Terminally Sterilized Pharmaceutical Products—Parametric Release (New Usp<1222>, November 2019) And Its Relationship to The New British Terminal Sterilization Methodology (March 2019)
Parametric release is defined as the release of terminally sterilized batches or lots of sterile products based upon compliance with the defined critical parameters of sterilization without having to perform the testing requirements under USP<71> Sterility Tests.
Parametric release becomes possible when the mode of sterilization is 1) very well understood, 2) the physical parameters of processing are well defined, predictable, and measurable, 3) and the lethality of the cycle has been microbiologically validated through the use of appropriate biological indicators or, in the case of ionizing radiation, the appropriate microbiological and dosimetric tests.
The use of parametric release for sterilization processes requires prior FDA approval. It should be expected that the regulatory agencies evaluating submissions including the use of parametric product release would insist upon a well-supported scientific rationale for the sterilization process and well-documented validation data.
The agencies would need assurance that any marketed sample of the product will be sterile and, if tested after release, would pass the requirements for sterility as found in the General Chapter USP<71> Sterility Tests.
It is important to consider the limitations of the USP<71> in the evaluation of terminally sterilized products. The sterility test described in General Chapter USP<71> is limited in its sensitivity and is statistically ill-suited to the evaluation of terminally sterilized products given the exceedingly low probability of finding contaminated units.
Therefore, once a sterilization process is fully validated and operates consistently, a combination of physical sterilization data such as accumulated lethality or dosimetry in combination with other methods, such as load monitors (e.g., biological indicators, thermochemical indicators, or physicochemical integrators), can provide more accurate information than the sterility test regarding the release of terminally sterilized product to the marketplace.
There are four modes of sterilization that theoretically and practically qualify for parametric release: moist heat, dry heat, ethylene oxide, and ionizing radiation sterilization.
This General Information Chapter (USP<1222>) will first cover the general issues related to parametric release, regardless of the modes of sterilization, and then discuss some specific modes of sterilization. It will also include information on USP<55> Biological Indicators as well as the EU “Guideline on the Sterilization of Medicinal Products…” (March 2019). The webinar will discuss why it provides more accurate information than the sterility test regarding the release of terminally sterilized products to the marketplace.
Please plan to bring a team to this Webinar to examine how these issues and their solutions may assist you in more rapidly releasing sterile products from your facilities.
Learning Objectives:-
Who Will Benefit:-
Barry A. Friedman, Ph.D., is a Senior Consultant in the Biotechnology, Regulatory Compliance, Microbiology, and Aseptic Processing arena. From 2000 to 2007, Dr. Friedman was associated with Cambrex Bio Science Baltimore, a contract manufacturer of GMP bulk biopharmaceuticals located in Baltimore, MD. In that capacity as the Director of Quality Control, he managed a multi-shift Department of thirty-one individuals involved in Client management, the receipt and testing of raw materials, environmental monitoring and microbiology, analytical chemistry,y and QC compliance for the production of Phase 1, 2, 3 and commercial products manufactured from bacteria, yeast and mammalian cells. In this capacity, Dr. Friedman enjoyed many client and regulatory compliance interactions. Dr. Friedman has over 30 years of industrial managerial experience in various aspects of biopharmaceuticals and medical devices including regulatory compliance, expert witness assistance, quality control, sterility assurance, microbiological/analytical validations, and fermentation technology. In addition to the associations listed above, other associations have included Chesapeake Biological Laboratories, W.R. Grace, Sigma Chemical Co., Sherwood Medical, Becton Dickinson, American Cyanami,d, and Union Carbide. Dr. Friedman is a frequent seminar and webinar speaker and specializes in the areas of regulatory compliance, internal auditing, aseptic processing for sterile drug products, USP and Warning Letter “dissection”, multi-departmental interactions, validations and the requirements for the manufacture of Phase 1, 2 and 3 clinical trial materials. He has recently given presentations for the FDA, PDA, PTi, TungstenShield, Compliance Online, IPA (Canada), and Pharmig (UK). He maintains an active Blog (www.barryafriedmanphdllc.com) that contains over 200 Blogs that address various Warning Letters and FDA 483 issues. The Blog also contains over 1,500 “Search” terms to enable one to locate a particular regulatory action. He is a member of ASM and PDA. He served as a Captain in the Medical Service Corps, U.S. Army,y and is the past President and current of the Capital Area Chapter, PDA. He recently received the James Agalloco Award from PDA which is awarded to a PDA faculty member who exemplifies outstanding performance in education.
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