Description
This guidance provides recommendations on what documentation to submit to support the chemistry, manufacturing, and controls (CMC) information for fermentation-derived intermediates, drug substances, and related drug products for veterinary medicinal use. This information is filed to the Center for Veterinary Medicine (CVM) in a new animal drug application (NADA), conditional new animal drug application (CNADA), investigational new animal drug file (INAD), abbreviated new animal drug application (ANADA), generic investigational new animal drug file (JINAD), drug master file (DMF), or veterinary master file (VMF).
Scope & Applicability
Product Classes
5Subject of the guidance document
For fermentation-derived drug products, an expiration date should be established
When an expiration date is assigned to a fermentation-derived intermediate
Scope of the analytical procedures
Scope of the analytical procedures
Stakeholders
1responsible for justifying omission of studies
Regulatory Context
Attributes
5should be based on appropriate supportive stability data
retest date should include those test attributes critical to the fermentation-derived intermediate (e.g., potency, moisture content)
marked change or trend in the potency and/or degradation profile
Key search term and scientific factor for evaluation.
conclusions regarding appropriate storage conditions and an appropriate retest or expiration date; a retest date allows for use of a material beyond the retest date
Identified Hazards
Hazards
4Microbial systems can introduce variability affecting purity and quality
Transmission of adventitious agents is a key issue in human- and animal-derived materials.; Human- and animal-derived materials increase the risk of introducing adventitious agents
Information concerning impurities in the fermentation-derived intermediate
Information concerning impurities in the fermentation-derived intermediate
Related CFR Sections (2)
- 21CFR514.1§ 514.1 Applications.
(a) Applications to be filed under section 512(b) of the act shall be submitted in the form and contain the information described in paragraph (b) of this section, as appropriate to support the particular submission. If any part of the application is in a foreign language, an accurate and complete ERead full regulation →
- 21CFR514.8§ 514.8 Supplements and other changes to an approved application.
(a) Definitions.Read full regulation →
See Also (7)
- CVM GFI #176 (VICH GL39) Specifications: Test Procedures and Acceptance Criteria for New Veterinary Drug Substances and New Medicinal Products: Chemical Substances (Status: Final)
- CVM GFI #255 Elemental Impurities in Animal Drug Products Questions and Answers (Status: Final)
- CVM GFI #106 The Use of Published Literature in Support of New Animal Drug Approvals (Status: Final)
- CVM GFI #227 Chemistry, Manufacturing, and Controls (CMC) Technical Section Filing Strategies (Status: Draft)
- CVM GFI #187B Heritable Intentional Genomic Alterations in Animals: The Approval Process (Status: Final)
- CVM GFI #213 New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209 (Status: Final)
- CVM GFI #218 Cell-Based Products for Animal Use (Status: Final)