FDA to lighten sterility test requirements

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Comments on a proposed rule to relax sterility test requirements for biological products must be submitted to the FDA by Sept. 19. Published June 21 in the Federal Register, the proposal is aimed at increasing flexibility for manufacturers by encouraging state-of-the-art methods, and includes elimination of specified sterility test requirements.

Sterility currently must be performed on bulk and final container material for each lot of biological products prior to release, with limited exceptions, according to the agency. The proposed rule suggests eliminating sterility test requirements for bulk materials, because in most cases the most appropriate test material is the final container. Additonally, the rule would allow manufacturers to apply for alternative methods authorizations.

“If this proposed rule is finalized, a manufacturer who desires to utilize an alternative sterility test method other than the one approved in its biologics license application (BLA) must submit a BLA supplement in accordance with [the rule],” the article stated.

The FDA noted the following significant changes:

  • Elimination of specified sterility test methods, culture media formulae and culture media test requirements.
  • Elimination of specified membrane filtration procedure requirements for certain products.
  • Elimination of specified sterility test requirements for most bulk material.
  • Modification of the repeat sterility test requirements, so that repeat tests would only occur once for each lot. These tests would be limited to situations when the quality control unit conclusively determines, after conducting an investigation upon detection of viable microbial contamination during the initial test of the lot, that the contamination is the result of laboratory error or faulty materials used in conducting the sterility test.
  • Replacement of the storage and maintenance requirements for cultures of test organisms used to determine the “growth-promoting qualities” of culture media with: Validation requirements specifying that any sterility test used is able to consistently detect the presence of viable contaminating microorganisms and verification of “growth-promoting properties” or microorganism-detection capabilities of test and test components.
  • Replacement of the sample size or amount requirement with a requirement that the sample be appropriate to the material being tested.
  • Replacement of the "Interpretation of test results" paragraph under 610.12(c) with a requirement that manufacturers establish, implement, and follow written procedures for sterility testing that describe, at a minimum, the test method used, the method of sampling and the written specifications for acceptance or rejection of each lot.
  • Simplification of the "Exceptions" paragraph under 610.12(c).

The FDA anticipates the rule will affect few manufacturers. It can be found here.