Test log

Laboratory equipment and procedures must be qualified and validated. Every NDA/ANDA inspection will include both an evaluation of laboratory controls and procedures and an audit of some of the raw data used to generate results. These data may be located in research and development test logs. The authenticity and accuracy of data used in the development of a test method should be established. (See the Guide to Inspection of Pharmaceutical Quality Control Laboratories, July 1993.)... 

SYSTEM TYPE CLOSED TEST Log P vs -1 a straight line OPEN Pressure rise in containment Vessel TEST System tempered ... 

Give a test log to highlight any deviations from the testing... 

Trauzl Pb block test, lOg sample. No 6 cap b Kast s crusher test, lOg sample, Cu cylinder c Transmission of detonation... 

Another activity at die end of the project is die verification of all documentation. Everything (like test loggings, test reports, conformance statements, traceability matrices, requirements, etc.) is already documented precisely during the whole project, but a final check should be performed to make sure diat indeed everything is in place and has the correct status. Ideally this verification is performed by an independent person. 

Test logs in chronological order with version referencing ... 

Within a series of substituted phenoxyacetic acids, Briggs et aC noted that uptake by barley roots was optimal for the acids whose undissociated form had log values of 1 to 3 and was less for more polar and more lipophilic compounds. This uptake was due almost entirely to raised concentrations in the cell sap, for only with the most lipophilic compound tested (log Xqw4.51) could any partitioning be measured onto macerated roots from a bathing solution of pH 5.0. The pKa values of the acids were essentially similar across the series, and so these differences in accumulation were attributed to changes in the permeability ratio Fah/ a"- This ratio was optimal for 4-chlorophenoxyacetic acid (log 2.25, Pah/Fa- 4x 10 ) and declined substantially for more polar and more lipophilic analogues. 

Test Log blood lead coeff. (SE) p Value, one-tailed test... 

It will be useful to have a test log - a document or file that lets you review the tests done in the last week, or last month, or from the beginning of the program - sortable by serial number, date, or goodness (pass/fail decisions, and perhaps measured QE-FF and NEI). 

Report generation (see Section 10.7) - including masking criteria, graphics Test log - synopsis of tests sortable by date, serial number, and key results Data retrieval (both raw data and reports)... 

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