Excipient GMP Quality Standards: One is Enough

the International Pharmaceutical Excipients Council (IPEC) updated its 1995 Good Manufacturing Practices Guide for Bulk Pharmaceutical Excipients to incorporate ISO 9000:2000 requirements.Recently, the Institute of Quality Assurance/ Pharmaceutical Quality Group (IQA/PQG) proposed the pharmaceutical excipients application standard PS 9000:2002, which introduces three levels of increasingly stringent quality system requirements. However, the author argues that the additional set of GMP requirements is not necessary and, in fact,will result o­nly in increased complexity for excipient manufacturers.

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