Microbiology Testing: USP Requirements for …

2017 Quality Compounding SummitMicrobiology Testing: USP Requirements for Sterile and Nonsterile PreparationsThomas C. Kupiec, PhDCEO / 2017 Quality Compounding SummitDisclosuresThomas Kupiec declare(s) no conflicts of interest, real or apparent, and no financial interests in any company, product, or service mentioned in this program, including grants, employment, gifts, stock holdings, and honoraria. The American College of Apothecaries is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. 2017 Quality Compounding SummitAgenda Review of USP Microbiology General Chapters Microbiological Tests Biological Tests and Assays Informational Chapters USP Nonsterile Drug Product testing Requirements Environmental Monitoring Investigations and Microbial Identification 2017 Quality Compounding SummitLearning ObjectivesAt the conclusion of this program, the participatingpharmacist or technician will be able testing Requirements based on USP Microbiology test general microbiological tests used in managing the production of nonsterile drug sterility test results and assess sterility test areas of pharmacy operations that require environmental monitoring 2017 Quality Compounding SummitEXPLAIN testing Requirements BASED ON USP Microbiology TEST GENERAL CHAPTERS 2017 Quality Compounding SummitUnited States Pharmacopeia Scientific nonprofit organization that sets standards for the qua

Applies to substances, preparations, or articles which, according to the Pharmacopeia, are required to be sterile . • Pharmacopeial procedures

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