Description
This guidance describes a program at FDA’s Center for Drug Evaluation and Research (CDER) to make public a comprehensive listing of recognized voluntary consensus standards related to pharmaceutical quality. FDA’s participation in the development and use of technical voluntary consensus standards has been integral to the execution of FDA’s mission. For example, FDA has used such 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.
Scope & Applicability
Product Classes
1Products combining drug, device, or biological constituents; Generally recommended for Enhanced Documentation; Requires 14971-based framework incorporating ICH Q9; A drug-device combination where the device constituent part detects ingestion.
Stakeholders
5SDOs develop or adopt voluntary consensus standards
Proposing voluntary consensus standards for recognition
Coordination and advisory group for FDA's participation in standards activities.
Standards Development Organizations submitting recognition requests
entity submitting marketing applications
Regulatory Context
Attributes
3Key search term and scientific factor for evaluation.
Scope of the voluntary consensus standards
Key tests for vaccine purity should be validated
Related CFR Sections (5)
- 21CFR211.194§ 211.194 Laboratory records.
(a) Laboratory records shall include complete data derived from all tests necessary to assure compliance with established specifications and standards, including examinations and assays, as follows:Read full regulation →
- 21CFR314.70§ 314.70 Supplements and other changes to an approved NDA.
(a) Changes to an approved NDA.Read full regulation →
- 21CFR314.97§ 314.97 Supplements and other changes to an approved ANDA.
(a) General requirements. The applicant must comply with the requirements of §§ 314.70 and 314.71 regarding the submission of supplemental ANDAs and other changes to an approved ANDA.Read full regulation →
- 21CFR601.12§ 601.12 Changes to an approved application.
(a) General.Read full regulation →
- 21CFR211.180§ 211.180 General requirements.
(a) Any production, control, or distribution record that is required to be maintained in compliance with this part and is specifically associated with a batch of a drug product shall be retained for at least 1 year after the expiration date of the batch or, in the case of certain OTC drug products lRead full regulation →
See Also (8)
- Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice: Guidance for Industry (Status: Final)
- Residual Solvents in Drug Products Marketed in the United States: Guidance for Industry (Status: Final)
- Potency Tests for Cellular and Gene Therapy Products: Final Guidance for Industry: (Status: Final)
- Analytical Procedures and Methods Validation for Drugs and Biologics (Status: Final)
- Microbiological Quality Considerations in Non-Sterile Drug Manufacturing: Draft Guidance for Industry (Status: Draft)
- Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting Viral Pathogens (Status: Draft)
- Potency Assurance for Cellular and Gene Therapy Products (Status: Draft)
- Postapproval Changes to Drug Substances Guidance for Industry (Status: Draft)