Proof of compliance with Good Manufacturing Practices (GMP) regulations requires an array of documents and records. This documentation set includes development reports, batch master records, technology flowcharts, drafts of standard operating procedures (SOPs), process validation plans, cleaning protocols, and risk assessments. These records ensure process traceability, guide manufacturing operations, document technical details, aid in quality control, and fulfil regulatory mandates. Such documentation is essential for upholding operational consistency, ensuring product integrity, and meeting regulatory standards.
GMP Documentation
