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FDA Final Rule the Sterility Test for Biological Products

Monday the 21st May 2012

The US FDA has adopted significant changes to the sterility test for biological products that marks a major step forward towards the adoption of rapid and alternative microbiological methods. The FDA’s reason for this change was to provide manufacturers of biological products greater flexibility and to encourage use of the most appropriate and state-of-the-art test methods for assuring the safety of biological products. The final rule was adopted on 3 May 2012 and is effective from 4th of June 2012, a copy is attached.

On issuing the final rule the FDA stated that:

“The FDA recognizes the role innovation plays in bringing safe and effective products to market in a timely and cost-efficient manner. This action reflects the agency’s efforts to review and, as necessary, update biologics regulations, to keep pace with technological developments and to boost regulatory science.

The amendments to the sterility testing rule will provide manufacturers of biological products the flexibility, as appropriate, to keep pace with technological and scientific advances.”

The main changes are:

*Elimination 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’’ 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© 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©

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