Book: Manufacturing of Non-Sterile Pharmaceuticals, Quality Control / Required Levels of Microbial Control
Implementation of microbial limit testing methods based on the 3-Pole Guidelines (case studies for each dosage form) and rapid microbial testing methods.
There are few clear regulations regarding the manufacturing and quality control of non-sterile pharmaceuticals... To what extent is it necessary to respond? Approaching that gray area!! ✔ Frequency of monitoring, examples of deviation handling ✔ Risk-based approach to contamination control in the manufacturing of non-sterile pharmaceuticals ~ Management of environmental monitoring in non-sterile manufacturing areas (frequency, acceptance criteria) according to USP <1115> ✔ Handling of deviations ~ Guidance from the ECA Pharmaceutical Microbiology Working Group ✔ Microbial monitoring of pharmaceutical water - Standards and testing methods for microorganisms in pharmaceutical water ✔ Necessary levels of microbial control for non-sterile pharmaceuticals and considerations for validation and implementation of microbial limit testing methods ✔ Operational examples and case studies of microbial limit testing for non-sterile products (formulations, pharmaceutical raw materials) ~ Points to consider for each dosage form (powder, liquid, ointment, tablet, capsule, aerosol, transdermal patch) ✔ Implementation methods and application examples of rapid microbial testing methods in manufacturing environments (airborne bacteria) (pharmaceutical water) ✔ Development and reconstruction methods for foreign matter and insect management programs in non-sterile manufacturing areas, along with training examples.
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■Authors Kayo Sugaya, Tanabe Mitsubishi Pharma Corporation Shoichi Nakayama, Pharmaceutical and Food Quality Assurance Center (Non-Profit) Yosuke Oda, Pharmaceutical and Food Quality Assurance Support Center (Non-Profit) Daikichiro Murakami, Hiraara Engineering Service Co., Ltd. Kenichi Yamada, Food and Drug Safety Center (Public Interest Incorporated Foundation) Yasuto Ikematsu, Osaka University Mori Sakai, Earth Environmental Services Co., Ltd. ■Table of Contents Chapter 1: Measurement Methods and Setting of Reference Values for Environmental Monitoring in the Manufacture and Quality Control of Non-Sterile Pharmaceuticals, and Deviation Management Chapter 2: Environmental Management in the Manufacturing Control of Non-Sterile Pharmaceuticals and Key Validation Points Required by PIC/S GMP for Non-Sterile Pharmaceuticals Chapter 3: Microbial Monitoring of Pharmaceutical Water for Non-Sterile Pharmaceuticals Chapter 4: Air Conditioning Management Standards in the Manufacturing Environment of Non-Sterile Pharmaceuticals Chapter 5: Required Levels of Microbial Control for Non-Sterile Pharmaceuticals and Considerations for Validation and Implementation of Microbiological Testing Methods Chapter 6: Microbial Limit Test Methods Based on the Three-Region Pharmacopoeia and Implementation Examples by Dosage Form Chapter 7: Implementation and Considerations for Rapid Microbial Testing Methods Chapter 8: Management of Foreign Matter and Insects in Manufacturing Areas of Non-Sterile Preparations and Levels of Prevention of Foreign Matter Contamination
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