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Author: Syed Imtiaz Haider
Publisher: CRC Press
Published: 2010-05-24
Total Pages: 608
ISBN-13: 1439826617
DOWNLOAD EBOOKDuring the past decades, enormous progress and enhancement of pharmaceutical manufacturing equipment and its use have been made. And while there are support documents, books, articles, and online resources available on the principles of cleaning and associated processing techniques, none of them provides a single database with convenient, ready-to-
Author: Frederick J. Carleton
Publisher: Marcel Dekker
Published: 1986
Total Pages: 728
ISBN-13:
DOWNLOAD EBOOKAuthor: Shiv Shankar Shukla
Publisher: Springer Nature
Published: 2023-02-14
Total Pages: 216
ISBN-13: 9811990026
DOWNLOAD EBOOKThis up-to-date and unique monograph covers the different aspects of pharmaceutical validation, calibration, qualification and documentation. It discusses the various methods and processes under all these heads. It includes eight major sections and exhaustively covers each topic.The book includes interesting and timely topics like the ‘Validation of herbals’ considering the increasing reliance on herbal medicines. It includes a section of validation of dosage forms, which is an essential topic for any pharmaceutical scientist. The chapters provide lucid illustrations, figures, flowcharts and other diagrams to facilitate understanding. A final section on 'expert opinion' provides a rundown about the global scenario to the readers. The book serves as a complete reference material for students, researchers and industry experts in the field of pharmaceutical sciences, medicinal chemistry and pharmacology.
Author: Destin A. LeBlanc
Publisher: CRC Press
Published: 2022-12-23
Total Pages: 216
ISBN-13: 1000835596
DOWNLOAD EBOOKPharmaceutical manufacturers and upper management are encouraged to meet the challenges of the science-based and risk-based approaches to cleaning validation. Using some of the principles and practices in this volume will help in designing a more effective and efficient cleaning validation program. Features • Timely coverage of cleaning validation for the pharmaceutical industry, a dynamic area in terms of health-based limits. • The author encourages pharmaceutical manufacturers, and particularly upper management, to meet the challenges of the science-based and riskbased approaches to cleaning validation. • Draws on the author’s vast experience in the field of cleaning validation and hazardous materials. • Discusses EMA vs. ISPE on Cleaning Limits and revised Risk-MaPP for highly hazardous products in shared facilities. • A diverse list of topics from protocol limits for yeasts and molds to cleaning validation for homeopathic drug products.
Author: Rajiv Kohli
Publisher: William Andrew
Published: 2014-11-18
Total Pages: 207
ISBN-13: 0323311458
DOWNLOAD EBOOKAs device sizes in the semiconductor industries are shrinking, they become more vulnerable to smaller contaminant particles, and most conventional cleaning techniques employed in the industry are not as effective at smaller scales. The book series Developments in Surface Contamination and Cleaning as a whole provides an excellent source of information on these alternative cleaning techniques as well as methods for characterization and validation of surface contamination. Each volume has a particular topical focus, covering the key techniques and recent developments in the area. The chapters in this Volume address the sources of surface contaminants and various methods for their collection and characterization, as well as methods for cleanliness validation. Regulatory aspects of cleaning are also covered. The collection of topics in this book is unique and complements other volumes in this series. Edited by the leading experts in small-scale particle surface contamination, cleaning and cleaning control, these books will be an invaluable reference for researchers and engineers in R&D, manufacturing, quality control and procurement specification situated in a multitude of industries such as: aerospace, automotive, biomedical, defense, energy, manufacturing, microelectronics, optics and xerography. Provides a state-of-the-art survey and best-practice guidance for scientists and engineers engaged in surface cleaning or handling the consequences of surface contamination Addresses the continuing trends of shrinking device size and contamination vulnerability in a range of industries, spearheaded by the semiconductor industry and others Includes new regulatory aspects
Author: Igor Gorsky
Publisher: Academic Press
Published: 2019-11-27
Total Pages: 300
ISBN-13: 012809446X
DOWNLOAD EBOOKPrinciples of Parenteral Solution Validation: A Practical Lifecycle Approach covers all aspects involved in the development and process validation of a parenteral product. By using a lifecycle approach, this book discusses the latest technology, compliance developments, and regulatory considerations and trends, from process design, to divesting. As part of the Expertise in Pharmaceutical Process Technology series edited by Michael Levin, this book incorporates numerous case studies and real-world examples that address timely problems and offer solutions to the daily challenges facing practitioners in this area. - Discusses international and domestic regulatory considerations in every section - Features callout boxes that contain points-of-interest for each segment of the audience so readers can quickly find their interests and needs - Contains important topics, including risk management, the preparation and execution of properly designed studies, scale-up and technology transfer activities, problem-solving, and more
Author: Carmen Medina
Publisher: CRC Press
Published: 2003-12-09
Total Pages: 604
ISBN-13: 0824740785
DOWNLOAD EBOOKThis text lists the necessary steps for meeting compliance requirements during the drug development process. It presents comprehensive approaches for validating analytical methods for pharmaceutical applications.
Author: Mr. Manohar A. Potdar
Publisher: Pragati Books Pvt. Ltd.
Published: 2006
Total Pages: 424
ISBN-13: 9788185790596
DOWNLOAD EBOOKAuthor: Joachim Ermer
Publisher: John Wiley & Sons
Published: 2006-03-06
Total Pages: 418
ISBN-13: 3527604472
DOWNLOAD EBOOKAdopting a practical approach, the authors provide a detailed interpretation of the existing regulations (GMP, ICH), while also discussing the appropriate calculations, parameters and tests. The book thus allows readers to validate the analysis of pharmaceutical compounds while complying with both the regulations as well as the industry demands for robustness and cost effectiveness. Following an introduction to the basic parameters and tests in pharmaceutical validation, including specificity, linearity, range, precision, accuracy, detection and quantitation limits, the text focuses on a life-cycle approach to validation and the integration of validation into the whole analytical quality assurance system. The whole is rounded off with a look at future trends. With its first-hand knowledge of the industry as well as regulating bodies, this is an invaluable reference for analytical chemists, the pharmaceutical industry, pharmaceutists, QA officers, and public authorities.
Author: Lucia Clontz
Publisher: CRC Press
Published: 2008-10-14
Total Pages: 344
ISBN-13: 1420053493
DOWNLOAD EBOOKIn recent years, the field of pharmaceutical microbiology has experienced numerous technological advances, accompanied by the publication of new and harmonized compendial methods. It is therefore imperative for those who are responsible for monitoring the microbial quality of pharmaceutical/biopharmaceutical products to keep abreast of the latest c
