FDA Releases Guidance on Standards Related to Pharmaceutical Quality

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