Description
The Chemistry, Manufacturing, and Controls (CMC) technical section is one portion of an original new animal drug application (NADA), abbreviated new animal drug application (ANADA), conditional new animal drug application (CNADA) and must contain full information regarding the manufacture of the new animal drug substance and new animal drug product. Animal drug manufacturing processes must be robust and able to produce drug product batches of consistent identity, strength, quality, and purity. Primary batches of drug product are manufactured as part of the original application. Data from these batches are used to establish that the manufacturing, sampling, and control processes described in the CMC portion of the application will consistently provide a quality, stable drug product that, within a batch and on a batch-to-batch basis, does not vary beyond the established specification(s). Additionally, they are used in studies to establish that the drug product is safe and effective (or in the case of an ANADA, bioequivalent to the reference listed new animal drug). As such, the primary batches demonstrate that the applicant can consistently manufacture batches of same quality as those used in safety and effectiveness (or bioequivalence) studies. This guidance provides recommendations for the primary batches of drug product manufactured to support the approval or conditional approval of new animal drug products.
Scope & Applicability
Product Classes
1Animal drugs intended for a minor use or a minor species
Stakeholders
1Division of Manufacturing Technologies
Regulatory Context
Attributes
1Impurity profile, polymorphism, particle size
Related CFR Sections (1)
- 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 →
Related Warning Letters (10)
- 2025-12-23
CGMP/Finished Pharmaceuticals/Adulterated
SV Labs Corporation
- 2025-12-23
CGMP/Finished Pharmaceuticals/Adulterated
Guangdong Renhe Guozhuang Biotechnology Co., Ltd.
- 2025-12-23
CGMP/Finished Pharmaceuticals/Adulterated
Medinatura New Mexico, Inc.
- 2025-12-16
CGMP/Finished Pharmaceuticals/Adulterated
Sklar Personal Care Inc.
- 2025-12-16
CGMP/Deviations/Biologics License Application (BLA)
Microvascular Tissue, Inc.
- 2025-12-11
CGMP/Finished Pharmaceuticals/Adulterated
Catalent Indiana, LLC
- 2025-12-09
CGMP/Finished Pharmaceuticals/Adulterated
DeVere Manufacturing Inc.
- 2025-12-09
CGMP/Finished Pharmaceuticals/Adulterated
CDL Services, Inc. DBA Technichem
- 2025-12-09
CGMP/Finished Pharmaceuticals/Adulterated
Seaway Pharma Inc.
- 2025-12-02
Compounding Pharmacy/Adulterated Drug Products
PQ Pharmacy, LLC
See Also (8)
- CVM GFI #255 Elemental Impurities in Animal Drug Products Questions and Answers (Status: Final)
- CVM GFI #61 Special Considerations, Incentives, and Programs to Support the Approval of New Animal Drugs for Minor Uses and for Minor Species (Status: Final)
- CVM GFI #120 Veterinary Feed Directive Regulation Questions and Answers (Status: Final)
- Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications (Status: Final)
- CPG Sec. 460.100 Hospital Pharmacies - Status as Drug Manufacturer (Status: Final)
- CPG Sec. 430.200 Repacking of Drug Products - Testing/Examination under CGMPs (Status: Final)
- CPG Sec. 425.300 Computerized Drug Processing; Source Code for Process Control Application Programs (Status: Final)
- CPG Sec. 410.100 *Finished Dosage Form Drug Products in Bulk Containers - Applications of Current Good Manufacturing Practice Regulations* (Status: Final)