CVM GFI #135 Validation of Analytical Procedures for Type C Medicated Feeds | Guideline Explorer

Description

Section 512(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 360b) establishes the requirements for new animal drug approval. 21 CFR 514.1 specifies the information required to be submitted as part of the application and the proper form for the submission. Section 514.1(b)(5)(vii) requires an applicant to describe analytical procedures that should be capable of determining the active component(s) within a reasonable degree of accuracy and of assuring the identity of such components. Section 514.1(b)(5)(vii)(a) states that a description of practicable methods of analysis of adequate sensitivity to determine the amount of the new animal drug in the final dosage form should be included.

Scope & Applicability

Product Classes

1

Type C Medicated Feeds

Complete feeds that can be fed as is.

Stakeholders

2

Applicant

Entity submitting development data and knowledge; Entity performing the work process for change

Sponsor

Entity responsible for submitting applications under section 524B

Regulatory Context

Attributes

3

Relative standard deviation

A statistical parameter recommended for reporting precision.

Signal-to-Noise Ratio

Used for estimating detection and quantitation limits

Correlation coefficient

Recommended to be at least 0.995 for linearity evaluation.

Identified Hazards

Hazards

1

Sample matrix effects

Chromatographic profile may indicate co-eluting peaks or sample matrix effects.

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 →