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 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 product to the marketplace.
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 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> Sterility Tests 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 could qualify for parametric release: moist heat, dry heat, ethylene oxide, and ionizing radiation sterilization.
Areas Covered in the Webinar:
Barry A. FriedmanConsultant in Biotechnology, Regulatory Compliance and Aseptic Processing Arena
Barry A. Friedman, Ph.D., is a Senior Consultant in the Biotechnology, Regulatory Compliance, Microbiology and Aseptic Processing arena. Dr. Friedman has over 30 years of industrial managerial experience in various aspects of biopharmaceuticals and medical devices to include regulatory compliance, expert witness assistance, quality control, sterility assurance, microbiological/analytical validations and fermentation technology.
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, 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 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.
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 Cyanamid 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 (PharmaWebinars), IPA (Canada), Executive Conference Corp, Compliance On-Line and Pharmig (UK).
Dr. Friedman maintains an active Blog (www.barryafriedmanphdllc.com) that contains over 200 Blogs that address various Warning Letter and FDA 483 issues as well as over 1,500 “Search” terms to assist with finding the appropriate Warning Letter and FDA 483. He is a member of ASM, PDA and RAPs. He served as a Captain in the Medical Service Corps, U.S. Army and is the past President and current Treasurer 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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