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Viser: Analytical Methods, Specifications and Control Strategies for a GxP Environment
Analytical Methods, Specifications and Control Strategies for a GxP Environment
Terrence P. Tougas, Cornelia Field, Dennis O'Connor og Rajni B. Patel
(2021)
Sprog: Engelsk
Taylor & Francis Group
2.157,00 kr.
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Detaljer om varen
- Hardback: 360 sider
- Udgiver: Taylor & Francis Group (Januar 2021)
- Forfattere: Terrence P. Tougas, Cornelia Field, Dennis O'Connor og Rajni B. Patel
- ISBN: 9781439879665
This book provides information about the analytical methods and strategies for quality control of clinical supplies and commercial products in the pharmaceutical industry. It describes the analytical methods used, presents an overview of validation and method transfer, and discusses the strategy for establishment of specifications. The text addresses the types of studies needed to support development and details a phased approach to development. It also explains how the development cycle relates to analytical development guidance on designing a control strategy and to quality by design. The authors conclude with commentary on the current regulatory environment.
Scope of Analytical Methods Used For Pharmaceutical Development and QC of Clinical Supplies and Commercial Products Types or methods used and brief description Types of studies and information needed to support development Overview of Pharmaceutical Regulatory Environment Regulatory authorities, laws, guidance documents
... Pharmacopeia and the role or standards Other organizations (IC II, Industry groups, WHO...) Development Cycle and Relationship to Analytical Development Designing a Control Strategy and Its Relationship to QbD Establishment of Specifications Validation or Analytical Procedures Current regulatory expectations Chromatography Other Methods Shortcomings of existing approaches & the desired state Method Transfer
... Pharmacopeia and the role or standards Other organizations (IC II, Industry groups, WHO...) Development Cycle and Relationship to Analytical Development Designing a Control Strategy and Its Relationship to QbD Establishment of Specifications Validation or Analytical Procedures Current regulatory expectations Chromatography Other Methods Shortcomings of existing approaches & the desired state Method Transfer
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