ISO 15378-2017 Management System

ISO 15378:2017 specifies requirements for a quality management system applying good manufacturing practice (GMP) to the production of primary packaging materials for medicinal products. Its purpose is to ensure that materials in direct contact with pharmaceutical products, such as glass, plastic, aluminium and elastomeric components, are manufactured under controlled and hygienic conditions that protect product quality and patient safety. The standard integrates the full requirements of ISO 9001 with specific GMP provisions relevant to primary packaging, making it applicable to manufacturers and converters supplying the pharmaceutical industry, and relevant to quality, production, engineering, hygiene and regulatory personnel. Key requirements combine the ISO 9001 process approach and management-system framework with GMP principles including contamination and cross-contamination control, cleanliness and defined manufacturing environments, personnel hygiene and training, and rigorous documentation. It emphasises risk management, validation of processes and equipment, change control, deviation handling, and comprehensive traceability and reconciliation of materials from receipt through production to dispatch. Controls over product and process, printing and artwork where applicable, and management of non-conforming material help prevent mix-ups, errors and defects that could compromise the medicinal products the packaging protects. ISO 15378 aligns with pharmaceutical GMP expectations set by authorities such as the FDA and EMA and complements customer supplier-qualification programmes, bridging general quality management and sector-specific regulatory demands. Its main benefits include a single certifiable framework that satisfies both ISO 9001 and GMP expectations, reduced audit duplication, stronger customer and regulatory confidence, and demonstrable control over safety-critical packaging. Certification is achieved through independent third-party audit by an accredited certification body, with non-conformities requiring corrective action and closure; certificates are maintained through periodic surveillance and recertification audits. Achieving ISO 15378 certification signals that an organisation can reliably supply primary packaging to the regulated pharmaceutical market with the discipline, hygiene and traceability that medicinal-product safety demands.

Included: 78 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.