Practical Approaches to Method Validation and Essential Instrument Qualification - Image 1

£53.95

Wiley Practical Approaches to Method Validation and Essential Instrument Qualification

Name: Practical Approaches to Method Validation and Essential Instrument Qualification
Brand: Wiley
Price: 52.29 GBP
Availability: InStock

Pharmacy - Dispensing

Price History & Forecast

Last 89 days • 89 data points

Historical

Generating forecast...

Price Distribution

Price distribution over 89 days • 3 price levels

Days at Price

Current Price

Price Analysis

Most common price: £54 (55 days, 61.8%)

Price range: £51 - £54

Price levels: 3 different prices over 89 days

Description

Practical approaches to ensure that analytical methods and instruments meet GMP standards and requirements Complementing the authors' first book, Analytical Method Validation and Instrument Performance Verification, this new volume provides coverage of more advanced topics, focusing on additional and supplemental methods, instruments, and electronic systems that are used in pharmaceutical, biopharmaceutical, and clinical testing. Readers will gain new and valuable insights that enable them to avoid common pitfalls in order to seamlessly conduct analytical method validation as well as instrument operation qualification and performance verification. Part 1, Method Validation, begins with an overview of the book's risk-based approach to phase appropriate validation and instrument qualification; it then focuses on the strategies and requirements for early phase drug development, including validation of specific techniques and functions such as process analytical technology, cleaning validation, and validation of laboratory information management systems Part 2, Instrument Performance Verification, explores the underlying principles and techniques for verifying instrument performance―coverage includes analytical instruments that are increasingly important to the pharmaceutical industry, such as NIR spectrometers and particle size analyzers―and offers readers a variety of alternative approaches for the successful verification of instrument performance based on the needs of their labs At the end of each chapter, the authors examine important practical problems and share their solutions. All the methods covered in this book follow Good Analytical Practices (GAP) to ensure that reliable data are generated in compliance with current Good Manufacturing Practices (cGMP). Analysts, scientists, engineers, technologists, and technical managers should turn to this book to ensure that analytical methods and instruments are accurate and meet GMP standards and requirements.

Product Specifications

Brand: Wiley
Format: hardcover
ASIN: 0470121947
Category: Books > Subjects > Health, Family & Lifestyle > Medical & Healthcare Practitioners > Allied Health Professions > Pharmacy - Dispensing
Domain: Amazon UK
Release Date: 10 September 2010
Listed Since: 02 April 2007

Barcode

No barcode data available

Wiley Practical Approaches to Method Validation and Essential Instrument Qualification

Price History & Forecast

Price Distribution

Price Analysis

Description

Product Specifications

Barcode

Similar Products You Might Like

Analytical Method Validation and Instrument Performance Verification

Validating Chromatographic Methods: A Practical Guide

Method Validation in Pharmaceutical Analysis: A Guide to Best Practice

Wiley Analytical Testing for the Pharmaceutical GMP Laboratory

Analytical Chemistry in a GMP Environment: A Practical Guide

Regulated Bioanalytical Laboratories: Technical and Regulatory Aspects from Global Perspectives

Bioanalytical Aspects in Biological Therapeutics (Wiley on Pharmaceutical Science and Biotechnology: Practices, Applications and Methods)

Specification of Drug Substances and Products: Development and Validation of Analytical Methods

GMP-Qualifizierung und Validierung von Wirkstoffanlagen: Ein Leitfaden für die Praxis

Calibration in Analytical Science: Methods and Procedures

MASTERING CLEANING VALIDATION: ENSURING COMPLIANCE AND EXCELLENCE IN PHARMACEUTICAL MANUFACTURING

Sterile Processing of Pharmaceutical Products: Engineering Practice, Validation, and Compliance in Regulated Environments

GMP Compliance at Validation, Qualification & Documentation with practical case studies and templates: for Pharma / Biotech / ATMP / Medical Device

Laboratory Control System Operations in a GMP Environment

Pharmaceutical Quality by Design: A Practical Approach (Advances in Pharmaceutical Technology)

Pharmaceutical Computer Systems Validation: Quality Assurance, Risk Management and Regulatory Compliance

Specification of Drug Substances and Products: Development and Validation of Analytical Methods

Pharmaceutical Equipment Validation: The Ultimate Qualification Guidebook

Basics of Pharmaceutical Manufacturing and Quality Operations: A Comprehensive Guide

Validation in Chemical Measurement

GMP im Labor: Die Gute Herstellungspraxis im Labor praktisch umgesetzt

Validating Pharmaceutical Systems: Good Computer Practice in Life Science Manufacturing

Pharmaceutical Computer Systems Validation: Quality Assurance, Risk Management and Regulatory Compliance

Statistical Methods in Analytical Chemistry: 211 (Chemical Analysis: A Series of Monographs on Analytical Chemistry and Its Applications)