PS 9000:2001 - Pharmaceutical Packaging Materials
This standard sets a widely accepted baseline Good Manufacturing Practice (GMP) framework for the pharmaceutical packaging supply industry to ensure that medicines are packaged to consistently high levels of quality.
The Pharmaceutical Quality Group (PQG) of the CQI has developed PS 9000:2001 in consultation with experts from the pharmaceutical industry.
This standard is the first of a new type of code of practice, which aims to provide a widely accepted baseline GMP framework of best practice within the pharmaceutical packaging supply industry. It applies ISO 9001: 2000 and ISO 9004:2000 to pharmaceutical printed and contact packaging materials.
PS 9000:2001 is based on and replaces the two separate CQI/PQG Pharmaceutical Supplier Codes of Practice (CoP) for contact and printed packaging materials, which were first issued in 1990 and revised in 1995. These 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 publicise compliance with the requirements of a specific CoP. More than 65 European suppliers have taken the opportunity to extend the scope of their ISO 9001/2 certification in this way.
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