PS 9000:2016 (Downloadable)


PS 9000:2016 is an application standard developed by the PQG with IPAC-RS to define specific requirements and guidance for Good Manufacturing Practice relating to the manufacture of packaging materials for medicinal products, including orally inhaled and nasal drug products.  This document was updated and revised in July 2016 and is aligned with the structure of ISO 9001:2015. The revised standard is available in two forms: 1. As an A5 printed book from the appropriate standards page. 2. In active PDF format available from this page.


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