Books + eBook: Application of Microorganisms in Drug Discovery and Environment Microbes Compliant with GMP
Utilization and Management of Microorganisms by Development/Manufacturing Stages - Printable
【Book + eBook】 For details and applications for this product, please check our website. https://www.science-t.com/ebook/22196.html 【Comprehensive Guide to Microorganisms in Pharmaceuticals】 "Microorganisms that are Beneficial and Harmful" Unraveling the roles and issues of pharmaceuticals and microorganisms that are inextricably linked Natural product drug discovery methods and considerations for generic production, looking ahead to active pharmaceutical ingredient production Microbial management in laboratories/manufacturing sites compliant with PIC/S - Deviations/Alerts, Actions, Monitoring - ■ Considerations for natural product drug discovery aimed at new drug and generic development Are there really no useful microorganisms left that could become new drugs... What should be known at the development stage with an eye on the manufacturing line... The microorganisms involved in past pharmaceutical development and those currently being developed... ■ Considerations for microbial management in laboratories/manufacturing sites compliant with PIC/S What is microbial testing management and how to handle re-testing/validation... What are the environmental monitoring methods that comply with the three pharmacopoeias/GMP... What are the alert/action levels and deviation responses in microbial management...
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■Authors Daisuke Fukuda, Daiichi Sankyo RD Novare Co., Ltd. Shigeo Kawada, NPO Pharmaceutical and Food Quality Assurance Support Center Daikichiro Murakami, Taikisha Ltd. ■Table of Contents Part 1: Drug Production from Microorganisms, Natural Product Drug Discovery Introduction 1. Drug Discovery from Microorganisms: Current Status of Natural Product Drug Discovery 2. Practical Aspects of Natural Product Drug Discovery 3. New Microbial Resources for Natural Product Drug Discovery Others Conclusion: The Future of Natural Product Drug Discovery Part 2: Microbial Testing Management and Re-testing/Validation in Compliance with PIC/S GMP 1. A Comparative Study of the Three Regions Based on PIC/S GMP for Aseptic Pharmaceuticals 2. Implementation of Microbial Testing 3. Out of Specification (OOS) Results of Microbial Testing and Regulations for Re-testing Others Part 3: Environmental Monitoring and Deviation Management/Alert and Action Levels in the Pharmacopoeia and GMP of the Three Regions Introduction: Concept of Deviations in the Regulations of the Three Regions 1. Locations of Deviation Expressions in EU-GMP 2. Scope of Deviation Management 3. Importance of Deviation Management Others Summary: Conclusion from USP29 <1116>
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