AUDITING IN CAPSULE PRODUCTION DEPARTMENT PHARMACEUTICAL QUALITY ASSURANCE

AUDITING IN CAPSULE PRODUCTION DEPARTMENT PHARMACEUTICAL QUALITY ASSURANCE DEPARTMENT OF PHARMACEUTICAL SCIENCES & TECHNOLOGY BIRLA INSTITUTE OF TECHNOLOGY, MESRA

LEARNING OUTCOME • After watching this Video lecture we are going to LEARN: • How to perform an audit of a capsule production department. • What are the pre approval inspections. • How to control the raw materials and the laboratory equipment for capsule testing.

CLASSIFICATION

CLASSIFICATION • Auditing of capsule production department can be classified into two different parts: Product development reports & Pre approval inspection.

PRODUCT DEVELOPMENT REPORTS

PRODUCT DEVELOPMENT REPORTS • It should satisfy the need of company where investigator should review the product development reports which will in turn reduce the time to inspect the process. It contains following parts: a. b. c. d. e. f. Drug substance characterization. Manufacturing procedure. In process testing. Finished product testing. Dissolution profile. Stability.

PRE APPROVAL INSPECTION

PRE APPROVAL INSPECTION • Here the data and specification for the validation protocol may be developed by the following approval application. • The following areas must be covered during the pre approval inspection: a. b. c. d. e. f. g. Master formula. History section. Development data. Inspection of facility. Raw material. Laboratory. Equipment.

• Now, please take a pause for 2 minutes to recapitulate the topics we have discussed, and try to answer the following questions: • How is pre approval inspection different from product development report?

CONTINUED… a. Master formula: This document must include full scale commercial process including finish process and product. The auditor should compare the process file in application to the process used to manufacture the batch. b. History section: It is used to identify the batches used for. c. Development data: During the development phase theoretical process parameter must be identified and established. d. Inspection of facility: It is important to physically inspect the facility to assure that the production of hard and soft gelatin capsules are suitable for proposed manufacturing batches. e. Raw materials: Inventory records are good the good source of the identification of batches used for production development. f. Laboratory: Evaluate new laboratory procedures and methods, laboratory equipment, method validation data to determine the overall quality of laboratory operation and the ability to comply with GMP regulation. g. Equipment: At the time of pre-approval it is expected that the equipment is in place and properly qualified.

Conclusion

CONCLUSION • Thus auditing is very important in capsule production department because we get to know about the manufacturing procedure of the capsule, the inprocess testing, the dissolution profile and the stability of the capsule through which we can assure the quality of the product.

Prepared by: Ms. Nilanjana Ghosh Mr. Fahaduddin Dr. Kishanta K. Pradhan Dr. Manik Ghosh PHARMACEUTICAL QUALITY ASSURANCE DEPARTMENT OF PHARMACEUTICAL SCIENCES & TECHNOLOGY BIRLA INSTITUTE OF TECHNOLOGY, MESRA