FDA Releases Guidance on Standards Related to Pharmaceutical Quality
The program aims to aid submissions from external stakeholders and FDA staff.
Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - © Artur - stock.adobe.com
On July 26, 2023, FDA released a guidance document on a program at FDA’s Center for Drug Evaluation and Research (CDER) to publicize a listing of accepted voluntary consensus standards that related to pharmaceutical quality. FDA wrote that its involvement in the development and use of technical consensus standards has been crucial to its mission. FDA has used its standards to “develop and/or evaluate performance characteristics of dosage forms, testing methodologies, manufacturing practices, product standards, scientific protocols, ingredient specifications, labeling of drug products, and other technical or policy criteria.”
The guidance document highlights the scope and purpose of the program, before going through the specific elements of the program, including openness, balance, due process, appeals process, and consensus. The document then addresses CDER’s policies and procedures for evaluating voluntary consensus standards, which are recognition request submission and communication with requestors, recognition request evaluation, and updating the CDER program’s recognized standards database. The document ends with a Q&A section, addressing queries such as where recognized standards are posted and how the CDER program will affect other FDA centers.
The CDER program aids submissions by external stakeholders and FDA staff who are proposing voluntary consensus standards that relate to pharmaceutical quality for recognition. In the document, FDA wrote, “CDER believes that this program will help promote beneficial innovation in pharmaceutical development and manufacturing and streamline the preparation and assessment of marketing applications for products regulated by CDER.”
If an industry stakeholder references one of CDER’s accepted voluntary consensus standards with a product regulated by CDER, FDA may still request additional information to show that the standard was observed and is correct for the intended purpose. FDA wrote that the stakeholder’s use of a recognized standard is strictly voluntary.
Source: FDA
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
AES Clean Technology Launches Next-Generation OSM Utility Solution for Cleanrooms at INTERPHEX 2025
April 2nd 2025Officially launched at INTERPHEX 2025, the Omni ASCENT is a next-generation off-site manufactured vertical utility solution that offers optimized cleanroom flexibility and efficiency.
