Principles of Parenteral Solution Validation

• Author : Igor Gorsky,Harold S. Baseman
• Publisher : Academic Press
• Release : 27 November 2019

Principles 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

• Author : Hazel Aranha,Humberto Vega-Mercado
• Publisher : CRC Press
• Release : 13 March 2023

This handbook provides an in-depth review of information across the developmental spectrum of gene and cell therapy products. From introductory information to state-of-the-art technologies and concepts, the book provides insights into upstream processes such as vector design and construction, purification, formulation and fill/finish as well as delivery options. Planning steps for compliance with current good manufacturing practice (CGMP) to readiness for chemistry, manufacturing, and controls (CMC) are also discussed.This book wraps up with examples of successes and pitfalls

• Author : Anonim
• Publisher : Amer Soc Health-System Pharmacists
• Release : 28 March 1995

• Author : Ira R. Berry,Robert A. Nash
• Publisher : CRC Press
• Release : 29 January 1993

Updated to reflect current good manufacturing practice (CGMP) regulations, this text discusses current concepts in validation. New topics covered include: validation of cleaning systems and computer systems; equipment and water systems validation; and lyophilized and aerosol product validation.

• Author : Bernard T. Loftus,Robert A. Nash
• Publisher : Marcel Dekker
• Release : 28 March 1984

• Author : American Society of Health-System Pharmacists
• Publisher : Unknown
• Release : 28 March 2023

• Author : American Society of Health-System Pharmacists
• Publisher : Unknown
• Release : 28 March 2023

• Author : Michael J. Akers
• Publisher : CRC Press
• Release : 19 April 2016

Sterile Drug Products: Formulation, Packaging, Manufacturing, and Quality teaches the basic principles of the development and manufacture of high quality sterile dosage forms. The author has 38 years of experience in the development and manufacture of sterile dosage forms including solutions, suspensions, ophthalmics and freeze dried products. This book is based on the courses he has delivered for over three decades, to over 3000 participants, and is intended to remain relevant for the indefinite future even as new technologies and new applications

• Author : Seymour Stanton Block
• Publisher : Unknown
• Release : 28 March 1983

Now in its thoroughly revised, updated Fifth Edition, this volume is a comprehensive, practical reference on contemporary methods of disinfection, sterilization, and preservation and their medical, surgical, and public health applications. More than a third of this edition's chapters cover subjects never addressed in previous editions. New topics covered include recently identified pathogens, microbial biofilms, use of antibiotics as antiseptics, synergism between chemical microbicides, pulsed-light sterilization of pharmaceuticals, and new methods for medical waste management. Close attention is given to

• Author : Frederick J. Carleton,James P. Agalloco
• Publisher : Marcel Dekker
• Release : 28 March 1986

• Author : Antoine Al-Achi,Mali Ram Gupta,William Craig Stagner
• Publisher : John Wiley & Sons
• Release : 11 February 2013

Focusing on the application of physical pharmacy, drug design, and drug regulations as they relate to produce effective dosage forms for drug delivery, Integrated Pharmaceutics provides a comprehensive picture of pharmaceutical product design, describing the science and art behind the concepts of dosage form development. Combining physical pharmacy, product design, and regulatory affairs issues in a single book, the authors address topics governing drug regulations of United States, European, and Japanese agencies and detail new regulatory guidelines, including quality by

• Author : Robert F. Morrissey,G. Briggs Phillips
• Publisher : Springer
• Release : 28 February 1993

Includes as many case studies as the contributors could identify, with the goal of answering questions that arise as a result of conducting day-to-day sterilization activities. Discussion of the theory of microbial inactivation and the philosophy of sterilization validation is followed by practical information on methods of interest to a broad audience. Chapters on special considerations for ethylene oxide, packaging of sterile products, contract sterilization, and regulations complete the coverage. Annotation copyright by Book News, Inc., Portland, OR

• Author : E. Clyde Buchanan,Philip J. Schneider
• Publisher : Unknown
• Release : 28 March 2023

Rev. ed. of: Principles of sterile product preparation / E. Clyde Buchanan ... [et al.]. 1995.

• Author : Jens Thurø Carstensen
• Publisher : Marcel Dekker
• Release : 28 March 1995

Combining basic theory, current industrial practice, and useful regulatory aspects in an original overview of pharmaceutical stability, this thoroughly rewritten and enlarged reference/text examines data analysis of the packaged drug's stability, experimental methods for achieving stable marketed products, and the stability principles of drugs in dissolved, dispersed, and solid states.

• Author : Anonim
• Publisher : Unknown
• Release : 28 March 1994