ISO 15378 · Primary packaging materials for medicinal products
ISO 15378 certification and requirements for packaging your pharmaceutical customers can approve.
Show pharmaceutical buyers that the containers, closures and components you supply are made under a quality system that applies ISO 9001 with good manufacturing practice. Sterling's expert and experienced consultants build that system with your production, quality and technical teams, prepare the evidence and stay with you through the certification audit, in 60+ countries. We ensure successful certification for our clients.
- Fixed scope, one proposal: consulting, Effivity software, Sterling Academy access and internal auditor training, as applicable to your standard, in one proposal
- A team of expert and experienced quality and GMP consultants, advising on management systems across sectors and countries since 2003
- The Sterling Promise: 100% on-time completion, 100% success, 8,100+ client engagements. Sterling does not certify; an independent certification body audits and decides
8,100+ client engagements in 60+ countries.
Why clients choose Sterling
What it is
What is ISO 15378 and what is it used for?
ISO 15378 is the International Standard for quality management at makers of primary packaging materials for medicinal products. Its full title explains the design: particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP). It takes every ISO 9001 requirement and adds the GMP expectations a pharmaceutical customer places on a packaging supplier, so one system can answer both. ISO describes it as an application standard for the design, manufacture and supply of these materials.
The point is simple. A vial, stopper, blister film or tube becomes part of the medicine the patient receives, so a defect in the packaging can become a defect in the product. Pharmaceutical manufacturers qualify their packaging suppliers accordingly, and ISO 15378 gives both sides a shared, independently audited basis for that qualification, alongside the customer's own supplier audits.
Current edition. ISO 15378:2017, the fourth edition, published in September 2017 and confirmed by ISO in January 2023; Amendment 1:2024, on climate action changes, was published in February 2024. The standard is built on ISO 9001:2015, and ISO 9001 has since moved to its 2026 edition; as at 30 September 2026 ISO lists no new ISO 15378 project. Your certification body confirms how it is handling that difference, and we plan any change with you.
Who it is for
Who needs ISO 15378 certification?
ISO 15378 fits glass, plastic, elastomer, metal and laminate converters, printers of primary packaging and the companies that supply those materials into pharmaceutical supply chains. The certificate scope should name the products, processes and sites your customers actually source from. Packaging suppliers usually come to Sterling for one of four reasons:
- A pharmaceutical customer asks for it. The supplier questionnaire or quality agreement names ISO 15378, or the customer's auditor wants GMP evidence that an ISO 9001 certificate alone does not give. Confirm the expected scope before you invest.
- A tender or new contract lists it. Buyers comparing packaging suppliers use it to shortlist; a credible certificate, with a scope that matches the tender, removes one reason to be screened out.
- Regulators look at your customers' supply chain. Your customers answer to medicines regulators for the packaging they use, and they pass that pressure on through audits, change notifications and complaint handling. A GMP-based system makes those exchanges routine.
- Your group wants one system across plants. A parent company or new owner expects every packaging site to meet the same quality and GMP baseline, with the same records and the same certificate.
The certificate opens the door; your customers' own audits still decide whether you stay on the approved supplier list. The system has to work on the shop floor every day.
Requirements
What are the main ISO 15378 requirements?
ISO 15378 follows the structure of ISO 9001:2015, clauses 4 to 10, with GMP-related particular requirements for primary packaging added within them. The list below is a plain-language map of those clause areas; during the programme your system is checked against the full text of the standard, including every GMP addition.
- Clause 4 Context of the organisation: define the system's scope around the packaging you make, the customers and regulations it serves and the issues that affect it.
- Clause 5 Leadership: top management owns product quality and GMP, sets policy and assigns responsibilities and authority.
- Clause 6 Planning: address risks and opportunities, set quality objectives and plan changes in a controlled way.
- Clause 7 Support: provide trained people, suitable premises, equipment and working environment, calibrated measuring resources and controlled documents and records.
- Clause 8 Operation: control customer requirements, design, purchasing, production, identification and traceability, release and nonconforming product.
- Clause 9 Performance evaluation: monitor processes and product, measure customer satisfaction, run internal audits and hold management reviews.
- Clause 10 Improvement: correct nonconformities, remove their causes and improve the system continually.
What does useful ISO 15378 evidence look like?
Batch records that let you trace any lot back to its raw materials and forward to the customer, line clearance and in-process checks, supplier approvals, calibration and maintenance records, change notifications to customers, complaint investigations, training records and corrective actions shown to be effective. We identify the records your processes genuinely need and set them up in Effivity from the first workshop, so the auditor and your customers see a system in daily use.
Certification process
How do you get ISO 15378 certified?
Implement the quality system first; an independent certification body then audits it. Sterling prepares the system, the people and the evidence. The certification body audits and decides, and keeping those roles apart is what gives your customers confidence in the certificate.
- 01Fix the scope your customers need.Agree the packaging types, processes, sites and customer requirements the certificate must cover, and whether design is included.
- 02Gap analysis: compare current practice with ISO 15378.Walk the production floor, the warehouse and the quality records against the standard, keep what already works and give each action an owner and a date.
- 03Implement the system and produce the records.Put the GMP controls into daily production, train operators, supervisors and quality staff, and let the records build up batch by batch.
- 04Audit internally and review.An internal audit against the full standard and a management review; we raise the findings first and close them on evidence.
- 05Complete the certification audit.The certification body usually runs a Stage 1 readiness review and a Stage 2 audit, then decides; surveillance and recertification follow on its own schedule.
Check the route before you sign. Ask which certification body will audit, whether its accreditation covers ISO 15378 and your scope, and verify both directly with the accreditation body; accreditation recognition runs through the Global ACI arrangement. A certificate your pharmaceutical customer cannot verify will not survive their supplier audit. The certification buyer's checklist
Cost
How much does ISO 15378 certification cost?
No single price fits every packaging plant. A single-site printer that already holds ISO 9001 starts from a very different place from a multi-plant glass or polymer group building GMP controls for the first time. What a Sterling proposal offers is an all-inclusive proposal, with every component shown.
| Cost component | What affects it |
|---|---|
| Consulting and implementation | Current maturity, the number of packaging types, processes and sites, whether design is in scope, and how much of the work your team takes on (Design™ or Drive™) |
| Independent certification | The certification body's audit days, sites, travel and ongoing surveillance, quoted by the body itself |
| Plant and environment changes | Any improvements the gap analysis identifies to production areas, hygiene zoning, equipment or measuring instruments, identified separately |
| Internal resources | Time from production, quality and technical staff for drafting, training, trials and changes on the floor |
| Software and learning | Included in a Sterling engagement: Effivity for the quality system and Sterling Academy access for your people, with users, courses and access period confirmed in the proposal |
Timeline
How long does ISO 15378 certification take?
Most programmes take six to twelve months, as an estimate: nearer the shorter end where a working ISO 9001 system exists, longer where GMP controls, hygiene arrangements or traceability have to be built from the start. The system must run long enough to generate batch records, internal audit results and a management review before the certification body arrives.
| Phase | What determines the pace |
|---|---|
| Scope and gap analysis | Access to the plant, production and quality records, customer agreements and previous audit reports |
| Build and implementation | The extent of documentation, training and any changes to production areas or equipment |
| Evidence and review | Enough production runs to show the controls work, then internal audit and management review |
| Certification audit | The certification body's availability for Stage 1 and Stage 2, and the time needed to close any findings |
Your engagement
What your ISO 15378 engagement includes
Sterling runs ISO 15378 through Sterling OS™, one method from first workshop to certification and beyond. Design™ and Drive™ are two alternative levels of support, and you choose the one that suits your team: with Design™ we guide and your people write and implement; with Drive™ we manage the work and carry more of it ourselves. Either way the scope covers gap analysis, the implementation plan, documentation built on Sterling's own template sets, internal auditor training as applicable to your standard, internal audit, management review and preparation for the certification audit.
After certification, Sustain™ keeps the system working between surveillance audits: internal audits, customer audit support, change control reviews and refresher training. Automate™ is Effivity, where documents, records, audits and actions live from day one, included with the engagement at no additional cost. Your people also receive preferential Sterling Academy access, including complimentary awareness training as part of the engagement.
Sterling does not certify; the independent certification body audits your system and makes the certification decision.
Often combined with
Standards organisations pair with ISO 15378
- 21 CFR Part 11 / EU Annex 1121 CFR Part 11 and Annex 11 compliance for GxP systems: requirements, validation, audit trails and e-signatures, with evidence ready for FDA and EU inspectors.
- ADHICS (Abu Dhabi)ADHICS compliance consulting for DoH-regulated healthcare entities in Abu Dhabi: patient information, systems and devices protected, with audit-ready evidence.
- amfori BSCIamfori BSCI audit preparation for producers: gap assessment across the 13 performance areas, remediation, worker-facing evidence and support from Sterling.
- Better Cotton (BCI)Better Cotton (BCI) Chain of Custody certification for textile suppliers: stock and claim controls, reconciled records, training and audit readiness.
- BRCGS Packaging MaterialsBRCGS Packaging Materials certification explained: Issue 7, GFSI recognition, who asks for it and how Sterling prepares packaging sites for the audit.
- CAP accreditationCAP accreditation readiness for laboratories: checklist gap analysis, method records, self-inspection and peer inspection support.
Effivity · ISO and GRC software, included in every engagement
How Effivity helps you fulfil, automate and simplify the requirements of ISO 15378:2017.
Every Sterling ISO 15378 engagement includes Effivity, the ISO and GRC automation platform built by the Sterling group and used in 50+ countries. Your consultant sets up the quality workspace within the agreed scope, so controlled documents, supplier approvals, nonconformities, customer complaints, change control, calibration, training and management review sit in one place and your pharmaceutical customers' auditors see records created as the work happens. Sterling consulting clients get their Effivity subscription included with the engagement, at no additional cost.
Scope, customers and regulatory expectations
The certificate scope, the issues that shape the business and the pharmaceutical customers and regulations it serves, held in one register and reviewed on a schedule.
Policy, responsibilities and objectives
Quality policy, roles and objectives with owners and dates, reported from live data rather than a separate spreadsheet.
Risks, opportunities and planned change
A register of risks and opportunities with actions and review dates, and changes planned before they reach the production line.
Training, calibration and documents
Competence records for every operator, calibration and maintenance schedules, and documents with versions and approvals so only the current one is in use.
Suppliers, production and release
Supplier approval and evaluation, production and inspection records, lot traceability and release decisions, each created as the work is done.
Internal audit and management review
Audit programmes and findings, customer satisfaction and process measures on dashboards, and a management review that records its decisions.
Complaints, nonconformity and corrective action
Customer complaints and nonconforming product investigated to root cause, with the evidence that each action worked.
Your own forms and reports
Forms, workflows and reports adapted to your plant without code, with customer quality agreements tracked to the processes they affect.
What this means at the audit
Whether the visitor is the certification auditor or a pharmaceutical customer's supplier auditor, the questions are similar: show the complaint log, the open corrective actions, the training records and the last change notified to a customer. In Effivity each answer is a screen with dates, owners and evidence attached. After certification, Sustain™ runs in the same workspace.
In your engagement
- Subscription included with the engagement, at no additional cost
- Configured by your Sterling consultant within the agreed scope
- Your documents, records and registers migrated, not retyped
- Admin and user training for your team
- Modules for EMS, OHSMS, ISMS, FSMS and more when you integrate other standards
Sterling Academy · quality and GMP e-learning
Train the whole plant for ISO 15378, not just the quality office.
Sterling Academy provides e-learning with video lessons, practice checkpoints, a final exam and a numbered Certificate of Completion for each learner. Sterling consulting clients receive preferential Sterling Academy course access and special pricing through their Sterling consultant, including complimentary awareness training for their people as part of the engagement.
- Awareness training for operators, supervisors and staff, with the competence evidence the standard expects
- Internal auditor training for the people who will audit the system, as applicable to your standard, as part of the engagement
- Training status by department, ready for the certification auditor and customer audits
- New starters trained as they join, so records stay current
Keep exploring
Explore more about ISO 15378
ISO 15378 resources
Services for ISO 15378
Why Sterling
Want successful ISO 15378 certification? Come to Sterling.
Packaging suppliers answer to two audiences at once: the certification body and pharmaceutical customers who audit on their own terms. Sterling builds a system that satisfies both, with controls sized to your processes and records your operators can keep without slowing the line.
Quality and GMP in 60+ countries since 2003
Management systems implemented for manufacturers and regulated supply chains across every region we serve, with offices in 21 countries and one engagement team accountable for every site in scope.
All-inclusive proposal
Consulting, Effivity, training and Academy access in one proposal, with certification-body fees shown separately.
Built for the production floor
Procedures, forms and training written for the people running the lines, so GMP becomes habit rather than paperwork.
Expert and experienced consultants
Expert and experienced consultants who understand quality management and GMP, and who build your system properly the first time so the certification audit confirms what already works.
The Sterling Promise
What our ISO 15378 certification success guarantee means
We stay with you until your agreed ISO 15378 certification outcome is achieved, supporting implementation, preparation and the resolution of audit findings. Included software and employee learning turn the investment into lasting capability rather than a certificate on a wall.
The engagement identifies the standard, scope, outcome and responsibilities. Your organisation supplies accurate information and puts the agreed controls into use. The independent certification body assesses conformity and retains its certification decision. Our commitment concerns the agreed certification support, not a promise of every future customer approval or error-free delivery.
FAQs
Frequently asked questions about ISO 15378
Is ISO 15378 certification mandatory for pharmaceutical packaging suppliers?
No. ISO 15378 is a voluntary International Standard, and the demand for it comes from your customers rather than from the standard itself. Pharmaceutical companies often ask for it in supplier questionnaires and quality agreements, so for many packaging makers it works as a condition of doing business.
Do we need ISO 9001 certification as well as ISO 15378?
Usually not as a separate system: ISO 15378 contains the ISO 9001:2015 requirements and adds the GMP-related ones, so one system meets both. Whether you also hold a separate ISO 9001 certificate is a matter to agree with your certification body and your customers.
Is ISO 15378 the same as GMP certification?
No. ISO 15378 is a certifiable quality management standard that applies ISO 9001 with reference to GMP for packaging materials. GMP for medicinal products is set and inspected by medicines regulators, which grant manufacturing licences; an ISO 15378 certificate is issued by a certification body, not by a regulator.
How does ISO 9001:2026 affect ISO 15378 certification?
ISO 15378:2017 remains the current edition and is written around ISO 9001:2015. As at 30 September 2026 ISO lists no new ISO 15378 project, so ask your certification body how it will handle audits and certificates. We review the 2026 changes with you so the system is ready whichever way the standard develops.
Can ISO 15378 cover only some of our sites or product lines?
Yes. The certificate scope names the products, processes and sites included, and it can start with the plant or line that supplies your pharmaceutical customers. Make sure the scope wording matches what customers will check on the certificate, and extend it later as they ask.
Keep exploring
More on ISO 15378 and related standards
More in Consumer goods, textiles & packaging
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