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) and Establishment Description sections of a License Application for a vaccine or related product. Reagents for in vitro diagnostic use are outside the scope of this document
Scope & Applicability
Product Classes
9Preventative or therapeutic vaccines for infectious diseases.
Guidance for Industry for the Evaluation of Combination Vaccines
Includes synthetic peptides and conjugates
Microbial cells used as vaccine drug substance
Derived from microbial cells or modified cell substrates
Vaccine related products include in vivo diagnostic antigens.
RTRT and CTD sections apply to drug substances
RTRT and CTD sections apply to drug products
each active substance should be described
Stakeholders
3Entity responsible for submitting NDINs
personnel who must receive training on Listeria control
responsible for manufacture or testing
Regulatory Context
Attributes
5measured during operations to prevent contamination; Floor diagram of facility areas should include air quality classification
established based on data from stability studies
Level and type of micro-organisms present in materials
property of the MCB after multiple passages
Health status of animals used for propagation
Identified Hazards
Hazards
5Addressed in the contamination/cross contamination issues section.
microbiological contamination risk in bulk solution
Safety concern regarding viral contamination
Potential that transformation was caused by an adventitious agent; A microorganism inadvertently introduced into the production of a biological product.; Detection of contaminants in cell substrates and vaccine components
Risk 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
Related CFR Sections (1)
- 21CFR601.2§ 601.2 Applications for biologics licenses; procedures for filing.
(a) General. To obtain a biologics license under section 351 of the Public Health Service Act for any biological product, the manufacturer shall submit an application to the Director, Center for Biologics Evaluation and Research or the Director, Center for Drug Evaluation and Research (see mailing aRead full regulation →
See Also (8)
- Advanced Manufacturing Technologies Designation Program (Status: Final)
- Environmental Assessment of Human Drug and Biologics Applications: Guidance for Industry (Status: Final)
- Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format - Biologics Marketing Applications: Guidance for Industry (Status: Final)
- Submission of Abbreviated Reports and Synopses in Support of Marketing Applications. (Status: Final)
- Use of Sterile Connecting Devices in Blood Bank Practices: Guidance for Industry (Status: Final)
- Submitting Marketing Applications According to the ICH/CTD Format: General Considerations (Status: Draft)
- Pharmacogenomic Data Submissions; Examples of Voluntary Submissions or Submissions Required Under 21 CFR 312, 314, or 601 (Status: Final)
- Pharmacogenomic Data Submissions: Guidance for Industry (Status: Final)