Ebook: Pharmaceutical Microbiological Quality Assurance and Control: Practical Guide for Non-Sterile Manufacturing

Cover; Title Page; Copyright Page; Contents; Editors; List of Contributors; Preface; Foreword; Acknowledgments; 1 Microbiological Control Strategy; 1.1 Introduction; 1.2 Overview of a Microbial Control Strategy Program; 1.3 Main Factors to Be Controlled; 1.3.1 Controlled Facilities; 1.3.2 Controlled Procedures; 1.3.3 Controlled Product Ingredients; 1.3.4 Controlled Utilities; 1.3.5 Controlled Equipment; 1.3.6 Controlled Formulation; 1.4 Conclusion; Bibliography; 2 Microbial Contamination Risk Assessment in Non-sterile Drug Product Manufacturing and Risk Mitigation; 2.1 Introduction