Consensus Standards


The Center for Drug Evaluation and Research (CDER) releases the CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality Guidance for Industry draft guidance for comment.

This proposed guidance will address how CDER will informally recognize volunatry consensus standards. Historically concensus standards have been recognized and required to be used through the OMB Circular A-119. This circular established policy on Federal use of voluntary consensus standards.

ASTM develops standards following the five elements identified in OMB which includes Openess, Balance, Due Process, Appeals Process, and Concensus. From ASTM:

Standards development work begins when members of an ASTM technical committee identify a need or other interested parties approach the committee (see answer above). Task group members prepare a draft standard, known as a work item, which is reviewed by its parent subcommittee through an electronic balloting system. After the subcommittee approves the document, it is submitted concurrently to the main committee and our entire membership.

All negative votes cast during the balloting process, which must include a written explanation of the voters. objections, must be fully considered before the document can be submitted to the next level in the process. Final approval of a standard depends on concurrence by our standing Committee on Standards that proper procedures were followed and due process was achieved.

ASTM Committee E55 on Manufacture of Pharmaceutical and Biopharmaceutial Products have developed many voluntary consensus standards notably:
E2500-13 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
E2537-16 Standard Guide for Application of Continuous Process Verification to Pharmaceutical and Biopharmaceutical Manufacturing
E3051-16 Standard Guide for Specification, Design, Verification, and Application of Single-Use Systems in Pharmaceutical and Biopharmaceutical Manufacturing among others.

Bryan Zylla and Richard Van Doel of Performance Validation are members of ASTM E55 committee and participate in the development, review and approval of standards. Are you interested in participating in development the next generation standards applicable to the Pharmaceutical Industry? If so contact Rick Van Doel for additional info or check out how to join ASTM at the Membership Link.

E2537-16 Standard Guide for Application of Continuous Process Verification to Pharmaceutical and Biopharmaceutical Manufacturing