ISO 15378 Management System

ISO 15378 defines the requirements for a quality management system that applies good manufacturing practice (GMP) to the manufacture of primary packaging materials for medicinal products. Its purpose is to protect the safety and quality of pharmaceutical products by ensuring that packaging materials making direct contact with medicines, including glass containers, plastic components, aluminium foils and rubber closures, are produced under controlled, hygienic and traceable conditions. The standard is applicable to organisations that manufacture, convert or supply primary packaging to the pharmaceutical sector, and it is relevant to quality assurance, production, engineering, hygiene and regulatory staff. A distinctive feature of ISO 15378 is that it incorporates the requirements of ISO 9001 and augments them with GMP-specific provisions tailored to primary packaging. Key requirements include a documented quality management system with management commitment and continual improvement; risk management; contamination and cross-contamination control; cleanliness and controlled manufacturing environments; personnel hygiene, competence and training; and thorough documentation. The standard requires validation of processes and equipment, change control, deviation and non-conformance management, and end-to-end traceability with material reconciliation from incoming goods through production to dispatch, alongside control of printing and artwork where relevant to prevent mix-ups and labelling errors. ISO 15378 aligns with pharmaceutical GMP expectations enforced by regulators such as the EMA and FDA and supports the supplier-qualification requirements of pharmaceutical customers, effectively bridging generic quality management with sector-specific regulatory demands. Its main benefits include a unified, auditable framework satisfying both ISO 9001 and GMP, reduced duplication of audits, enhanced regulatory and customer confidence, and demonstrable control of safety-critical packaging processes. Certification is obtained through independent third-party audit by an accredited certification body, with graded non-conformities requiring corrective action and closure; ongoing validity is maintained through scheduled surveillance and recertification audits, confirming continued conformity and reliable supply to the regulated pharmaceutical market.

Included: 91 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.