: Documentation of Corrective and Preventive Actions taken after identifying a non-conformity.
In the pharmaceutical industry, documentation is often described by the adage, "If it isn't documented, it didn't happen." Quality Assurance (QA) documents are the essential records that ensure every drug is safe, effective, and manufactured according to stringent regulatory standards like Good Manufacturing Practices (GMP) . These documents create a "quality ecosystem" that provides traceability, audit readiness, and process consistency throughout a drug's lifecycle. The Hierarchy of QA Documentation list of qa documents in pharmaceutical industry
Summaries of inspections conducted on suppliers, contract laboratories, or third-party logistics providers. : Documentation of Corrective and Preventive Actions taken
A copy of the MPCR executed for a specific batch, serving as a legal record of the materials used, weights, signatures, timestamps, and process parameters during manufacturing. The Hierarchy of QA Documentation Summaries of inspections
Comprehensive List of QA Documents in the Pharmaceutical Industry
Provide a for a Batch Production Record (BPR) audit.
1. Core Quality Management System (QMS) Manuals and Policies