تضمین کیفیت و کنترل میکروبیولوژیکی دارویی: راهنمای عملی برای تولید غیر استریل ۲۰۱۹
Pharmaceutical Microbiological Quality Assurance and Control: Practical Guide for Non-Sterile Manufacturing 2019

1. Cover

2. Table of Contents

3. Editors

4. List of Contributors

5. Preface

6. Foreword

7. Acknowledgments

1 Microbiological Control Strategy

2 Microbial Contamination Risk Assessment in Non‐sterile Drug Product Manufacturing and Risk Mitigation

3 Qualification of Microbiological Laboratory Personnel and Equipment

4 Introduction to Culture Media in Pharmaceutical Microbiology for Non‐sterile Products

5 Microbiological Examination of Non‐sterile Final Dosage Forms and Raw Material Including Acceptance Criteria and Testing Frequency

6 Microbial Requirements and Testing of Primary Packaging

7 Utilities Design and Testing

8 Microbiological Environmental Monitoring

9 Identification of Microorganisms

10 Calculating Alert Levels and Trending of Microbiological Data

11 Exclusion of Objectionable Microorganisms from Non‐sterile Pharmaceutical Drug Products

12 Data Integrity and Microbiological Excursion Handling

13 Rapid Microbiological Methods

14 Validation of a Rapid Microbiological Method for the Microbiological Examination of Non‐sterile and Nonfilterable Drug Products, APIs, and Excipients

15 An Ex‐Regulator's View of the Microbiology QA/QC Functions in the US Pharmaceutical Industries

16 Practical Guide for Microbiological QA/QC of Non‐sterile Pharmaceuticals Manufacturing for EU

17 Which Microbiological Tests Can Better Be Performed In‐house and What Can Be Easily Outsourced

25. Index

26. End User License Agreement