BRCGS Issue 7 + ISO 15378: GMP for Pharmaceutical Packaging and Print
When packaging touches a medicine, it stops being ordinary packaging. A carton, a label, a blister foil or a closure that will sit against a pharmaceutical product must be made with the same discipline, hygiene and traceability as the medicine itself. This guide explains a combined certification scope that unites the BRCGS Global Standard for Packaging Materials (Issue 7) with ISO 15378:2017 to govern the good manufacturing practice (GMP) production of primary pharmaceutical packaging and associated printed materials. It is written for production, quality, engineering and supply-chain professionals at converters and printers serving regulated markets.
What is the combined BRCGS Issue 7 + ISO 15378 scope?
This certification scope brings two respected frameworks together to cover one demanding task: manufacturing packaging that is in direct or potential contact with medicinal products under controlled, hygienic and traceable conditions.
- BRCGS Global Standard for Packaging Materials, Issue 7, provides a retailer- and customer-recognized benchmark for the safe, legal and consistent manufacture of packaging.
- ISO 15378:2017 adds GMP provisions specifically for primary packaging of medicinal products, integrating the requirements of ISO 9001 with pharmaceutical-grade controls.
Together, they create a single audited framework that satisfies both retailer-driven packaging expectations and pharmaceutical GMP obligations — protecting product integrity, patient safety and regulatory compliance in one coherent system.
Who needs it and who it applies to
The combined scope is aimed at converters and printers producing items such as cartons, labels, blister foils, bottles, closures and similar components destined for pharmaceutical and consumer-health markets. Within these organizations it is directly relevant to:
- Production teams running converting and printing operations.
- Quality assurance and quality control staff.
- Engineering and maintenance functions responsible for equipment and environment.
- Supply-chain personnel managing incoming materials and finished-goods dispatch.
Any manufacturer wanting to supply regulated pharmaceutical customers — who increasingly demand both packaging and GMP assurance — is a candidate for this dual certification.
Key benefits of certification
Combining the two frameworks avoids duplicated audits while raising the bar on control. The principal benefits include:
- Reduced risk of recalls caused by contamination, mix-ups or labelling errors.
- Stronger customer confidence, particularly from pharmaceutical buyers with strict qualification programs.
- Streamlined supplier approval, because one audit addresses both packaging and GMP expectations.
- A single, efficient framework rather than two parallel systems.
What's inside the management system
The combined scope draws requirements from both frameworks and weaves them into one system. Core elements include:
- Senior management commitment and a documented quality management system.
- Hazard and risk analysis using a HACCP-style assessment covering physical, chemical, microbiological and product-safety hazards.
- Robust site standards, plant hygiene and contamination control appropriate to safety-critical packaging.
- Product and process control, including rigorous print and artwork management to prevent mix-ups and errors.
- Comprehensive traceability with reconciliation across incoming materials, work in progress and finished goods.
ISO 15378 additionally embeds pharmaceutical GMP principles: validation, change control, deviation management, cleanliness classification where required, and personnel training. These provisions lift ordinary packaging manufacture to the level expected by medicine makers.
The structure and requirements
The BRCGS Standard organizes its requirements around a small number of fundamental clauses — non-negotiable expectations whose failure results in a major finding — supported by a broader set of detailed provisions covering hazard management, the product safety and quality system, site and plant standards, product and process control, and personnel. ISO 15378 layers pharmaceutical GMP over the top, aligning with ISO 9001's process-based management structure.
Together the combined requirements reflect the expectations of regulators and pharmaceutical customers operating under EU GMP, FDA cGMP and comparable regimes. The result maps closely to ISO 9001 while adding the safety-critical rigour the pharmaceutical sector demands, from validated processes to controlled manufacturing environments.
The road to certification
Certification against this combined scope is achieved through independent third-party audit against the defined clauses. The process typically runs:
- Gap analysis — assess current operations against both BRCGS Issue 7 and ISO 15378 to identify shortfalls.
- Implementation — build the integrated quality and GMP system: hazard analysis, site and hygiene standards, print and artwork controls, validation, change control and traceability.
- Operation — run the system and generate the records that demonstrate control across the manufacturing chain.
- Third-party audit — an accredited certification body audits against the clauses, with findings graded by severity.
- Corrective-action closure — non-conformities are addressed and evidence submitted.
- Surveillance and recertification — periodic audits maintain validity and confirm continued conformity.
Achieving this combined certification signals that an organization can supply both regulated pharmaceutical and consumer markets while demonstrating rigorous hygiene, legality, quality and documentation control appropriate to safety-critical primary packaging and print applications for medicinal products worldwide.
How AGS can help
Implementing two frameworks at once is a substantial project, and the documentation burden is where many manufacturers struggle. The AGS BRCGS Issue 7 + ISO 15378 GMP toolkit, part of our Advanced tier, is built precisely for this combined scope. It provides editable manuals, procedures, HACCP-style hazard assessments, print and artwork controls, validation and change-control templates, traceability and reconciliation forms, and compliance matrices that map to both frameworks.
Instead of reconciling two standards clause by clause on your own, your team starts from an integrated, professionally structured document set and tailors it to your site, products and processes. The kit streamlines implementation, reduces the risk of gaps between the two frameworks, and accelerates your readiness for a graded third-party audit. Contact the AGS Compliance Team to bring pharmaceutical-grade packaging discipline within reach.
