The ASTM International committee formerly known as E55 on Pharmaceutical Application of Process Analytical Technology has recently undergone a change in title and scope that reflects the wider intent of its standards developing mission. The committee is now known as E55 on Manufacture of Pharmaceutical Products.
Along with the title change, the ASTM Committee on Technical Committee Operations also approved a change in scope for E55. The new scope reads as follows:
“The scope of the Committee shall be development of standardized nomenclature and definitions of terms, recommended practices, guides, test methods, specifications, and performance standards for the manufacture of pharmaceutical products. The Committee will encourage research in this field and sponsor symposia, workshops and publications to facilitate the development of such standards. The Committee will promote liaison with other ASTM Committees and other organizations with mutual interests.”
These changes are meant to reflect the intent of Committee E55 to be more inclusive of all the tools, instrumentation and sciences that might be used by the industry in the management of pharmaceutical manufacturing processes.
Committee E55 was formed in 2003. The changes to the title and scope of the committee were the result of a review and evaluation of the committee’s direction and objectives. Another action that led to the changes was the addition of Subcommittee E55.03 on General Pharmaceutical Standards in 2005. The subcommittee currently has the following work items under its jurisdiction:
• WK9864, Guide to a Science and Risk-Based Approach to Qualification of Biopharmaceutical and Pharmaceutical Manufacturing Systems;
• WK9935, Guide for the Application of Continuous Quality Verification to Pharmaceutical Manufacturing;
• WK9936, Practice for Qualification of Basket and Paddle Dissolution Apparatus; and
• WK11898, On-line Total Organic Carbon (TOC) Method Validation in Pharmaceutical Waters. //
Technical Information: Donald Marlowe, U.S. Food and Drug Administration, Rockville, Md.
ASTM Staff: Pat Picariello
November Committee Week