Hardcover. Zustand: New. Contents: Preface. 1. Pharmaceutical industry: Basic concept. 2. Quality Assurance. 3. Good manufacturing practices: review. 4. Quality Risk Management. 5. Quality Management system. 6. Documentation: Control and Practice. 7. Data integrity. 8. Validation: Basic preview. 9. Validation master plan. 10. Equipment qualification. 11. Non sterile process validation. 12. Sterile Process validation. 13. Media fill (Sterile simulation) study. 14. Cleaning validation. 15. Analytical method validation. 16. Computer system validation. 17. Water system validation. 18. HVAC system validation. 19. Compressed air validation. 20. Hold time study in pharmaceutical industry. Q&A. Subject Index. 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 harmonized text (compiling requirements of all guidelines) in observed. This book makes attempt to compile the current requirements in a harmonized manner. This book covers the chapters for different aspects of quality assurance with main emphasis on validations and qualifications.
Anbieter: Ria Christie Collections, Uxbridge, Vereinigtes Königreich
EUR 34,97
Anzahl: Mehr als 20 verfügbar
In den WarenkorbZustand: New. In.
Anbieter: Ria Christie Collections, Uxbridge, Vereinigtes Königreich
EUR 26,71
Anzahl: Mehr als 20 verfügbar
In den WarenkorbZustand: New. In.
Anbieter: Ria Christie Collections, Uxbridge, Vereinigtes Königreich
EUR 29,87
Anzahl: Mehr als 20 verfügbar
In den WarenkorbZustand: New. In.
Anbieter: Revaluation Books, Exeter, Vereinigtes Königreich
EUR 35,70
Anzahl: 2 verfügbar
In den WarenkorbPaperback. Zustand: Brand New. 310 pages. 7.99x4.96x0.75 inches. In Stock.
Anbieter: PBShop.store UK, Fairford, GLOS, Vereinigtes Königreich
EUR 178,47
Anzahl: 1 verfügbar
In den WarenkorbHRD. Zustand: New. New Book. Shipped from UK. Established seller since 2000.
Anbieter: PBShop.store US, Wood Dale, IL, USA
HRD. Zustand: New. New Book. Shipped from UK. Established seller since 2000.
Anbieter: Revaluation Books, Exeter, Vereinigtes Königreich
EUR 41,51
Anzahl: 2 verfügbar
In den WarenkorbPaperback. Zustand: Brand New. 400 pages. Hindu language. 5.00x0.89x8.00 inches. In Stock.
Sprache: Hindi
Verlag: Repro India Limited Aug 2021, 2021
ISBN 10: 168523304X ISBN 13: 9781685233044
Anbieter: AHA-BUCH GmbH, Einbeck, Deutschland
Taschenbuch. Zustand: Neu. Neuware - In the poems compiled in 'Kale Patthar', a poetic discussion has been done on human thinking, its action and consequences, so that people can understand the reality of life by moving away from their thinking and living life with the spirit of Sarvananda in every situation. Get as many opportunities as possible to live.
Sprache: Hindi
Verlag: Repro India Limited Dez 2019, 2019
ISBN 10: 1647339006 ISBN 13: 9781647339005
Anbieter: AHA-BUCH GmbH, Einbeck, Deutschland
Taschenbuch. Zustand: Neu. Neuware.