Beruflich Dokumente
Kultur Dokumente
Sr # (Contents) Page #
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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)
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:
2.4 Are the doors, windows, walls, ceiling and floor such that no
holes or cracks evident (other than those intended by design)?
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)
3.3 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?
3.6 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
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6.0 VENDOR QUALIFICATION
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?
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
9.3 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?
10.2 If answer yes to the above did you have any drug recall in the past
2 year? (Please also mention the name of products)
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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?
12.3 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?
13.10 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
14.1.6.2 Does the facility have approved written procedures for checking
and calibration of each piece of measurement equipment?
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14.1.7 MATERIAL/COMPONENT
14.2.2 If answer yes to the above what are the controls to log any
irregularities?
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?
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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?
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14.3.2
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14.3.2
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14.3.2
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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
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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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14.3.3
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14.3.40 At what temperature and for how long are WFI samples
incubated?
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?
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14.4 DEPACK / PREPARATION COMPONENT 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?
14.4.8 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?
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14.5 STERILIZER / OVEN LOADING ROOM
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)
Are sterile area air handling unit run 24/7 except for shut down
due to routine maintenance to maintain sterile environment?
14.8.
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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?
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14.9. How is viable air sampling performed?
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How is surface sampling performed?
14.9.
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14.9.
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14.9.
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14.9.1 At what temperature for how long are environmental monitoring
0 samples incubated?
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?
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How is nutrient media stored prior to use?
14.9.1
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14.9.1
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14.10 ASCEPTIC BATCHING AREA
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?
14.10.9 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?
14.11.6 Are the walls, floors and ceilings non-porous and sanitizable ?
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?
14.11.20 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?
14.12.5 Are sanitizing agents prepared with WFI and filter sterilized prior
to use?
14.12.7 Is sanitization agent allowed to dry and then rinsed off with WFI?
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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?
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14.15 PACKAGING
14.15.1 Is the packaging line equipped with capping equipment?
14.15.1 Upon completion of packaging, are the labels, inserts and cartons
0 reconciled?
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?
14.16.6 What are the controls for the temperature logging of the dryers?
14.16.9 Are the granules checked by QC for releasing the batch for
compression?
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?
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14.16.1 Are there temperature log sheets maintain during the
5 manufacturing cycle?
14.16.2 Are the deviations from the expected yield are recorded and
4 investigated?
14.16.2
5
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PACKAGING
14.16.2
6 What is the glass type of the bottles used?
14.17.6
14.17.7
14.17.8
14.17.9
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14.17.1
0
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15.0 REPROCESSING
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?
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17.0 WAREHOUSING / DISTRIBUTION
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?
17.9 Are there no expired raw materials in the raw material store(s)?
17.11 After release by quality control, are raw materials and packaging
materials released on a FIFO (first in first out) basis?
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18.0 ENVIRONMENT, HEALTH & SAFETY
18.1 Does the company monitor and maintain incident / accident data
etc to create awareness and develop improvement plans?
18.3 Does the company have fire fighting facility having fire hydrants,
sprinkler system & trained people to handle the emergency?
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