Description
The quality of drug substances and medicinal products is determined by their design, development, in-process controls, GMP controls, and process validation, and by specifications applied to them throughout development and manufacture. This guidance addresses specifications, i.e., those tests, procedures, and acceptance criteria which play a major role in assuring the quality of the new veterinary drug substance and medicinal product at release and during shelf life. Specifications are an important component of quality assurance, but are not its only component. All of the considerations listed above are important to ensure consistent production of drug substances and medicinal products of high quality.
Scope & Applicability
Product Classes
10Subject of stability testing guidance
Is the medicinal product a dry dosage form (e.g. solid oral or dry powder)?
MICROBIOLOGICAL ATTRIBUTES OF NON-STERILE MEDICINAL PRODUCTS
specific test conditions and acceptance criteria for immediate release
pharmaceutical product type containing a new or existing drug substance
products formulated to make drug available over an extended period; appropriate acceptance ranges for extended release
packaged in pre-filled syringes or autoinjector cartridges
tests may be applicable to parenteral medicinal products
specific tests will normally be applicable to oral liquids
Specifications for New Veterinary Drug Substances and New Medicinal Products
Stakeholders
2Entity responsible for submitting NDINs
Group committed to achieving harmonization of procedures
Regulatory Context
Attributes
10Physical property of drug substance affecting manufacturability
Intrinsic characteristic affecting the growth of L. monocytogenes; intrinsic characteristic used as a process control; parameter to monitor for control; Process control parameters such as pH; Used to define listeristatic formulations
Property used in the decision tree for in-vitro testing
Factor in determining particle size acceptance criteria.
Measured using NIR results
Biological property that may be altered by manufacturing changes; safety narrative should address bioavailability of the ingredients
criteria for parenteral products requiring reconstitution
appropriate for injectable suspensions which settle on storage
Physical attribute affecting mucosal integrity
Critical attribute impacting bioequivalence of locally acting TAMAs.
Identified Hazards
Hazards
1risk in multidose drug products
Related CFR Sections (3)
- 21CFR211.165§ 211.165 Testing and release for distribution.
(a) For each batch of drug product, there shall be appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release. Where sterility and/or pyrogen testing are conducted on sRead full regulation →
- 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 →
Related Warning Letters (10)
- 2025-07-08
CGMP/Finished Pharmaceuticals/Adulterated
Libby Laboratories, Inc.
- 2025-02-18
CGMP/Finished Pharmaceutical/Adulterated
Marshalls Traditional Healthcare CC
- 2024-09-24
CGMP/Finished Pharmaceuticals/Adulterated
Wittman Pharma, Inc.
- 2024-06-18
CGMP/Finished Pharmaceuticals/Unapproved New Drug/Adulterated
Aqualex Co., Ltd.
- 2023-08-29
CGMP/Finished Pharmaceuticals/Adulterated
Cosmobeauti Laboratories & Manufacturing Inc.
- 2023-08-01
CGMP/Finished Pharmaceuticals/Adulterated
Jamol Laboratories, Inc.
- 2023-05-09
CGMP/Finished Pharmaceuticals/Adulterated
Premier Nutra Pharma Inc.
- 2022-11-01
Compounding Pharmacy/Adulterated Drug Products
Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center, LLC
- 2022-08-16
CGMP/Finished Pharmaceuticals/Adulterated
Verde Cosmetic Labs LLC
- 2021-04-13
Drug/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Maison Terre, LLC
See Also (8)
- BLA for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System: Guidance for Industry (Status: Final)
- Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act Guidance for Industry: Draft Guidance for Industry (Status: Draft)
- Microbiological Quality Considerations in Non-Sterile Drug Manufacturing: Draft Guidance for Industry (Status: Draft)
- 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 #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)