ISO 15378 for medical devices

ISO 15378 is aimed at manufacturers of primary packaging materials for medicinal products — everything that is in direct contact with the drug: syringe barrels, ampoules, vials, stoppers, blister and pouch films. It combines the requirements of ISO 9001 with the principles of good manufacturing practice (GMP): hygiene and contamination control, validation, change and deviation management, and traceability down to the batch.

For medical technology the standard matters where drug and device meet: prefilled syringes, pens and autoinjectors, combination products within the meaning of Article 117 of the MDR, and suppliers producing for both pharma and medtech. Anyone supplying primary packaging will almost always be asked about ISO 15378 by pharmaceutical customers; an ISO 13485 certificate alone does not cover the GMP requirements.

The standard must be distinguished from ISO 11607, which governs packaging for terminally sterilised medical devices and for which there is no company certificate of its own. And a certificate says nothing about the suitability of a specific packaging material for a specific drug — that remains a matter for the pharmaceutical manufacturer's stability and compatibility studies.