In software development, engineering, science, manufacturing, and business, it is vital for all interested people to understand and agree upon methods of obtaining data and making measurements.
It is common for a physical property to be strongly affected by the precise method of testing or measuring that property.
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The key point is to develop methods for easy validation and revalidation. Krause published a guide for analytical method transfer, comparability, maintenance and acceptance criteria for the testing of biopharmaceuticals (18).
This primer gives a review and a strategy for the validation of analytical methods for both methods developed in-house as well as standard methods, and a recommendation on the documentation that should be produced during, and on completion of, method validation.
The validation procedure in this particular article is based on requirements for EU multistate registration.
Wegscheider (13) has published procedures for method validation with a special focus on calibration, recovery experiments, method comparison and investigation of ruggedness. (14) have described how analytical methods are validated in a Japanese QC laboratory.
Representatives of the pharmaceutical and chemical industry have published papers on the validation of analytical methods.
Hokanson (9,10) applied the life cycle approach, developed for computerized systems, to the validation and revalidation of methods.
Validation of the suitability of the test method is often required.
Quality management systems usually require full documentation of the procedures used in a test.
Green (11) gave a practical guide for analytical method validation, with a description of a set of minimum requirements for a method.