||||||
19. |
Do personnel wear protective clothing such as face
mask, and gloves during work? |
|
|
|
|
|
|
||||||
20. |
Does QC lab designed, equipped as per approved
layout plan? |
|
|
|
|
|
|
||||||
21. |
Does the design of the QC laboratory consider the
suitability of construction materials, fume prevention and ventilation? |
|
|
|
|
|
|
||||||
22. |
Does QC laboratory physically separated from the
production department? |
|
|
|
|
|
|
||||||
23. |
Does the QC, and microbiological lab segregated from
each other? |
|
|
|
|
|
|
||||||
24. |
Does adequate air supply assured in instrumental
& microbiological lab? |
|
|
|
|
|
|
||||||
25. |
Does separate air handling units installed for microbiological
lab? |
|
|
|
|
|
|
||||||
26. |
Does QC lab maintained in a good state of repair? |
|
|
|
|
|
|
||||||
27. |
Does QC lab neat and orderly with sufficient space
for equipment and operations? |
|
|
|
|
|
|
||||||
28. |
Does there evidence of good housekeeping? |
|
|
|
|
|
|
||||||
29. |
Does there a special room for sterility testing? |
|
|
|
|
|
|
||||||
30. |
Does the environment in the microbiological room
controlled? |
|
|
|
|
|
|
||||||
31. |
Does there a separate instrument lab available? |
|
|
|
|
|
|
||||||
32. |
Does sensitive instruments lab have controlled temperature
and humidity and is there any vibration-proof bench for balances? |
|
|
||||||||||
33. |
Does inflammable materials stored in separated
enclosed cupboard? |
|
|
|
|
|
|
||||||
34. |
Does access into each room limited? |
|
|
|
|
|
|
||||||
35. |
Does all equipments available suitable to the
testing procedures? |
|
|
|
|
|
|
||||||
36. |
Does equipment/instruments serviced, calibrated
& maintained properly? |
|
|
|
|
|
|
||||||
37. |
Does there provisions for corrections when limits
are not met? |
|
|
|
|
|
|
||||||
38. |
Does there a valid calibration sticker in each
instrument? |
|
|
|
|
|
|
||||||
39. |
Does reference standards under responsibility of a
designated person? |
|
|
|
|
|
|
||||||
40. |
Does secondary working standards established by the
applications of appropriate tests? |
|
|
|
|
|
|
||||||
41. |
Does the label of the secondary reference standards
indicate the assay, date of manufacture, date of standardization, expiry
date, and storage condition? |
|
|
|
|
|
|
||||||
42. |
Does all chemical reagents recorded upon receipt or
preparations? |
|
|
|
|
|
|
||||||
43. |
Does written SOPs available for the preparation of
reagents ? |
|
|
|
|
|
|
||||||
44. |
Does reagents labeled with respect to date of
preparation, concentration, shelf-life, storage condition and signs of the QC
analyst? |
|
|
|
|
|
|
||||||
45. |
Does result, especially where calculations are
involved, checked by QC manager before
the material or product is released or rejected? |
|
|
|
|
|
|
||||||
46. |
Does accuracy and reproducibility of the test
methods established? |
|
|
|
|
|
|
||||||
47. |
Does testing procedures established for raw
material, intermediate, and finished product and packaging materials available? |
|
|
|
|
|
|
||||||
48. |
Does standard formats available to record the result
of analysis ? |
|
|
|
|
|
|
||||||
49. |
Do retained samples consist of at least the twice
the quantity necessary to perform all the required tests except those for
sterility? |
|
|
|
|
|
|
||||||
50 |
Does appropriately labeled samples collected from
each batch of raw material and finished products retained? |
|
|
|
|
|
|
||||||
51 |
Does there an approved annual validation program for
all equipment in lab? |
|
|
|
|
|
|
||||||
52 |
Does the quality control department conduct
validation of assay procedures? |
|
|
|
|
|
|
||||||
53 |
Is there provision of regular on-going program of
training for sampling ? |
|
|
|
|
|
|
||||||
54 |
Does all raw materials tested for conformity with
specifications? |
|
|
|
|
|
|
||||||
55 |
Does re-testing done on full quality parameters and
according to their established specifications before re- approving or
rejecting the material, if they have been stored beyond the assigned time
limit ? |
|
|
|
|
|
|
||||||
56 |
Does inprocess control conducted by quality control
department |
|
|
|
|
|
|
||||||
57 |
Does there an approved SOP for in-process control of
various products? |
|
|
|
|
|
|
||||||
58 |
Does the QC test the packaging materials according
to specifications? |
|
|
|
|
|
|
||||||
59 |
Does each finished batch checked for compliance with
established specifications before being released? |
|
|
|
|
|
|
||||||
60 |
Does a written program available for stability
studies? |
|
|
|
|
|
|
||||||
61 |
Does this program specify or include; sample size
and test intervals, storage conditions? |
|
|
|
|
|
|
||||||
62 |
Does stability study performed on new products, change
in formulation, processing method or source of raw materials? |
|
|
|
|
|
|
||||||
Chapter # 11-Packaging Area |
|||||||||||||
1. |
Does there adequate separation of packaging lines to
prevent any mix-up? |
|
|
|
|
|
|
||||||
2. |
Does packaging line identified with product name, pack,
and size and batch number? |
|
|
|
|
|
|
||||||
3. |
Does all rejected printed packaging materials counted and
destroyed under control of the supervisor? |
|
|
|
|
|
|
||||||
4. |
Does quantities destroyed recorded on the Batch Packaging
Record? |
|
|
|
|
|
|
||||||
5. |
Is there SOP for packaging Material and Operations? |
|
|
|
|
|
|
||||||
Chapter # 12-Weighing & Dispensing |
|||||||||||||
1. |
Does the area equipped adequately and separated from other
areas? |
|
|
|
|
|
|
||||||
2. |
Does the area have LAF unit? |
|
|
|
|
|
|
||||||
Does there a SOP for the cleaning of the dispensing area? |
|
|
|
|
|
|
|||||||
4. |
Does there a HVAC system installed in the room and the raw
materials handled with controlled temperature, humidity? |
|
|
|
|
|
|
||||||
5. |
Does weighing and dispensing area maintained in a clean
condition? |
|
|
|
|
|
|
||||||
6. |
Does sterile raw materials weighed and dispensed in the
sterile area? |
|
|
|
|
|
|
||||||
7. |
Does the area adequately staffed? |
|
|
|
|
|
|
||||||
8. |
Does the utensils used for weighing (Scoops, spatulas)
properly cleaned? |
|
|
|
|
|
|
||||||
9. |
Does there a SOP for cleaning the tools/utensils &
containers used in weighing and/or measuring? |
|
|
|
|
|
|
||||||
10. |
Does there an area for washing the tools/utensils &
containers used in weighing and/or measuring? |
|
|
|
|
|
|
||||||
11. |
Does these tools/utensils & containers kept clean and
labeled in a safe place? |
|
|
|
|
|
|
||||||
12. |
Does weighing balances used for weighing calibrated
regularly & recorded? |
|
|
|
|
|
|
||||||
13. |
Does the containers of the raw materials cleaned before
being opened? |
|
|
|
|
|
|
||||||
14. |
After weighing, does these containers well sealed? |
|
|
|
|
|
|
||||||
15. |
Does raw materials or components for each batch properly
identified and segregated after weighing? |
|
|
|
|
|
|
||||||
16. |
Does there a description of the documentation system?
(Responsibility for preparation, revision, distribution, storage of master
documents, SOP)? |
|
|
|
|
|
|
||||||
17. |
Does the document periodically reviewed, updated or
amended and formally authorized? |
|
|
|
|
|
|
||||||
18. |
How does document controlled? |
|
|
|
|
|
|
||||||
19. |
Does there a system for preventing the use of a superseded
document? |
|
|
|
|
|
|
||||||
20. |
Does documentation readily available to all concerned? |
|
|
|
|
|
|
||||||
21. |
Does the document and record of a batch as well as
reference sample of finished product and starting material retained for a
specified period? |
|
|
|
|
|
|
||||||
22. |
Does there document production/process specification, raw
material specification, packaging component specification, standard process
instructions including packaging, batch record, analytical methods, QA release
procedure? |
|
|
|
|
|
|
||||||
23. |
Does the following documents available? equipment specifications, QC SOPs, training SOPs and
record, deviation record, calibration record and QC Forms, validation
documents, reconciliation of batches of RM and major packing components QA
SOPs QA Forms Master document list site master file master validation plan
qualification record? |
|
|
|
|
|
|
||||||
24. |
How long document retained after release of the batch? |
|
|
|
|
|
|