Preventing materials from one product from contaminating another. 3. Traceability and Documentation
Traceability is crucial in the pharmaceutical supply chain. The standard requires comprehensive documentation of every stage of production, allowing for the tracking of raw materials and finished products. 4. Process Control and Validation iso 15378 key pointspdf free
Operational planning, customer communication, design/development, control of externally provided processes, production provision, and release of products. control of externally provided processes
Unlike ISO 9001, ISO 15378 explicitly requires compliance with GMP principles (based on ICH Q7). This means you must control cross-contamination, prevent mix-ups, and maintain strict hygiene—just like a drug manufacturer. iso 15378 key pointspdf free