Iso 15378 - Key Points.pdf | ^hot^

If you are preparing for a certification audit (by a notified body like SGS, LRQA, or DNV), your cheat sheet PDF should help you survive these common audit questions:

It applies to manufacturers of primary packaging materials intended for: ISO 15378 - Key Points.pdf

The first key point found in any summary is the standard’s unique structure. It takes the general business management principles of ISO 9001 and injects the specific, product-safety focus of GMP. If you are preparing for a certification audit

ISO 15378:2017 ("Primary packaging materials for medicinal products – Particular requirements for the application of ISO 9001:2015, with reference to Good Manufacturing Practices (GMP)") is a specific quality management system standard. Establishing robust systems to track materials from raw

Establishing robust systems to track materials from raw state to finished product.

ISO 15378 requires a rigorous design control process. This includes: