QA021: SOP FOR INCIDENT REPROTING
OBJECTIVE: To describe the procedure for identifying, documenting, investigating, and reporting any incident or deviation that may impact product quality, Good Manufacturing Practices (GMP) compliance, safety, or regulatory requirements within the pharmaceutical manufacturing facility. SCOPE: Applicable to all departments of the manufacturing site such as Production, Quality Assurance (QA), Quality Control (QC), Engineering, Microbiology, Warehouse, […]