The US Food and Drug Administration (US FDA) has issued a final rule on sterility testing on May 3, 2012, that amends the requirements for most licensed biological products and aims to provide manufacturers with the flexibility, as appropriate, to keep pace with technological and scientific advances. Indian biotechnology companies along with others globally will have to implement the changes as the rule takes effect June 4, 2012.
The rule is in response to President Obama’s Executive Order 13563 which called for improving regulation and regulatory review.
Specifically, the rule revises sterility requirements under Title 21 of the Code of Federal Regulations (CFR), sub chapter F, parts 600 through 680. It eliminates specified sterility test methods, culture media formulae or formulation, and culture media test requirements. It also does away with specified membrane filtration procedure requirements for certain products. There is no need for specified sterility test requirements for most bulk material. It modifies the repeat sterility test requirements, so that repeat tests will occur only once for each lot.
It also replaces 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 micro-organisms, and with verification of ‘growth-promoting properties’ or micro-organism-detection capabilities of test and test components.
In addition, it also replaces the sample size or amount requirement with a requirement that the sample be appropriate to the material being tested. It substitutes the interpretation of test results section 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.
It identifies the Director of Centre for Drug Evaluation and Research (CDER) as one of the two Centre directors authorized to grant an exemption under the exception provision at 610.12(h)(2). In the proposed rule, the Centre for Devices and Radiological Health was erroneously identified in this exception, instead of the CDER.
It revises the definition of the term “sterility” under 600.3(q). It eliminates certain exceptions for allergenic products related to sterility testing under 680.3(c). The proposed rule received several comments from industry and the final rule includes the agency’s response to those recommendations.
Overall, FDA recognizes the role innovation plays in bringing safe and effective products to market in a timely and cost-efficient manner. The agency’s efforts to review and update biologics regulations, to keep pace with technological developments helps to boost regulatory science, stated the guidance.