GMP – Records in Finished Dose Manufacturing
Lesson Code: PGI-1101. This e-Lesson is aimed at personnel who work in the pharmaceutical and biopharmaceutical industries and maintain records for finished dose manufacturing in accordance with GMP Regulations.
- Category: Pharmaceutical GMP - Intermediate
Description
After completing this e-Lesson you will be able to:
- Explain why records are essential in finished dose manufacturing
- List examples of the types of records used in finished dose manufacturing
- Explain why traceability is essential in finished dose manufacturing
- Define 'record' as it relates to finished dose manufacturing
- Give examples of general rules for completing records
- List the information typically contained in production, materials, laboratory, and distribution records
- List the information typically contained in equipment use, maintenance, and cleaning/sterilization records
