You must maintain full traceability. Key requirements include:
It combines standard quality management (ISO 9001) with specialized pharmaceutical GMP requirements. iso 15378 key pointspdf free
The standard ensures that packaging—such as glass, plastic, rubber, or aluminum—meets the safety and quality requirements of the pharmaceutical and medical device industries. 🛡️ Key Points & Requirements You must maintain full traceability
If you supply (blisters, vials, pre-filled syringes, or IV bags) to the pharmaceutical industry, ISO 9001 alone is no longer enough. iso 15378 key pointspdf free
Requires rigorous tracking of raw materials and final products throughout the production process. Environmental Control: