Use of Standards at CBER: New Draft Guidance
Posted 18 December 2017 | By
The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) on Monday released draft guidance offering recommendations on the use of standards in product development and the use of such standards in CBER’s managed review process.
The draft describes how standards are developed, the benefits of using standards and CBER’s policy on accepting standards used in regulatory submissions.
Questions and answers contained within the draft range from the basics (“What is a Standard?” and “How do Standards Differ from Regulations?”) to the more complex (“What is CBER’s Policy on Use of Standards in Regulatory Submissions?” and “Does CBER take Accreditation Standards into Consideration when Assessing Compliance with CBER Regulatory Requirements?”).
For those considering the use of a standard in support of a regulatory application, CBER recommends the following:
“1. When using a standard, the sponsor should provide a complete reference for the standard in the regulatory submission.
2. Note that, once CBER has determined that a version of a standard is acceptable, the sponsor should not implement a new version of that standard before discussing with the product office.
3. Written/Documentary Standards: A sponsor may use appropriate written/documentary standards that describe a process or assay used to assess a manufacturing intermediate or final product.
4. Reference Materials/Physical Standards: A sponsor may also utilize an appropriate physical standard or reference material in the development and testing of their product. Examples of reference materials include commercially supplied reference standards obtained from a reputable commercial source; other materials of documented purity certified by an analytical laboratory or other noncommercial establishment; and a well-characterized lot of the product itself.”
Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research: Draft Guidance for Industry and Food and Drug Administration Staff