Checklist for Audit in Ointment Manufacturing : Pharmaceutical Guidelines

Checklist for Audit in Ointment Manufacturing


Checklist for the inspection of the ointment manufacturing facility. Audit your ointment manufacturing facility with this checklist to find the problems that can compromise the product quality.
Contents:
A. Premises, Facility and Personnel Hygiene
B. Dispensing of Raw Materials
C. Manufacturing
D. Equipment
E. Packing

A. Premises, Facility and Personnel Hygiene

1. Is the Site suitable for manufacturing types of dosage forms (Ointment) specified in the Site approval form?
2. Is the plant layout conducive for unidirectional flow of man and materials?
3. Are operations performed within separate or defined areas of adequate size as per the Flow of Process?
4. Is there any anti-cancerous, Betalactum or, Steroid dosages manufactured? If Yes, What are the precautions taken for Disposal?
5. Is there Effluent Treatment Plant (ETP) in the Distance of more than 30 meters from the mfg. sites and Proper treatment of Effluents done in ETP?
6. Is there any proper Gowning procedure followed during entry, Exit and Operation of Critical Processes (Dispensing, Preparation of Aqueous or, Wax and Oil Phase and Filling)
7. Do the change rooms have: (Is there is a provision for)
  • Running water? 
  • Soap or detergent or Disinfectant? 
  • Hand dryers? 
  • ‘Wash hands’ sign? 
  • Appear clean and sanitary? 
8. Are there any SOP’s in vernacular language?
9. Whether the label of fire extinguisher, written procedure and its expiry date and location are proper?
10. Is there a written sanitation programme (SOP) containing assignments of responsibility, schedules, methods, equipment and materials to be used to properly clean the building and facilities?
11. Are records available for Daily and Weekly sanitation and housekeeping?
12. Are waste bins with lids along with transparent polybags located in appropriate areas and interval of changing to be mentioned in the SOP?
13. Is there an adequate collection or, Scrapyard for Disposal of the waste system?
14. Are drains designed with an air or mechanical brake to prevent back siphonage and Drains should be vertically in-warded?
15. Does the layout and organization of the facility prevent contamination (Mix-ups and Contamination)?
16. Is adequate lighting & ventilation provided to all areas of the department?
17. Is control of air pressure, dust and temperature adequate for the manufacturing, processing, storage or testing of the products and properly documented?
18. Is there any written procedure for air filters specifying the frequency of inspection and replacement and also cleaning?
19. Does the facility have written procedures for the safe and correct use of cleaning and sanitizing agents?
20. Whether the interior surfaces of the premises are smooth and free of cracks and open joints, covings of epoxy coated, does not shed particulate matter and permit easy and effective cleaning?
21. Whether the pipework, light fittings, ventilation points and other services are designed to avoid accumulation of dust and should not be difficult to clean? And for maintenance purpose, these are accessible from outside the mfg. areas?
22. Whether production areas are effectively ventilated with required temperature, pressure and air filtration and are monitored regularly during working and non-working periods?

B. Dispensing of Raw Materials

23. Is the Dispensing of raw materials carried out under Reverse Laminar Air Flow (RLAF) Unit?
24. Are the materials properly checked with BOM respect to Quantity, Item code and suppliers’ name by Store & production officers and cross-checked by QA before and after dispensing?
25. Is the Utensils and equipment used for Dispensing of raw materials cleaned from all types of extraneous matters?
26. Are the dispensed materials with proper status labeled?
27. Is there any disposal operation after the spillage of any materials (Liquid or, solid materials) in the floor?
28. Is there provision for dispensing of raw materials as per FIFO or, FEFO basis?
29. Is there provision for dispensing of raw materials as per sequence and color & actives dispensed at the last stage of Dispensing?

C. Manufacturing

30. Whether following responsibilities are ensured by production dept.?
  • Products are produced and stored appropriately with proper status labeling. 
  • Approve the instructions of production and to control on action to be taken against in-process findings. 
  • Is there any provision for giving Line clearance for critical process and equipment by production officer and cross-checked by QA? 
  • Are there any written procedures and Instructions followed during Manufacturing and In process checks? 
  • Is there proper Evaluation, review and signature on manufacturing records? 
  • Is all in process parameters are recorded and any minor or, major observations, deviation or, change control filled for permanent change during the manufacturing process? 
  • Are appropriate process and cleaning validations and calibrations are done for the new product, Equipment or, any modification in a process, facility and critical parameters? 
  • Is there provision for cleaning of processing areas after completion of Batches of same or, Different products? 
  • Are the Operators trained to operate the Equipment and their training records are updated? 
  • Is there proper traceability and documented evidence for each and every stages of the process? 
31. Whether the high level of sanitation and hygiene are practiced? If applicable the method or, the procedure should be validated?
32. Whether the scope of sanitization and hygiene SOP covers all i.e. personnel, premises, equipment and apparatus, production materials and containers, materials for cleaning and disinfection and anything that can cause the source of contamination?
33. Whether all the manufacturing process is clearly defined, systematically reviewed and are validated to confirm their capability to manufacture the products consistently?
34. Whether SOP’s are available for each instrument and equipment and are placed in a close proximity to equipment?
35. Is there an SOP for a batch numbering system and Batch Logging system to ensure each of the finished products is identified with a batch no.?
36. Is there an SOP for batch & lot numbering that is applied to the processing stage and to the respective packaging stage are related to each other?
37. Is there an SOP for batch numbering and which assure that the same batch numbers are not repeated? (Even for reprocessed batches)?
38. Is there an SOP and system for batch no. allocation, which is recorded immediately in a logbook? (Date of allocation, product identity, batch size)
39. Are there written procedures for testing of materials and products at different stages of manufacture, describing the methods and equipment to be used?
40. Is there any SOP for cancellation of the Batch Numbering System and same Batch No. is not repeated to any of the next batches going to manufacture?
41. Is there an SOP for sampling room cleaning?
42. Whether intermediate and bulk products are stored under appropriate conditions?
43. Whether finished products are held in quarantine before final release?

D. Equipment

44. Are all equipments used to manufacture, process or hold a product are of appropriate design and size for its intended use?
45. Are all the equipments used are suitable for their purpose with required size and capacity?
46. Are the Qualifications, SOP for Operation, Cleaning and maintenance of all equipment are available?
47. Are all the equipments are designed to qualify GMP requirements and are easy to clean effectively?
48. Noise Produced by equipment should not be more than 80 dB at the distance of 10 meters.
49. Is line clearance given to all equipment prior to use as per Line Clearance SOP?
50. Are designs and operating precautions taken to ensure that lubricants or coolants or other operating substances do not come in contact with the product?
51. Whether every equipment has a status label about cleaning, operation, maintenance and breakdown?
52. Does the cleaning procedure or start-up procedure ensure that the equipment is systematically and thoroughly cleaned?
53. Whether equipments are cleaned promptly after use?
54. Does the cleaning procedure or start-up procedure ensure that the equipment is systematically and thoroughly cleaned?
55. Are all equipments identified clearly with easily visible markings and also with a code no.?
56. Whether the Equipment Usage and maintenance logbook of every equipment is kept nearby?
57. Are there any protective devices or, safety precautions written at the site?
58. Are written procedures established for the cleaning of all the equipments and are followed?
59. Has the cleaning procedure been properly validated?
60. Is clean equipment adequately protected against contamination prior to use? Whether hold period is established?
61. Are there logbooks for major and critical equipment and which details about validations, calibrations, maintenance, cleaning, repair operations, including dates and the operations carried out by?
62. Is there a record available for maintenance of punches like, the frequency for punch inspection & polishing record and punch destruction?
63. Are there any branded lubricants used for lubrication and storage of spare parts of equipment and their proper certification available?

E. Packing

64. Are the bulk materials which properly labeled received by packing officer with an exact quantity of the received sign?
65. Are the change parts for all Ointment products available at the site?
66. Is the Rubber Stereos ordered by packing officer prior to packing?
67. Is the First and last proves of Ointment tubes/ Lamitubes, Leaflets, Inner/Cartons, Containers and Shippers by two production officers and QA officer?
68. Are there the records for Stereos ordered, Impression, Storage and destruction in the department?
69. Are the packing operation and its yield reconciliation done as per SOP?
70. Is there a procedure for in-process checks by production and QA Personnel?
71. Is there the procedure for sampling by QC during the packing operation?
72. Is there a separate partition between pack lines where two or, more products running at a time?
73. Is there a procedure to send the Products to Bonded Store Room (BSR) after completion of packing?
74. Is there a procedure for giving approval for Dispatch after passing all the tests?

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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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