Reference item

Identification of the regulatory study, the test item, and the reference item... 

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. 

The status of test substances must be well-defined and recorded, including their identity, purity and properties. Test items and reference items should be stored separately to avoid contamination and reduce the potential for a mix-up . 

Test item is the article that is the subject of a study. The reference item provides the basis for comparison. Batch means a specific quantity of the test or reference item expected to have a uniform character. Vehicle is the carrier of the test item. 

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. 

Identification of each batch of the test or reference items... 

Title, nature and purpose of the study, test item identity, reference item used etc. 

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

Storage (of samples, reference items, raw data, final reports etc.)... 

The most frequently used tests in quality control in the flavour industry are paired-sample comparison tests, and triangle tests, which are often combined with the description of deviation from a reference item. For the selection and training of panellists, further test methods are used, for example ranking tests for colour, taste and odour, threshold detections (taste, off-flavour), colour blindness tests and odour identification tests [6]. 

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 study is performed according to a plan approved (by dated signature) by the study director and verified for CLP compliance by the QA unit. Some countries also require formal approval by the test facility management and the sponsor. The plan should usually contain identification of the study, the test item and reference item, information concerning the sponsor and the test facility, dates, test methods, documents and materials to be retained, and other issues that have been identified. 

The equipment list is used in conjunction with the process flow diagram (or P ID). Each item of equipment on the flowsheet should be assigned a unique reference number, and that number is used to cross-reference items in the equipment list. Particular letters may be used to identify similar items of equipment, e.g. reactors as Rxxx, pumps as P-001, etc. 

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

Identification of the study, the test item and reference item (descriptive title). 

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