Sterile Manufacturing Draft Guidance Provides Application Information

Rockville, MD (Aug 14)-The US Food and Drug Administration issued a new draft guidance for public comment on sterile manufacturing. Titled Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes, the guidance provides recommendations on what to include in a new drug application (NDA), abbreviated new drug application (ANDA), new animal drug application (NADA), abbreviated new animal drug application (ANADA), biologics license application (BLA), or supplement or other postmarketing report regarding parametric release for sterile products terminally sterilized by moist heat.

Currently, FDA requires that sterile products meet certain sterility requirements before release to the market. According to the draft guidance, the requirements for batch release are most often fulfilled with a sterility test of finished units drawn from the batch. Parametric release is defined as a sterility assurance release program where demonstrated control of the sterilization process enables a company to use defined critical process controls, in lieu of the sterility test, to fulfill the intent of 21 CFR 211.165(a), and 211.167(a).

With this strategy, market release of terminally sterilized products can be based on meeting the defined sterilization parameters rather than  performing an approved sterility test. “Meeting the requirements of the parametric release process,” according to the draft guidance, “can provide greater assurance that a batch meets the sterility requirement than can be achieved with a sterility test of finished units drawn from the batch.”

The guidance may apply to products sterilized by other terminal sterilization processes such as radiation sterilization, which may be suitable for parametric release.

Comments on the draft guidance are due Oct. 6. Read the full draft guidance.