Strict personnel hygiene protocols, including mandatory protective clothing, hairnets, and sanitization procedures.
ISO 15378 applies directly to manufacturers of primary packaging materials that come into direct contact with medicinal products. The Core Integration iso 15378 key pointspdf free
Understanding ISO 15378: Key Points for Pharmaceutical Packaging Strict personnel hygiene protocols
Run the updated system for several months to gather data. Conduct rigorous internal audits led by trained personnel to identify non-conformances. Address these issues through the CAPA system before booking an official audit. Phase 5: Certification Audit including mandatory protective clothing
Robust, documented pest management systems must protect storage and manufacturing zones.