guidelines. It is specifically designed for manufacturers of primary packaging materials that come into direct contact with medicinal products (e.g., glass vials, rubber stoppers, aluminum foils, plastics). iTeh Standards Key Points of ISO 15378:2017 Integration of ISO 9001 & GMP:
Any software used in the quality system or production line must be validated to ensure data integrity. 5. Traceability and Complete Documentation iso 15378 key pointspdf free
principles required by global regulators like the FDA (U.S.) and European directives. 2. Focus on Primary Packaging Materials guidelines
The standard demands a formal risk management system. You must assess risks related to: Focus on Primary Packaging Materials The standard demands
Visual, functional segregation between raw materials, in-process goods, and released stock
All automated machinery must undergo installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
Implementing rigorous calibration and cleaning schedules to avoid batch cross-contamination. 3. Risk Management