Author: Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 34
Book Description
Guideline for Submitting Samples and Analytical Data for Methods Validation
Author: Guidelines for Submitting Samples and Analytical Data for Methods Validation
Author: Guideline for Submitting Samples and Analytical Data for Methods Validation
Author: Guideline on General Principles of Process Validation
Author: Publisher:
ISBN:
Category : Medical instruments and apparatus industry
Languages : en
Pages : 32
Book Description
Guideline for Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Substances
Author: Bacteriological Analytical Manual
Author: United States. Food and Drug Administration. Division of MicrobiologyPublisher:
ISBN:
Category : Microbiology
Languages : en
Pages : 180
Book Description
Analytical Method Development and Validation
Author: Michael E. SwartzPublisher: CRC Press
ISBN: 9780824701154
Category : Science
Languages : en
Pages : 100
Book Description
Describes analytical methods development, optimization and validation, and provides examples of successful methods development and validation in high-performance liquid chromatography (HPLC) areas. The text presents an overview of Food and Drug Administration (FDA)/International Conference on Harmonization (ICH) regulatory guidelines, compliance with validation requirements for regulatory agencies, and methods validation criteria stipulated by the US Pharmacopia, FDA and ICH.
Handbook of Analytical Validation
Author: Michael E. SwartzPublisher: CRC Press
ISBN: 142001448X
Category : Medical
Languages : en
Pages : 218
Book Description
Written for practitioners in both the drug and biotechnology industries, the Handbook of Analytical Validation carefully compiles current regulatory requirements on the validation of new or modified analytical methods. Shedding light on method validation from a practical standpoint, the handbook:Contains practical, up-to-date guidelines for analyti
Federal Register
Author: Publisher:
ISBN:
Category : Administrative law
Languages : en
Pages : 1366
Book Description
Development and Validation of Analytical Methods
Author: Christopher M. RileyPublisher: Elsevier
ISBN: 9780080530352
Category : Science
Languages : en
Pages : 349
Book Description
The need to validate an analytical or bioanalytical method is encountered by analysts in the pharmaceutical industry on an almost daily basis, because adequately validated methods are a necessity for approvable regulatory filings. What constitutes a validated method, however, is subject to analyst interpretation because there is no universally accepted industry practice for assay validation. This book is intended to serve as a guide to the analyst in terms of the issues and parameters that must be considered in the development and validation of analytical methods. In addition to the critical issues surrounding method validation, this book also deals with other related factors such as method development, data acquisition, automation, cleaning validation and regulatory considerations. The book is divided into three parts. Part One, comprising two chapters, looks at some of the basic concepts of method validation. Chapter 1 discusses the general concept of validation and its role in the process of transferring methods from laboratory to laboratory. Chapter 2 looks at some of the critical parameters included in a validation program and the various statistical treatments given to these parameters. Part Two (Chapters 3, 4 and 5) of the book focuses on the regulatory perspective of analytical validation. Chapter 3 discusses in some detail how validation is treated by various regulatory agencies around the world, including the United States, Canada, the European Community, Australia and Japan. This chapter also discusses the International Conference on Harmonization (ICH) treatment of assay validation. Chapters 4 and 5 cover the issues and various perspectives of the recent United States vs. Barr Laboratories Inc. case involving the retesting of samples. Part Three (Chapters 6 - 12) covers the development and validation of various analytical components of the pharmaceutical product development process. This part of the book contains specific chapters dedicated to bulk drug substances and finished products, dissolution studies, robotics and automated workstations, biotechnology products, biological samples, analytical methods for cleaning procedures and computer systems and computer-aided validation. Each chapter goes into some detail describing the critical development and related validation considerations for each topic. This book is not intended to be a practical description of the analytical validation process, but more of a guide to the critical parameters and considerations that must be attended to in a pharmaceutical development program. Despite the existence of numerous guidelines including the recent attempts by the ICH to be implemented in 1998, the practical part of assay validation will always remain, to a certain extent, a matter of the personal preference of the analyst or company. Nevertheless, this book brings together the perspectives of several experts having extensive experience in different capacities in the pharmaceutical industry in an attempt to bring some consistency to analytical method development and validation.
