Training new and old employees on cGMP guidelines is an essential require-ment of the pharmaceutical industry in order to maintain and produce quality pharmaceutical products on a continuous basis, and to assure patients that the products used meet safety, efficacy, and potency requirements.
Following is the generic audit checklist of which the personnel working in the pharmaceutical industry must be aware:
2. General
Check the following:
1. Workers coming into direct contact with the product who have been medically examined and cleared are allowed in the area.
2. Workers in the area are wearing clean uniforms and caps.
3. All areas are cleaned per respective SOPs.
4. No eating, smoking, or unhygienic practices are allowed in the manufacturing area.
5. Facility is neat and clean, and lockers provided in the facility are clean. SOP of cleaning is followed.
6. All manufacturing operations are carried out in separate areas intended for such purposes.
SOP No. Val. 500.20 Effective date: mm/dd/yyyy
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142 Validation Standard Operating Procedures 500.20
7. All apparatus and equipment to be used in the operation have been cleaned per their respective SOPs.
8. The contents of all vessels and containers used in manufacturing and storage between manufacturing stages are identified by clearly legible labels having all the required information.
9. All machines and equipment bear legible clearance labels having all the required information.
10. All respective SOPs are followed.
11. Insecticutors on every entrance are available as appropriate.
12. Under-construction or maintenance areas should be well segre-gated from the manufacturing area.
13. All the specific areas have required temperature, relative humidity (Rh), and air pressures.
14. Clogs are in use instead of street shoes.
15. Gauges and measuring equipment have valid calibration tags.
3. Stores and Weighing Area
1. Weighing and measuring equipment are of appropriate accuracy and are calibrated.
2. All incoming supplies of raw material and packaging commodities are stored per SOP.
3. Stores’ receiving labels are fixed on all containers and sample labels are affixed as appropriate.
4. Release labels are fixed on approved items and rejected labels on rejected items.
5. All rejected items are kept segregated from other materials.
6. Cleaning in the area is done according to schedule and is effective.
7. Workers coming into direct contact with product are wearing clean masks.
8. Curtains of the weighing booth are drawn during dispensing to avoid cross-contamination.
9. Dispensed materials are kept in locked, clean cages with proper labels.
10. Log books of the weighing area and calibration records of weighing balances are updated.
11. Raw material card entries are on time, complete, and correct.
SOP No. Val. 500.20 Effective date: mm/dd/yyyy
Approved by:
500.20 Validation Standard Operating Procedures 143
12. Temperature and Rh are within requirements and limits, and the records are maintained.
13. Storage of raw materials, packaging materials, bulk products and finished product is appropriate.
4. Packaging Section
1. All packed units after completion of batch are kept in finished goods area in stores.
2. All coded and uncoded labels and boxes are kept in cages with identification labels.
3. Workers coming into direct contact with products are wearing masks.
4. Operators wear disposable gloves while handling the product.
5. There is proper physical separation or segregation between the lines.
6. Temperature and humidity records of the dry and soft packaging area are updated and maintained.
5. Soft and Dry Production
1. All employees are attired appropriately according to the specific garmenting SOP for soft and dry production.
2. Operators are wearing masks and gloves and using beard covers (head cover for covering beard) when necessary.
3. Relevant cleaning procedures for area and equipment should be followed.
4. Cleaning schedules should be followed.
5. Work areas are clearly labeled.
6. All vessels and utensils are labeled as to their cleanliness status.
7. Manufacturing instructions are at hand during processes and are approved and accurately followed.
8. Valid calibration labels are on all equipment.
9. Vessels should be labeled with product lot number and stage of processing.
10. Sampling tools are dedicated for each building and should be used accordingly.
11. Maintenance tools should also be dedicated for each building.
SOP No. Val. 500.20 Effective date: mm/dd/yyyy
Approved by:
144 Validation Standard Operating Procedures 500.20
12. Air inlets and outlets are functional.
13. Materials holding containers are intact and can be closed completely.
14. Materials and personnel flow are dedicated and being followed.
15. Temperature and humidity are under the limits.
16. Dispensing and all processing are carried out in the prescribed and dedicated areas.
17. Line clearance procedure should be strictly followed and counter-checked to avoid mix-ups.
18. Devices for the presence of labels and overprinting are challenged prior to initiation of work.
19. Effective segregation of printed materials from not printed and rejected materials is in place.
20. Utilities lines are clearly marked and labeled.
21. Storage of product (bulk and finished) is under their labeled or prescribed storage condition.
22. All records must be completed at the time of action.
23. Employees have undergone training in GMPs, SOPs, and sterile area techniques and respective SOPs are followed
24. Employees have full knowledge about their job functions.
25. The department is well maintained for cleanliness and spacious enough for equipment and operations.
26. Area and equipment are clean at the end of the day’s work.
27. Specific procedure for the cleaning of major equipment is followed.
28. Daily calibration records of balances are complete.
29. Correction to writing errors are made by crossing out, initialing, dating, and writing the reason (if necessary).
30. All the products have status labels.
31. All the log books (equipment and area usage records) are updated.
6. Good Documentation Skill
1. The correct ink color and type of proper writing instrument are used (pencils should not be used).
2. Additional documents (e.g., charts, printout) are properly included.
3. Printing and writing can be easily read.
4. Errors are properly corrected with one line through the original entry, initialed, dated, and explained (if necessary).
5. Calculations are reviewed and verified.
SOP No. Val. 500.20 Effective date: mm/dd/yyyy
Approved by:
500.20 Validation Standard Operating Procedures 145
6. Numbers are properly rounded off; the correct significant figures are used.
7. Spelling of the product names and other words is correct.
8. Lot numbers and product ID codes are doublechecked and are correct.
9. Information is recorded as it is obtained.
10. Proper formats for date and time are used.
11. All abbreviations are approved and standardized.
12. Blank spaces are properly handled.
13. The original entry is made into the official record.
In short, good documentation skill should produce proper records with the following characteristics:
Permanent
Accurate
Prompt
Clear
Consistent
Complete
Direct
Truthful
7. Parenteral Facility
1. In clean room operations, employees should be correctly attired according to relevant SOP.
2. A fresh set of garments should be used on each entry into the clean room.
3. Sets of garments ready for use should be sealed and labeled.
4. Sterile production area should be in a good state of repair and neat.
5. Relevant cleaning procedures for area and equipment should be followed.
6. Cleaning schedules should be followed.
7. Cleaning and sanitization agents per the SOP should be labeled with the expiration date.
8. Records should be maintained for the preparation of cleaning and sanitization agents.
SOP No. Val. 500.20 Effective date: mm/dd/yyyy
Approved by:
146 Validation Standard Operating Procedures 500.20
9. No simultaneous opening of doors on the clean and lesser clean class.
10. All alarm systems are functional.
11. Work areas are clearly labeled.
12. Product and product components are exposed only where pro-tected by LAF stream providing an air quality of 100 or better.
13. Handling and all working practices should be such to avoid con-tamination and generation of particles.
14. All vessels and utensils are labeled as to their cleanliness status.
15. Manufacturing instructions are at hand during processes and are approved and accurately followed.
16. Vessels should be labeled with the product lot number and stage of processing.
17. Relevant sterilization and other charts and printouts ar e fully labeled, verified, and approved.
18. Valid calibration labels are on all equipment.
19. Air inlets and outlets are functional.
20. Material-holding containers are intact and can be closed completely.
21. Materials and personnel flow is dedicated and being followed.
22. Air differentials are maintained between the different areas of processing per their levels of cleanliness.
23. Temperature and humidity are under the limits.
24. Dispensing and all processing are carried out in the prescribed and dedicated areas.
25. Line clearance procedures should be strictly followed and counter-checked to avoid mix-ups.
26. Devices for the presence of labels and overprinting should be challenged prior to initiation of work.
27. Effective segregation of printed materials from not printed and rejected.
28. Utilities lines are clearly marked and labeled.
29. Storage of product (bulk and finished) is under its labeled or prescribed storage condition.
30. All records must be completed at the time of action.
31. Watches, bracelets, jewelry, or rings should not be worn during work.
32. Persons ill or having opened or bandaged wounds should inform the supervisor and should not be allowed in the clean room areas.
33. Monitor that no adhesive tapes are used in the sterile area in future.
SOP No. Val. 500.20 Effective date: mm/dd/yyyy
Approved by:
500.20 Validation Standard Operating Procedures 147
8. Dos and Don’ts to Be Followed
Do wear identification card all the time at work.
Do follow clothing instructions before entering the plant.
Do wash hands before entering and leaving the personal facility.
Do read, understand, and follow standard operating procedures related to work.
Do follow good manufacturing practices at work.
Do observe personal hygiene at work.
Do keep nails clean, and cut them every week.
Do get a haircut every month.
Do trim beard every day before coming to work.
Do not take food and drinks inside the plant, and especially do not chew gum.
Do not enter the plant in personal clothing, street shoes, or with unwashed hands.
Do not go to the bathroom or outside the plant in working uniform, head cover, and clogs.
Do not enter the plant if suffering with some contagious disease or a skin lesion.
Do not carry anti-dust face mask, disposable hand gloves, or other working tools to lockers.
Do not keep medicines inside the locker, except as prescribed for personal use by a doctor.
Do not carry batch record and support documents in pockets or to the lockers.
Do not remove medicines from the line for personal use.
Do not taste and touch raw materials for personal experience during dispensing and processing.
Do not change labels from the container, unless authorized.
Do not remove items from the pallets, unless authorized.
Do not cough inside the plant without a handkerchief.
Do not use cosmetics and jewelry at work.
Do not keep used sanitary towels inside the lockers.
Do not sign batch records unless authorized.
Do not use sampling and other tools dedicated for building A in building B, or vice versa.
SOP No. Val. 500.20 Effective date: mm/dd/yyyy
Approved by:
REASONS FOR REVISION
Effective date: mm/dd/yyyy
First time issued for your company, affiliates, and contract manu-facturers
SOP No. Val. 500.20 Effective date: mm/dd/yyyy
Approved by: