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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.
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Paperback. Zustand: new. Paperback. Math by Rishabh: Logarithms and Exponents Problem Solver is your essential guide to mastering powers, indices, and logarithms-from basics to advanced problem-solving.Designed for students preparing for IB Mathematics (AA & AI), Cambridge A-Level, AP Calculus, SAT, IIT-JEE, and other competitive or university-level exams, this book focuses on developing deep conceptual clarity, fast calculation, and exam precision.Inside, you'll find: Step-by-step lessons and guided examplesFoundation, intermediate, and challenge-level exercisesCommon pitfalls and visual logic explanationsStrategies for solving equations of the form a^x = bWritten by Rishabh Kumar-an international math mentor and alumnus of IIT Guwahati and the Indian Statistical Institute-this book is part of the Math by Rishabh Problem Solver Series.Explore the full series and apply for one-on-one mentorship at: / This item is printed on demand. Shipping may be from multiple locations in the US or from the UK, depending on stock availability.
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In den WarenkorbPaperback. Zustand: New.
Sprache: Englisch
Verlag: LAP LAMBERT Academic Publishing, 2019
ISBN 10: 6200458065 ISBN 13: 9786200458063
Anbieter: Books Puddle, New York, NY, USA
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Sprache: Englisch
Verlag: Packt Publishing Limited, GB, 2021
ISBN 10: 1800209444 ISBN 13: 9781800209442
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In den WarenkorbPaperback. Zustand: New. Building production-ready enterprise applications can be a challenging task due to the over-abundance of tools and their different versions that make app development complex. This book simplifies the process with an end-to-end road map for building enterprise applications from scratch using the latest features of .NET Core 5 and C# 9.
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In den WarenkorbPAP. Zustand: New. New Book. Delivered from our UK warehouse in 4 to 14 business days. THIS BOOK IS PRINTED ON DEMAND. Established seller since 2000.
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In den WarenkorbPaperback. Zustand: Brand New. 128 pages. Hindu language. 5.50x0.30x8.50 inches. In Stock.
Sprache: Englisch
Verlag: LAP LAMBERT Academic Publishing, 2019
ISBN 10: 6200458065 ISBN 13: 9786200458063
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In den WarenkorbZustand: New.
Sprache: Englisch
Verlag: LAP LAMBERT Academic Publishing, 2023
ISBN 10: 6206845524 ISBN 13: 9786206845522
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