scope:

There is an increasing importance placed on those who are involved in the manufacture of pharmaceuticals to produce packaged medicines to a consistently high standard. PS 9000 Pharmaceutical packaging materials is an application standard that contains 'additional particular requirements' derived from Good Manufacturing Practice. It has been developed by the Pharmaceutical Quality Group of the Institute of Quality Assurance in consultation with experts from the pharmaceutical industry. It includes the requirements text of BS EN ISO 9001:2000 and the guidelines text of BS EN ISO 9004:2000.