Test and Reference Items

The location where the study plan, samples of test and reference items, specimens, raw data, and the final report are to be stored. 

In the absence of a required retention period, the final disposition of any study materials should be documented. When samples of test and reference items and specimens are disposed of before the expiry of the required retention period for any reason, this should be justified and documented. Samples of test and reference items and specimens should be retained only as long as the quality of the preparation permits evaluation. 

Separate areas for receipts and storage of the test and reference items... 

Receipt, handling, sampling and storage of test and reference items should be clearly defined activities, with well-defined procedures. Also procedures must be provided for the records that are to be kept as evidence of good practice and the identification information on storage containers. 

Descriptive title, identification of the test and reference item, purity, stability... 

All test and reference items should be identified with a Chemical Abstracts Service registry number or other unique code. Where test items are novel compounds supplied by the sponsor of the study, there should be an agreed-upon identification system to allow the item to be tracked through the study. The composition and concentrations of prepared solutions should be known and recorded. A sample for analytical purposes of each batch of test item should be retained for all except short-term studies. This requirement has the potential to overload storage facilities very quickly, and some sensible arrangement must be made to archive samples of importance, while not giving an inspector cause to worry about inappropriate disposal of items. 

The facility should ensure that test and reference items are appropriately characterized. 

The logistics of test and reference item receipt, handling and storage have to provide for the possibility of tracing, in retrospect, the complete life cycle of any test or reference item. Thus, appropriate procedures have to be defined, adequate records have to be maintained, and proper identification of test and reference items has to be assured. 

Most problems and questions in relation to the requirements for appropriate characterisation of test and reference items are revolving around three pivotal points ... 

There are two points which need to be addressed in this context. In the first instance, the requirement for an expiry date is not confined to the labelling of test and reference items, but is also applicable to any chemicals, reagents and solutions used in a GLP compliant test facility. This issue has already be touched upon briefly in section 6 (see page 181). While there is no... 

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