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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.

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

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Transcription of Microbiology Testing: USP Requirements for …

1 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.

2 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

3 That sets standards for the quality, purity, identity, and strength of medicines USP s drug standards are enforceable in the United States by the Food and Drug Administration The Federal Food, Drug, and Cosmetics Act designates the USP NF as the official compendia for drugs marketed in the United States. 2017 Quality Compounding SummitUnited States PharmacopeiaMonographs and General Chapters: A monograph consists of a series of tests, procedures for the tests, and acceptance criteria. General chapters less than 1000 are enforceable.

4 General information chapters greater than 1000 are not enforceable. 2017 Quality Compounding SummitUSP General Chapters for Sterile and Nonsterile Products Microbiological testing RequirementsGeneral Tests and Assays Microbiological TestsChapterAntimicrobial Effectiveness testing <51>Biological Indicators-Resistance Performance Tests<55>Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests<61>Microbiological Examination of Nonsterile Products: Tests for Specified Organisms<62>Sterility Tests<71>General Tests and Assays Biological Tests and AssaysChapterBacterial Endotoxins Test<85> 2017 Quality Compounding SummitGeneral InformationChapterMicrobiological Examination of Nonsterile Products.

5 Acceptance Criteria<1111>Microbial Characterization, Identification, and Strain Typing<1113>Bioburden Control of Nonsterile Drug Substances and Products<1115>Microbiological Control and Monitoring of Aseptic Processing Environments<1116>Microbiological Best Laboratory Practices<1117>Sterilization and SterilityAssurance of Compendial Articles<1211>Validation of Microbial Recovery from Pharmacopeial Articles<1227>Monitoring of Bioburden< >USP General Chapters for Sterile and Nonsterile Products Microbiological testing Requirements 2017 Quality Compounding SummitUSP <51>

6 Antimicrobial Effectiveness testing Demonstrates preservative effectiveness for all injections, topicals, oral products and antacids packaged in multiple-dose containers. Challenge organisms are generally based on likely contaminantsto a drug product. The sample scheme and acceptance criteria are based on its physical attributes, formulation, and intended use. 2017 Quality Compounding SummitUSP <51> Antimicrobial Effectiveness testing The procedures and acceptance criteria for effectiveness apply to a product in the original, sealed container in which it was distributed.

7 The ability of the procedure to detect challenge microorganisms in the presence of a suitably neutralized product to be tested must be established. (method suitability) The growth-promoting capabilities of media used in this procedure must be established. (growth promotion) 2017 Quality Compounding SummitUSP <51> Antimicrobial Effectiveness testing The sample is divided into 5 parts and each is individually inoculated with a challenge microorganism. This represents inadvertent introduction of organismsduring, or subsequent to, the manufacturing process, as well as introduction from repeatedly withdrawing individual doses from a multiple-dose container.

8 The inoculated product is tested throughout a 28 day incubation period where the population s log reduction is calculated. 2017 Quality Compounding SummitFor Category 1 Products - Parenterals, Nasal, and OpthalmicBacteriaNLT log reduction from the initial calculated count at 7 days, NLT log reduction from the initial count at 14 days, and no increase from the 14 days' count at 28 daysYeast and moldsNo increase from the initial calculated count at 7, 14, and 28 daysFor Category 2 Products - TopicalsBacteriaNLT log reduction from the initial count at 14 days.

9 And no increase from the 14 days' count at 28 daysYeast and moldsNo increase from the initial calculated count at 14 and 28 daysFor Category 3 Products - Oral ProductsBacteriaNLT log reduction from the initial count at 14 days, and no increase from the 14 days' count at 28 daysYeast and moldsNo increase from the initial calculated count at 14 and 28 daysFor Category 4 Products - AntacidsBacteria, yeast, and moldsNo increase from the initial calculated count at 14 and 28 daysUSP <51> Antimicrobial Effectiveness TestingTable 1.

10 Compendial Product Categories 2017 Quality Compounding Summit 2017 Quality Compounding SummitUSP 55 Biological Indicators-Resistance Performance Tests Provides confirmation of the spore count on or in a biological indicator. Biological indicators are spore containing strips or ampules that are used during development, validation, and control of sterilization processes. Viable spore count test is performed by subjecting the microorganisms contained in the biological indicator to conditions that encourage their growth, followed by subsequently incubating and counting the recovered colonies.


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