Big Chemical Encyclopedia

Chemical substances, components, reactions, process design ...

Articles Figures Tables About

Method Validation and Sample Analysis in a Controlled Laboratory Environment

Method Validation and Sample Analysis in a Controlled Laboratory Environment [Pg.539]

Definitions of the basic concept of validation can vary from single fine sentences to much longer descriptions. Here one of the longer descriptions is quoted (Thompson 2002) since it appears that it better addresses the complexity of the real situation at the expense of some measure of perceived elegance . [Pg.539]

Trace Quantitative Analysis by Mass Spectrometry Robert K. Boyd, Cecilia Basic, Robert A. Bethem 2008 John Wiley Sons, Ltd. ISBN 978-0-470-05771-1 [Pg.539]

Elucidation of how the general principles underlying the concept of validation should be expressed in practice is an evolving process, as exemplified by the ongoing evolution of validation requirements for bioanalytical assays in the pharmaceutical industry (Shah 1992, 2000 FDA 2001 Viswanathan 2007). The complementary principle of fitness for purpose (Section 9.2) applies not only to the assay method but also to the validation process itself. Procedures that are considered to be fit for purpose in validation of an analytical method to be used in drug development, for example, need not necessarily apply to, e.g., methods used to screen pesticide residues in foodstuffs. As noted in Section 9.2, this point of view appears to be consistent with the definition of validation applied to all measurements (ISO 1994) Validation Confirmation by examination and provision of objective evidence that the particular requirements for a specified intended use are fulfilled. Of course, some basic principles are common to all validation schemes. [Pg.540]


See other pages where Method Validation and Sample Analysis in a Controlled Laboratory Environment is mentioned: [Pg.64]    [Pg.10]    [Pg.343]    [Pg.777]    [Pg.320]    [Pg.567]   


SEARCH



A samples

A sampling methods

Analysis control

Control methods

Control sample

Controllability analysis

Environment Methods

Environment analysis

Environment controlled

Environment samples

Environment sampling

Laboratory analysis

Laboratory control sample

Laboratory controls

Laboratory environment

Laboratory methods

Laboratory sample

Laboratory sampling

Method in laboratory

Sample methods

Sample validity

Sampling and Sample Analysis

Sampling controller

Sampling methods

Sampling valid

Validated Sample Analysis

Validated methods

Validation sample

© 2024 chempedia.info