Implementation of systems to track every material and production step from raw material to delivery.
The standard is a globally recognized framework that integrates ISO 9001 quality management principles with the stringent requirements of Good Manufacturing Practices (GMP) specifically for primary packaging materials for medicinal products. This standard is vital because packaging like glass vials, rubber stoppers, and plastic containers comes into direct contact with medicines, directly impacting patient safety and product efficacy. Key Components of ISO 15378 iso 15378 key pointspdf free
| Clause | Must-Have Document or Evidence | | :--- | :--- | | | External GMP issues (legal register for pharma packaging) | | 5.1 | Management commitment to GMP (visible quality policy signed by top mgmt) | | 6.1 | Risk assessment for contamination & mix-ups | | 7.1 | Calibration records for instruments (particle counters, micrometers) | | 7.5 | Validated sanitation & pest control logs | | 8.1 | Change control procedure (customer, supplier, internal changes) | | 8.5.1 | Process validation protocol & report | | 8.5.2 | Traceability from raw material batch to finished pack | | 10.2 | CAPA (Corrective and Preventive Action) system for GMP deviations | Implementation of systems to track every material and