ISO 15378 is the international quality management standard specifically designed for manufacturers of primary packaging materials for the pharmaceutical industry. It is a sector-specific version of ISO 9001 (Quality Management) combined with the principles of Good Manufacturing Practice (GMP).
Detailed records for every step of the manufacturing process. iso 15378 key pointspdf free
ISO 15378 combines ISO 9001 quality management with Good Manufacturing Practice (GMP) for primary pharmaceutical packaging, focusing on contamination control, risk management, and traceability. Free resources often include summaries and checklists from consulting firms, though the full standard requires purchase. For an overview of key points regarding primary packaging standards for medicinal products, see CertBetter . ISO 15378 is the international quality management standard
Technical proof that processes (like sterilization) consistently produce the intended results. ISO 15378 combines ISO 9001 quality management with
ISO 15378:2017 integrates ISO 9001 quality management principles with specific Good Manufacturing Practices (GMP) for primary packaging materials of medicinal products. Key requirements include risk management, traceability, controlled environments, and validated processes to ensure safety and compliance. Read a detailed guide at CertBetter .
Helps manufacturers meet international regulations, including those from the U.S. FDA and European directives. Why Manufacturers Need It