ISO 15378 Management System

ISO 15378 defines a quality management system that applies good manufacturing practice to the manufacture of primary packaging materials for medicinal products: glass containers, plastic components, aluminium foils and rubber closures, all in direct contact with medicine. The standard incorporates the requirements of ISO 9001 and augments them with GMP provisions tailored to primary packaging, so an organisation that manufactures, converts or supplies packaging to the pharmaceutical sector runs a single system answering both general quality management and sector-specific regulatory demand.

What shapes this build is evidence. Internal audit questioning is arranged along the clause structure of the standard, from context of the organisation and leadership through planning, support, operation, performance evaluation and improvement, while a compliance matrix for the 2017 edition maps requirements onto the documents that answer them. Data integrity is treated in its own right through ALCOA principles and good documentation practice, alongside GMP compliance checking, supplier evaluation and line clearance. Beneath that sit the disciplines the standard demands: risk management, contamination and cross-contamination control, controlled manufacturing environments, personnel hygiene and competence, validation of processes and equipment, change control, deviation and non-conformance management, end-to-end traceability with material reconciliation, and control of printing and artwork against mix-ups and labelling errors. Regulators including the EMA and FDA hold the GMP expectations it aligns with, and certification comes from an accredited certification body, graded non-conformities closed out and validity held through surveillance and recertification.