PS 9000:2001

The Pharmaceutical Quality Group (PQG) of the Institute of Quality Assurance (IQA) has developed PS 9000:2001 which aims to provide a widely accepted baseline GMP framework of best practice within the pharmaceutical packaging supply industry. It applies ISO 9001:2000 to pharmaceutical printed and contact packaging materials.

PS 9000:2001 is based on, and replaces, the two separate IQA/PQG Pharmaceutical Supplier Codes of Practice (CoP) for contact and printed packaging materials. These Codes of Practice were first issued in 1990 and subsequently revised in 1995. The CoP successfully established a widely accepted baseline GMP framework for suppliers of contact packaging and printed materials. They also formed the basis for a certification scheme that enables suppliers to publicize compliance with the requirements of a specific CoP.

The previous was extracted from the full article which can be found at the IQA Website.

This is only an overview/extract of the standard. Users should not rely on its accuracy, but should refer to the complete standard of the appropriate revision.

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