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 0.2ยต 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?

 

 

 

 

 

 

14.   

 Does all equipment and containers cleaned after their use, is it documented?

 

 

 

 

 

 

15.   

Does a confirmation of one product at a time in processing room available?

 

 

 

 

 

 

16.   

Do personnel in production carry out the verification of the weight of the raw materials used in the manufacturing of each lot?

 

 

 

 

 

 

Chapter # 9- Warehouse

Sr #

Parameters to be Inspected

Compliance

Non Conformance

Auditors Comments

Y

N

NA

Major