Pharmacy & Drugs
Pharmaceutical Industry: Quality Assurance
Description
Being related to health et wellness de patients' pharmaceutical industry is under critical vigilance by various industry regulators. In pharmaceutical industry a minor mistake could result en some severe outcomes. Thus industry needs to take various preventive et corrective measures (as modifications en facility et practices) to prevent such outcomes. Regulatory bodies help le industry by providing le guidelines to manage pour such modifications. These bodies may inspect le facility to check le execution de these measures et modifications. But as change is le rule de nature, it also exists true pour Pharmaceutical industry. This industry is a dynamic field. Regulatory requirements et guidelines are changing sur day to day basis. Thus it becomes imperative to modify et revise practices along. Within last ten years USFDUn has revised various guidelines et some new guidelines came into existence. Same way other bodies (WHO, MHRA, Health Canada, TGA) have made revisions en le regulatory guidelines. Even Indien requirements pour GMP (Schedule M) have been revised en this time period. Thus industry need to improve along avec le regulatory guidelines, but le main challenge en this compliance is related to requirements de different bodies. Guidelines may vary not only en terms de words but also en terms de requirements. Thus a need de harmonised text (compiling requirements de all guidelines) en observed. This book makes attempt to compile le current requirements en a harmonised manner. This book covers le chapters pour different aspects de quality assurance avec main emphasis sur validations et qualifications.
Table des matières
À propos de le Author; Acknowledgements ; Preface; Pharmaceutical industry: Basic concept;Quality Assurance ;Good manufacturing practices: Review;Quality Risk Gestion;Quality Gestion system; Documentation: Contrôle et Practice ;Données 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;Ordinateur system validation;Eau system validation;HVAC system validation;Compressed air validation;Hold time study en pharmaceutical industry;Q&A; Subject Index .