FDA proposes Changes in Sterility Testing of Biological Products

After first activities on a European level to revise the chapter 5.1.6. "Modern Microbiological Methods", the latest edition of the Federal Register (Vol. 76, No. 119 / Tuesday, June 21, 2011) now shows a very important announcement about the sterility test of biological products. If the proposal will pass it will mark a step forward towards the adoption of rapid and alternative microbiological methods.

The proposed rule is intended to provide manufacturers of biological products with greater flexibility and to encourage the use of the most appropriate and state-of-the-art test methods for assuring the safety of biological products.

Several changes are proposed:

  • Eliminations of specified sterility test methods, culture media formulae (or formulations), and culture media test requirements
  • Elimination of specified membrane filtration procedure requirement 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 occur only once for each lot
  • Replacement of the storage and maintenance requirements for cultures of test organisms used to determine the ''growth-promoting qualities'' of culture media with: (1) Validation requirements specifying that any sterility test used is able to consistently detect the presence of viable contaminating microorganisms and (2) verification of ''growth promoting properties'' 6 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 with regard 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; and
  • Simplification of the Exceptions paragraph under § 610.12(c).

Please also see the Federal Register for the complete document.

A unique possibility to discuss proposed changes with representatives of the European and US authorities provides the "Rapid Microbiological Methods Conference" in Berlin, Germany, from 7-8 December 2011.

Axel H. Schroeder
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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