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