FDA Eases Sterility Requirements

The US Food and Drug Administration has relaxed some of the rules governing how companies must test the sterility of materials used to make biologic drugs.

By | May 16, 2012

WIKIMEDIA COMMONS, LASTORSET

Drug companies that manufacture biologics—drugs, vaccines, or diagnostics made using living organisms—will have less trouble testing and proving the sterility of their materials and products when new rules outlined by the US Food and Drug Administration go into effect next month.

The FDA’s detailed rules, which appeared in the Federal Register at the beginning of May, hinge upon state-of-the-art testing methods, which should make determining the sterility of biological products and the materials used to make them simpler. Specifically, the rules eliminate specified sterility test methods, culture media formulae, and culture media test requirements; eliminate the specified membrane filtration procedures required for certain products; eliminate specified sterility test requirements for most bulk material; modify the repeat sterility test requirements, so that repeat tests will occur only once for each product lot; and replace storage and maintenance requirements, testing sample sizes, and test interpretations with simplified guidelines.

In short, the FDA is reacting to the evolution of testing technology with rapid and advanced impurity detection capabilities to provide "manufacturers the flexibility to take advantage of methods as they become available, provided that these methods meet certain criteria," according to the Federal Register entry.

The rules go into effect on June 4.

Advertisement

Add a Comment

Avatar of: You

You

Processing...
Processing...

Sign In with your LabX Media Group Passport to leave a comment

Not a member? Register Now!

LabX Media Group Passport Logo

Comments

Avatar of: Astrid CS

Astrid CS

Posts: 1457

May 16, 2012

I suppose we are making things easier for China to kill us!

Popular Now

  1. Mapping the Human Connectome
    Daily News Mapping the Human Connectome

    A new map of human cortex combines data from multiple imaging modalities and comprises 180 distinct regions.

  2. Will Organs-in-a-Dish Ever Replace Animal Models?
  3. Your Office Has a Distinct Microbiome
  4. Neurons Compete to Form Memories
RayBiotech