Pharmaceutical Standards Development

Indianapolis, IN (October 2013)  Richard Van Doel and Brian Zylla attended the American Society for Testing and Materials (ASTM) Manufacture of Pharmaceutical Products E55 technical committee October 16 and 17.

ASTM International technical committee E55  on Manufacture of Pharmaceutical Products is composed of three key technical subcommittees. These include, E55.01 PAT System Management, Implementation and Practice, E55.03 General Pharmaceutical Standards and E55.04 General Biopharmaceutical Standards.  During the two-day period, Richard and Brian had the opportunity to work directly with other industry leaders in a collaborative environment to develop consensus standards that will shape the future of pharmaceutical manufacturing.  Additionally, E55 members participated in a planning session, which reviewed standards that either are under development or approved versus projected future industry needs.  The outcome from this discussion identified a number of high priority standards that will be developed in 2014.

Consensus standards are different from guidance documents in that the standards are developed by industry for industry and according to OMB Circular A-119 revised, are required to be used:

All federal agencies must use voluntary consensus standards in lieu of government-unique standards in their procurement and regulatory activities, except where inconsistent with law or otherwise impractical.

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