Drug Regulators, FDA, Publish Guidance on Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes.
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This guidance provides recommendations to applicants on information to include in support of parametric release for sterile products terminally sterilized by moist heat when submitting 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.
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).5 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.
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, we recommend the applicant discuss with the review division whether applying the guidance would be appropriate.
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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
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Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.
“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”
