BRCGS Packaging Issue 7 & ISO 15378:2017 GMP

This system joins the BRCGS Global Standard for Packaging Materials, Issue 7, to ISO 15378:2017, so one site can govern good manufacturing practice across primary pharmaceutical packaging and the printed materials that go with it. It is written for converters and printers making cartons, labels, blister foils, bottles and closures — packaging in direct or potential contact with a medicinal product, made under controlled, hygienic and traceable conditions that protect product integrity and patient safety.

The BRCGS side carries senior management commitment, a documented product safety and quality management system, and HACCP-style hazard analysis across physical, chemical, microbiological and product-safety hazards, with site standards, plant hygiene and contamination control, product and process control including print and artwork management, and reconciliation from incoming materials through work in progress to finished goods. ISO 15378:2017 lays the pharmaceutical GMP layer over the ISO 9001 process approach: validation, change control, deviation management, cleanliness classification where required and personnel training. Between them they answer what retailers, pharmaceutical customers and regulators working to EU GMP, FDA cGMP and comparable regimes expect of a packaging supplier, each scheme mapped to its own clause structure so one body of evidence serves twice.