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# FDA On Parametric Release for Sterile Drugs
- URL: https://www.fdaweb.com/fda-on-parametric-release-for-sterile-drugs/
- Published: 2023-08-11T12:00:00.000Z
- Updated: 2026-09-14T18:49:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155083

FDA has updated its [Web page](https://www.fda.gov/drugs/guidances-drugs/questions-and-answers-current-good-manufacturing-practice-regulations-production-and-process?ref=fdaweb.com) on “Questions and Answers on Current Good Manufacturing Practice Regulations — Production and Process Controls” to address whether parametric release is an appropriate control strategy for sterile drug products that are not terminally sterilized. According to the new post, parametric release is only appropriate for terminally sterilized drug products. “Although both terminally sterilized and aseptically processed drug product batches are required to meet the sterility test requirement (see 21 CFR 211.167(a)) before release to the market, there are inherent differences between the production of sterile drug products using terminal sterilization and aseptic processing,” it says.

The agency’s clarification notes that terminally sterilized products are rendered sterile in their final, sealed units by sterilizers. “Discrete physical parameters (e.g., temperature, pressure, and time) are continuously measured and controlled with robust precision and accuracy during processing,” it says. “Additionally, parametric release incorporates a sterilization load monitor that is integral to satisfying the requirement for a sterility test (see § 211.167(a)) by confirming that the load has been exposed to the prescribed physical conditions. This allows manufacturers to couple adherence to sterilization cycle parameters with a load monitor to determine thermal lethality, thereby directly confirming sterility and substituting for the sterility test.”

Regarding aseptic processes, FDA says these do not subject the final sealed drug product to a sterilization cycle, and monitoring sterility hazards for drugs manufactured throughout aseptic manufacturing operations relies on indirect measurements. “The sterility test is therefore an essential element to monitor the state of control of an aseptic operation, and it is the last step in a series of fundamental, required controls that collectively contribute to the minimum assurance that a given manufacturing operation produced a drug that meets its sterility claim,” it says.

FDA also notes that all quality control tests, including sterility tests, have limitations. “Although the sterility test may not exhaustively assess batch sterility, the sterility test is, nonetheless, a critical component of a comprehensive control strategy that is designed to prevent microbiological contamination of drug products purporting to be sterile (21 CFR 211.113(b)),” it says. It adds sterility testing innovations (e.g., rapid microbiological methods, genotyping) integrated into manufacturing operations may further improve “prompt operational feedback, which can result in significant batch release efficiencies while ensuring equivalent or better ability to detect nonsterility compared with the compendial method. FDA encourages the use of beneficial testing innovations in conjunction with advanced manufacturing technologies (e.g., robotic isolators) to enhance process design and improve both microbial detection and identification.”