Description
In the Federal Register of July 8, 1997, the Food and Drug Administration announced the availability of Revised Form FDA 356h “Application to Market a New Drug, Biologic, or an Antibiotic for Human Use.” This document provides guidance on the content and format of the Chemistry, Manufacturing, and Controls (CMC) section of a Biologics License Application for an Allergenic Extract or Allergen Patch Test.
Scope & Applicability
Product Classes
4Specific product class mentioned in guidance references
Guidance on the content and format of CMC information for an Allergen Patch Test.; biological drug substance and product definitions; Guidance for Chemistry, Manufacturing and Controls information; Scope of the license application guidance
License applications for allergenic extracts or allergen patch tests
Licensed extracts for subcutaneous immunotherapy; licensed products for subcutaneous immunotherapy
Stakeholders
1parties responsible for manufacture or testing; Manufacturers responsible for portions of manufacture
Regulatory Context
Attributes
3measured during operations to prevent contamination; Floor diagram of facility areas should include air quality classification
Measured between adjacent manufacturing areas
established based on data from stability studies
Identified Hazards
Hazards
2Risk associated with construction, traffic flow, and shared equipment.; Risk from raw food to RTE food or from insanitary objects; Personnel handling RTE foods touch contaminated surfaces
Causative agent requiring inactivation controls
Related CFR Sections (2)
- 21CFR680.1§ 680.1 Allergenic Products.
(a) Definition. Allergenic Products are products that are administered to man for the diagnosis, prevention or treatment of allergies.Read full regulation →
- 21CFR680.3§ 680.3 Tests.
(a) Identity. When a specific identity test meeting the provisions of § 610.14 of this chapter cannot be performed, the manufacture of each lot shall be separated from the manufacture of other products in a manner that will preclude adulteration, and records made in the course of manufacture shall bRead full regulation →
See Also (8)
- Guidance for Industry: Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to CFSAN (Status: Final)
- Guidance for Industry: Questions and Answers About the Food Additive or Color Additive Petition Process (Status: Final)
- Guidance for Industry for the Submission of Chemistry, Manufacturing, and Controls Information for a Therapeutic Recombinant DNA-Derived Product or a Monoclonal Antibody Product for In Vivo Use (Status: Final)
- Environmental Assessment of Human Drug and Biologics Applications: Guidance for Industry (Status: Final)
- Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Vaccine or Related Product: Guidance for Industry (Status: Final)
- For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Plasma-Derived Biological Products, Animal Plasma or Serum-Derived Products: Guidance for Industry: (Status: Final)
- Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Biological In Vitro Diagnostic Product: Guidance for Industry (Status: Final)
- CVM GFI #187A Heritable Intentional Genomic Alterations in Animals: Risk-Based Approach (Status: Final)