GMP - Records for APIs

Lesson Code: BGI-1101. This e-Lesson is aimed at personnel who require an overview of records in API manufacturing, why these records are essential, how and where they are used, the type of information they typically contain, and the rules for how they should be completed.

  • Category: API Manufacturing GMP - Intermediate



  • Define 'record' as it relates to API manufacturing
  • Explain why records are necessary in API manufacturing
  • List examples of the types of records used in API manufacturing
  • Explain why traceability is essential in API 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 maintenance and cleaning records