Currently, FDA requires that sterile products meet certain sterility requirements before release to the market. In many cases, the requirements for batch release are fulfilled by conducting a sterility test on 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 firm 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). Under this strategy, market release of terminally sterilized products can be based upon meeting the defined sterilization parameters and not on performing an approved sterility test. Meeting the requirements of the parametric release process 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.

This guidance does not provide information on procedures, studies, or data concerning efficacy and qualification/validation of moist heat sterilization processes. This guidance also does not provide information on sterility assurance validation programs. However, you may find information relating to such topics in the Agency’s guidance for industry on Submission of Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products. Current Good Manufacturing Practices (CGMP) requirements for process validation are found at 21 CFR 211.100 and, for sterile products in particular, at 21 CFR 211.113(b). Adherence to CGMPs is required for all marketed products.

Outcome:

This guidance does not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

The principles in the guidance may also be applicable to products sterilized by other terminal sterilization processes, such as radiation sterilization, which may be suitable for parametric release. For these types of applications, FDA recommends the applicant discuss with the review division whether applying the guidance would be appropriate.

If you work within the topic sterilization, check the guidance and see, if there are any processes in your environment to approve.

Source:

FDA/ Guidance for Industry