Any process affecting product quality must be validated. Common examples:
GMP for packaging requires a cultural shift. ISO 15378 dedicates significant attention to human factors because primary packaging is often handled in cleanrooms. iso 15378 key pointspdf free
At its core, ISO 15378 is an . This means it contains all the requirements of ISO 9001 (such as customer focus, leadership, and process management) and adds specific GMP requirements relevant to primary packaging. The standard harmonizes the general quality management approach of ISO 9001 with the specific regulatory and safety principles of GMP into a single, cohesive set of requirements. Any process affecting product quality must be validated
While the full ISO 15378 standard is a copyrighted, paid document, many certification bodies and industry consultants provide summarizing the key requirements. At its core, ISO 15378 is an
Detailed instructions for critical processes. Batch Records: Documented history of every production run.