Strict measures must be in place to reduce contamination, including: (clothing, gloves, behavior). Cleaning of machinery and environmental surfaces.
is defined as packaging that comes into direct contact with the medicinal product. This includes materials made from glass, rubber, plastic, aluminium, foils, laminates, and various containers and components. As a result, manufacturers of these materials are the primary users of ISO 15378, though the requirements are generic and applicable to any organization regardless of its type, size, or the products and services it provides.
Provides an essential guide to the standard's components. iso 15378 key pointspdf free
Every raw material lot must receive a unique identifier tracked from receipt through final shipping.
ISO 15378 Key Points: A Comprehensive Guide to Pharmaceutical Packaging Standards (PDF Free) Strict measures must be in place to reduce
Explaining the for specific materials like glass or plastic.
Serves as a "license to play" in the global pharmaceutical supply chain. This includes materials made from glass, rubber, plastic,
While the full standard is a paid document from ISO, you can find useful summaries and "key points" PDFs on various certification body websites.