Medical and pharmaceutical
ISO 15378:2017
Primary packaging materials for medicinal products
ISO 15378 sets out requirements for a quality management system for organisations that make primary packaging materials for medicinal products: the containers, closures, films and other components that come into direct contact with a medicine.
It builds good manufacturing practice (GMP) requirements for these materials onto the requirements of ISO 9001:2015.
Who it suits
Manufacturers of glass and plastic containers, closures and stoppers, blister films and foils, tubes, pouches, and components of devices that deliver a dose, where these are in direct contact with the medicine. Pharmaceutical companies may ask their packaging suppliers for ISO 15378 as evidence of a GMP-based quality management system.
What certification involves
ISAO, or a certification body accredited for ISO 15378, audits the system in two stages: first the scope, the documentation and readiness; then, on site, how GMP is applied in practice, for example hygiene and contamination control, validation of processes and equipment, change control, batch records, traceability, and the handling of complaints and deviations. The certificate states the packaging materials, processes and sites covered. Certification does not replace the audits and qualification that pharmaceutical customers carry out on their suppliers, or regulatory inspection. Certificates are normally valid for three years, with surveillance audits at least once a year and a recertification audit before expiry. ISAO carries out this certification itself, and also accredits certification bodies to do it. Every certificate ISAO issues, and every certificate issued under ISAO accreditation, is recorded on the public register.
Key themes
- Good manufacturing practice applied to packaging materials, alongside ISO 9001 quality management
- Risk management for product quality and patient safety
- Control of the production environment, hygiene and contamination
- Validation of processes and equipment
- Change control, batch documentation and traceability
- Handling of complaints, deviations, and returned or rejected materials
- Control of suppliers and outsourced processes
Edition
- Current edition
- ISO 15378:2017
ISO 15378:2017, the fourth edition, was published in September 2017 and replaced ISO 15378:2015. It is based on ISO 9001:2015, not on the 2026 edition of ISO 9001. ISO confirmed it at its most recent periodic review. An amendment published in February 2024 asks the organisation to consider whether climate change matters to it when it reviews its context, and adds a note that interested parties may have expectations about climate change. ISO 15378:2017 is the current edition.
Check a certificate for ISO 15378:2017
- Enter the certificate number or verification code at Verify a certificate, or scan the QR code on the certificate. The record shows the certificate's status today, for example valid, suspended, withdrawn or expired.
- Compare the organisation name, scope and sites on the record with the copy you were given. Check the packaging materials, processes and sites named in the scope.
- Check who issued the certificate, as named on the record. Where a certification body accredited by ISAO issued it, the record shows the status of that accreditation and its accreditation number, and says so if the accreditation did not cover ISO 15378:2017 when the certificate was issued.
- If the certificate is not on the register, ISAO cannot confirm it: it may have been issued under another accreditation, or a detail may be wrong. Ask the issuing body, and report a concern if something does not look right.
Related standards
This is ISAO’s own summary, not the text of the standard. Copies of ISO 15378:2017 can be bought from ISO or from national standards bodies.