ISO 15378:2015 Primary Packaging Materials For Medicinal Products Certification

ISO 15378:2015 identify needs for a quality management system where an organization requirements to demonstrate its capability to give primary packaging materials for medicinal products, which constantly meet client necessities, including regulatory necessities and International Standards applicable to primary packaging materials.

Now for the question all ISO 15378 users have: What are the changes in the ISO 15378:2015 Edition? Here’s the guidance gives by the committee:

This new edition includes necessities for risk management.

There is an extensive revision regarding verification, qualification and validation necessities for primary packaging materials.

The necessities for infrastructure, work environment, maintenance and cleaning activities have been revised. Also the needs for customer communication control of production and service provision and batch discharge have been customized.


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