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Standard operating procedures revisited: a 2014 perspective

By: A. Kanarek
Reprinted with permission of Pharmaceutical Bioprocessing, February 2014

Regrettably, the publishers of Pharmaceutical Bioprocess do not allow the posting of reprints from their journal. Therefore, we provide here a link to the publisher’s website where the article can be found.

Approximately 50 years after the good manufacturing practice (GMP) regulations were first issued, regulatory inspections of firms operating under GMP are still uncovering cases of non-compliance with the rules concerning written operating procedures and the need to follow them. These rules are fundamental to GMP and are simple to understand. Future changes to GMP will emphasize risk management and the need to have an effective quality culture in the firm. SOPs will still form an essential part of the quality system. This article examines the principal problem areas in standard operating procedure management and provides recommendations for correcting them.