Iso 15378 Key Pointspdf Free New! May 2026

ISO 15378:2017 is a specialized standard that combines ISO 9001 requirements with Good Manufacturing Practices (GMP). It is designed specifically for manufacturers of primary packaging materials for medicinal products. 🎯 The Core Objective

Leadership & responsibility

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Key Points of ISO 15378

ISO 15378 — Concise Guide (Key Points)

What it is

ISO 15378 specifies requirements for a Quality Management System (QMS) where an organization needs to demonstrate the ability to provide primary packaging materials for medicinal products that consistently meet customer and regulatory requirements.
It aligns with ISO 9001:2015 and adds specific requirements for the pharmaceutical packaging environment (safety, regulatory, product quality).

Injection molding of caps (temperature, pressure).
Washing and siliconization of rubber stoppers.
Sterilization (if packaging claims sterility).
Documentation: IQ (Installation), OQ (Operational), PQ (Performance) qualification.