Pharmaceutical Packaging

ISO 15378 Certification

Independent third-party ISO 15378 certification for manufacturers of primary packaging materials for medicinal products. Meet pharmaceutical customer GMP expectations with one recognized certificate.

Request a Certification Quote Transfer Your Certificate

The Standard

What Is ISO 15378?

ISO 15378:2017 sets requirements for quality management systems at manufacturers of primary packaging materials for medicinal products: the vials, stoppers, closures, blister films, bottles, and bags that come into direct contact with a drug. It applies the full ISO 9001:2015 framework and adds Good Manufacturing Practice (GMP) requirements specific to pharmaceutical packaging.

Certification means an independent certification body has audited your quality system in operation and confirmed it meets the standard, including GMP controls such as contamination prevention, traceability, change control, and validation.

Why Certify

Why Organizations Get ISO 15378 Certified

Qualify as a Pharma Supplier

Drug manufacturers expect primary packaging suppliers to work under GMP. ISO 15378 certification answers that requirement in supplier qualification.

Reduce Customer Audits

A recognized certificate gives pharmaceutical customers documented assurance and can reduce the number and depth of second-party audits.

Control Product Risk

GMP controls for cleanliness, traceability, and change management protect patients and protect your customer relationships.

Builds on ISO 9001, so one management system covers quality and GMP
Fits glass, plastic, rubber, aluminum, film, and paper-based primary packaging manufacturers
Supports pharmaceutical supplier qualification and customer quality agreements

The Process

How ISO 15378 Certification Works

GMCS runs a defined, two-stage certification audit. You always know where you are in the process and what comes next.

1. Quote and applicationTell us your size, sites, and timeline. We scope the audit program and send a proposal.

2. Optional pre-assessmentA readiness audit that finds gaps before the certification audit. Recommended for first-time certifications.

3. Stage 1 auditReview of your documented quality management system and confirmation you are ready for Stage 2.

4. Stage 2 auditThe certification audit: your system evaluated in operation against ISO 15378 requirements.

5. CertificationCertificate issued once any audit findings are closed.

6. Surveillance and recertificationAnnual surveillance audits maintain the certificate; recertification renews it at year three.

Cost

What Determines ISO 15378 Certification Cost

There is no one-size price. Your quote is scoped from audit time, which is driven by four factors. Organizations with fewer than 100 employees qualify for the GMCS Small Organization Program's discounted pricing.

Get a Scoped Quote

Employee countTotal headcount including part-time and contractors sets baseline audit time

Number of sitesEach location in scope adds audit activity

Process complexityScope, risk, and regulated work take longer to audit

Certification pathNew certification, transfer, or recertification each scope differently

Transfers

Already ISO 15378 Certified? Transfer to GMCS.

If your current certification body is slow to schedule, slow to answer, or priced for someone else's overhead, transfer your certificate to GMCS. Your certification cycle and surveillance schedule continue, and in most cases there is no repeat of Stage 1 and Stage 2.

Start a Transfer

Why GMCS for ISO 15378

Certification body accredited by IAS to ISO/IEC 17021-1
Auditors from commercial, government, and regulated environments
Direct access to decision makers, no layers of process
Independent certification only, never a consulting upsell

FAQ

ISO 15378 Certification Questions

Do we need ISO 9001 as well as ISO 15378?

ISO 15378 incorporates the requirements of ISO 9001:2015 and adds GMP requirements for primary packaging. Many suppliers hold ISO 15378 on its own, and GMCS can scope a combined audit if your customers also ask for an ISO 9001 certificate.

Does ISO 15378 replace regulatory GMP inspections?

No. Certification is a voluntary, independent audit of your quality system. It does not replace any inspection or registration a regulator requires, but it demonstrates GMP discipline to customers.

How long does ISO 15378 certification take?

Timing depends on how mature your quality system and GMP controls are. Once they are documented and in operation, certification is a two-stage audit. GMCS scopes your timeline in the quote.

How much does ISO 15378 certification cost?

Cost is driven by organization size, number of sites, and the complexity of your processes. GMCS maintains discounted pricing for organizations with fewer than 100 employees. Request a quote for scoped pricing.

Can we transfer our existing ISO 15378 certificate to GMCS?

In most cases, yes. GMCS reviews your current certificate and audit history, and your certification cycle continues without starting over.

Does GMCS provide ISO 15378 consulting?

No. GMCS is an independent certification body. Certification body rules prohibit certifying a system we helped build, and that independence keeps your certificate credible with customers.

Get Your ISO 15378 Certification Quote

Tell us your organization size, sites, and timeline. We'll scope the audit program and send a proposal, with no consulting upsell.

Request a Certification Quote

Accreditation & Recognition

Credentials You Can Verify

Verify GMCS’s accreditation, scope, and the status of any certificate we issue.