ISO 15378 is the international standard for the quality management system of a company that designs, makes or supplies primary packaging materials for medicinal products. The current edition is ISO 15378:2017, which applies ISO 9001:2015 and adds good manufacturing practice (GMP) requirements, with one amendment for climate action published in 2024.
This guide is for quality, production and regulatory managers at makers of vials, stoppers, bottles, foils and other packaging that touches the medicine.
What is ISO 15378 and which edition is current?
ISO 15378:2017 is the fourth edition. It was published in September 2017 by ISO technical committee ISO/TC 76 and replaced the 2015 edition. ISO last reviewed and confirmed it in 2023, so it remains current. Amendment 1, "Climate action changes", followed in February 2024, according to the standard's page on iso.org.
ISO describes it as an application standard for the design, manufacture and supply of primary packaging materials. Primary packaging is the packaging in direct contact with the medicine: glass vials and ampoules, rubber closures, plastic bottles, blister films and foils, and similar items. Secondary packaging such as cartons is outside that definition, although printed items can still fall under customer GMP requirements.
One feature catches teams out. Where the standard qualifies a requirement with "if appropriate", ISO treats it as appropriate unless the organisation documents a justification otherwise. In practice, every exclusion you claim needs a written reason an auditor can read.
How does ISO 15378 relate to ISO 9001, and does ISO 9001:2026 change anything?
ISO 15378 is built on ISO 9001. Its full title says it sets particular requirements for applying ISO 9001:2015 with reference to GMP. DQS, a certification body, reports that it incorporates the full text of ISO 9001 and adds the GMP requirements around it. A company that meets ISO 15378 therefore also works to the ISO 9001 structure of clauses 4 to 10.
ISO 9001:2026 was published in September 2026 and ISO now lists ISO 9001:2015 as withdrawn. ISO 15378:2017 has not been revised to follow it. On 2 October 2026 iso.org still listed the 2017 edition as current and showed no new edition in its life cycle. DQS reports that a revision is expected after the next ISO 9001 edition, but no date has been announced.
So for now, ISO 15378 certification continues against the 2017 edition. If you hold a separate ISO 9001 certificate as well, that one moves to the 2026 edition on your certification body's transition plan. Our ISO 9001:2026 transition guide covers what changed. Ask your certification body how it will handle ISO 15378 audits while its base edition is withdrawn.
Who should use ISO 15378?
The standard fits any organisation whose product ends up in contact with a medicinal product. That includes glass converters, rubber and elastomer moulders, plastic bottle and closure makers, and producers of blister films, laminates and aluminium foil. It also suits printers of primary packaging, such as printed foil for blister lidding.
Many suppliers adopt it because their pharmaceutical customers ask for it in supplier questionnaires and quality agreements. ISO 15378 is a voluntary standard, not a law. The legal GMP duties sit with the medicine manufacturer, which then passes them to you through specifications, audits and contracts.
Some packaging suppliers also hold BRCGS Packaging Materials certification. Our guide to running BRCGS Issue 7 and ISO 15378 together explains how the two overlap.
What do pharmaceutical GMP rules expect from packaging suppliers?
Your customers answer to GMP regulators, and their obligations shape what they ask of you. Two examples are the US drug GMP regulations in 21 CFR Part 211 and Chapter 5 of the EU GMP Guide, whose current version came into operation on 1 March 2015. The table summarises the parts that reach packaging suppliers. The right-hand column is AGS's interpretation, not regulatory text.
| Requirement on the medicine maker | What it says, in summary | What the packaging supplier is usually asked for |
|---|---|---|
| 21 CFR 211.84(d)(3) | Containers and closures must be tested against written specifications. The drug maker may accept the supplier's certificate of testing if it does at least a visual identification and checks the reliability of the supplier's results at intervals. | Reliable certificates of analysis, test methods that match the agreed specification, and test records available for audit |
| 21 CFR 211.94 | Containers and closures must not react with, add to or absorb the drug. They must protect it, be clean, and where needed be sterilised and depyrogenated by a validated process. | Material and extractables data, cleaning controls, and validation reports for any sterilisation or depyrogenation you perform |
| EU GMP Chapter 5, 5.45 | Suppliers of primary and printed packaging must be selected, qualified and approved with attention similar to suppliers of starting materials. | Supplier questionnaires, customer audits, quality agreements and change notification |
| EU GMP Chapter 5, 5.46 | Printed packaging must be stored securely, and loose printed items kept in separate closed containers to avoid mix-ups. | Secure print storage, artwork and plate control, line clearance and label reconciliation records |
The US text is on the eCFR page for 21 CFR Part 211. EU GMP chapters are published in EudraLex Volume 4 by the European Commission.
What will an auditor ask to see at a packaging plant?
A certification auditor checks the system against ISO 15378. A customer auditor checks whether your plant can supply their product without risk. Both look for the same evidence on the shop floor. The list below is AGS's practical view, not a quote from the standard.
- Line clearance: a signed check before each job that the line holds no material, print or documents from the previous one.
- Printed components: controlled issue of labels and printed foil, counts in and out, and investigation of any reconciliation difference.
- Environment: cleanroom or controlled-area classification where you have one, with temperature, humidity and particle monitoring records.
- Hygiene and pests: gowning rules, cleaning records, pest control reports and a glass and brittle plastics policy.
- Change control: a record of every change to material, process, equipment or site, with evidence the customer was told before the change where the quality agreement requires it.
- Deviations and CAPA: investigations that reach a root cause, with actions closed and checked for effect.
- Data integrity: batch records and test results that are attributable, legible, contemporaneous, original and accurate.
Expect the auditor to pick one batch and trace it from incoming resin, glass or foil through production, inspection and release to the shipment. Gaps usually show up where two departments hand over records.
How is ISO 15378 certification obtained and maintained?
A certification body audits the system and issues the certificate. ISO does not certify companies itself. DQS reports the usual pattern: a stage 1 review of documents and readiness, a stage 2 audit on site, then annual surveillance audits and a recertification audit at the end of a three-year cycle.
Before stage 1, run the system long enough to produce real records. That means at least one round of internal audits across all clauses, a management review, and closed corrective actions. Check that the certification body's accreditation covers ISO 15378, and agree the scope wording with it early. Your scope should name the packaging types and processes you supply.
How AGS can help
The ISO 15378 Management System kit contains 90 editable documents in Microsoft Word, plus an Excel compliance matrix for ISO 15378:2017. It includes a quality manual, a quality plan, 21 procedures such as traceability, CAPA, risk management and sterilisation validation, and 40 forms and records. Its 12 checklists cover internal audit for clauses 4 to 10, GMP compliance, line clearance and data integrity.
Frequently asked questions
Is ISO 15378 mandatory for pharmaceutical packaging suppliers?
No. It is a voluntary standard. Customers often ask for it, but whether you need it depends on their supplier requirements and your quality agreements.
Does an ISO 15378 certificate replace an ISO 9001 certificate?
ISO 15378 applies the ISO 9001:2015 requirements and adds GMP. Whether a customer accepts it in place of an ISO 9001 certificate depends on its supplier requirements, so check the wording of your quality agreement.
Does ISO 15378 apply to secondary packaging such as cartons?
Its scope is primary packaging materials. Printed secondary items are usually controlled through the medicine maker's own GMP requirements and your agreement with that customer.
Will buying documents get my plant certified?
No. Documents are a starting point. Certification depends on how the system runs and on the certification body's audit findings.
AGS provides independent documentation toolkits. This guide and the referenced kit are not affiliated with, endorsed by or approved by ISO, the US Food and Drug Administration, the European Commission or any certification body. They do not guarantee any audit or certification outcome.
Reviewed October 2026. Facts checked against the sources current at publication.
