BRCGS Issue 7+ISO 153782017-(GMP)

This certification scope combines 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. Its purpose is to ensure that packaging in direct or potential contact with medicinal products is manufactured under controlled, hygienic and traceable conditions that protect product integrity, patient safety and regulatory compliance. The scope applies to converters and printers producing cartons, labels, blister foils, bottles, closures and similar items, and is relevant to production, quality, engineering and supply-chain personnel. Key requirements draw from both frameworks: senior management commitment and a documented quality management system; hazard and risk analysis (HACCP-style assessment) covering physical, chemical, microbiological and product-safety hazards; robust site standards, plant hygiene and contamination control; product and process control including print and artwork management to prevent mix-ups and errors; and comprehensive traceability with reconciliation across incoming materials, work in progress and finished goods. ISO 15378 additionally embeds GMP principles aligned with pharmaceutical expectations, including validation, change control, deviation management, cleanliness classification where required, and personnel training. The combined standard maps closely to ISO 9001 process-based management and reflects the expectations of regulators and pharmaceutical customers operating under EU GMP, FDA cGMP and comparable regimes. Its main benefits include reduced risk of recalls, stronger customer confidence, streamlined supplier approval, and a single audited framework satisfying both retailer-driven packaging expectations and pharmaceutical GMP obligations. Certification is achieved through independent third-party audit against defined clauses, with graded findings, corrective-action closure and periodic surveillance or recertification audits to maintain validity. Achieving this combined certification signals that an organisation can supply 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.

Included: 117 ready-to-use, fully editable documents (manual, procedures, forms, records, checklists, guidance and training material).

License: single-organization license; delivered electronically as a ZIP archive.