Pharmacy & Drugs
Pharmaceutical Industry: Quality Assurance
Description
Being related to health and wellness of patients' pharmaceutical industry is under critical vigilance by various industry regulators. In pharmaceutical industry a minor mistake could result in some severe outcomes. Thus industry needs to take various preventive and corrective measures (as modifications in facility and practices) to prevent such outcomes. Regulatory bodies help the industry by providing the guidelines to manage for such modifications. These bodies may inspect the facility to check the execution of these measures and modifications. But as change is the rule of nature, it also exists true for Pharmaceutical industry. This industry is a dynamic field. Regulatory requirements and guidelines are changing on day to day basis. Thus it becomes imperative to modify and revise practices along. Within last ten years USFDA has revised various guidelines and some new guidelines came into existence. Same way other bodies (WHO, MHRA, Health Canada, TGA) have made revisions in the regulatory guidelines. Even Indian requirements for GMP (Schedule M) have been revised in this time period. Thus industry need to improve along with the regulatory guidelines, but the main challenge in this compliance is related to requirements of different bodies. Guidelines may vary not only in terms of words but also in terms of requirements. Thus a need of harmonised text (compiling requirements of all guidelines) in observed. This book makes attempt to compile the current requirements in a harmonised manner. This book covers the chapters for different aspects of quality assurance with main emphasis on validations and qualifications.
Table of Contents
About the Author; Acknowledgements ; Preface; Pharmaceutical industry: Basic concept;Quality Assurance ;Good manufacturing practices: Review;Quality Risk Management;Quality Management system; Documentation: Control and Practice ;Data integrity ;Validation: Basic preview;Validation master plan;Equipment qualification;Non sterile process validation;Sterile Process validation;Media fill (Sterile simulation) study ;Cleaning validation;Analytical method validation;Computer system validation;Water system validation;HVAC system validation;Compressed air validation;Hold time study in pharmaceutical industry;Q&A; Subject Index .