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.