Description
The submission of information regarding components and composition, as well as manufacturing methods, facilities, and controls is required under 21 CFR 514.1(b)(4) and (5) for new animal drug applications and under section 512(n)(1)(G) of the Federal Food, Drug, and Cosmetic Act for abbreviated new animal drug applications. The submission of manufacturing changes to an approved application is required under 21 CFR 514.8(b)(1)(i).
Scope & Applicability
Product Classes
4Scope of the guidance document
The primary product category covered by this guidance; Subject of the bioequivalence guidance for poorly soluble APIs.
New animal drug dosage forms intended for use in the manufacture of medicated feeds; The primary product category discussed for CMC considerations.; manufactured for homogeneity, segregation, and stability studies
Product category subject to user fees
Stakeholders
3Entity responsible for submitting applications under section 524B
Entity responsible for risk assessment and testing
Facility supplying raw materials or ingredients; Facility providing raw materials to a manufacturer
Regulatory Context
Attributes
1Reevaluate the risk throughout the product lifecycle
Identified Hazards
Hazards
1Safety assessment addressed by ICH Q3D
Related CFR Sections (3)
- 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 →
- 21CFR211.84§ 211.84 Testing and approval or rejection of components, drug product containers, and closures.
(a) Each lot of components, drug product containers, and closures shall be withheld from use until the lot has been sampled, tested, or examined, as appropriate, and released for use by the quality control unit.Read full regulation →
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See Also (8)
- CVM GFI #169 Drug Substance Chemistry, Manufacturing, and Controls Information (Status: Final)
- CVM GFI #106 The Use of Published Literature in Support of New Animal Drug Approvals (Status: Final)
- CVM GFI #278 Human User Safety in New and Abbreviated New Animal Drug Applications (Status: Final)
- CVM GFI #292 Chemistry, Manufacturing, and Controls Considerations for Type A Medicated Articles (Status: Draft)
- CVM GFI #227 Chemistry, Manufacturing, and Controls (CMC) Technical Section Filing Strategies (Status: Draft)
- 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 #216 Chemistry, Manufacturing, and Controls (CMC) Information - Fermentation-Derived Intermediates, Drug Substances, and Related Drug Products for Veterinary Medicinal Use (Status: Final)
- CVM GFI #187B Heritable Intentional Genomic Alterations in Animals: The Approval Process (Status: Final)