M2 Presswire , 09/21/2006
Overview of Pharmaceutical Product Development and Its Associated Quality System Potency Method Validation.
COPYRIGHT 2006 M2 Communications Ltd.
M2 PRESSWIRE-21 September 2006-Research and Markets: Overview of Pharmaceutical Product Development and Its Associated Quality System Potency Method Validation(C)1994-2006 M2 COMMUNICATIONS LTD RDATE:22092006
Dublin - Research and Markets (http://www.researchandmarkets.com/reports/c42485) has announced the addition of "Analytical Method Validation and Instrument Performance Verification" to their offering.
Validation describes the procedures used to analyze pharmaceutical products so that the data generated will comply with the requirements of regulatory bodies of the US, Canada, Europe and Japan. Calibration of Instruments describes the process of fixing, checking or correcting the graduations of instruments so that they comply with those regulatory bodies. This book provides a thorough explanation of both the fundamental and practical aspects of biopharmaceutical and bioanalytical methods validation.
It teaches the proper procedures for using the tools and analysis methods in a regulated lab setting. Readers will learn the appropriate procedures for calibration of laboratory instrumentation and validation of analytical methods of analysis. These procedures must be executed properly in all regulated laboratories, including pharmaceutical and biopharmaceutical laboratories, clinical testing laboratories (hospitals, medical offices) and in food and cosmetic testing laboratories.
KKey Topics Covered Include:
Method Validation for HPLC Analysis of Related Substances in Pharmaceutical Drug ProductsOverview of Pharmaceutical Product Development and Its Associated Quality SystemPotency Method ValidationDissolution Method ValidationDevelopment and Validation of Automated MethodsAnalysis of Pharmaceutical Inactive IngredientsValidation Study of JP Heavy Metal Limit TestBioanalytical Method ValidationProcurement, Qualification, and Calibration of Laboratory Instruments: An OverviewPerformance Verification of UV-Vis SpectrophotometersPerformance Verification of HPLCOperational Qualification of a Capillary Electrophoresis InstrumentLC-MS Instrument CalibrationKarl Fisher Apparatus and Its Performance VerificationThe pH Meter and Its Performance VerificationQualification of Environmental ChambersEquipment Qualification and Computer System ValidationValidation of Excel Spreadsheet
For more information visit http://www.researchandmarkets.com/reports/c42485
CONTACT: Laura Wood, Senior Manager, Research and MarketsFax: +353 1 4100 980 e-mail: press@researchandmarkets.com
((M2 Communications Ltd disclaims all liability for information provided within M2 PressWIRE. Data prepared by named party/parties. Further information on M2 PressWIRE can be obtained at http://www.presswire.net on the world wide web. Inquiries to info@m2.com)).
InfoTrac OneFile (R)
No comments:
Post a Comment