Paragraph 9 Test and reference items

Purpose: to determine whether the test facility has procedures designed—

The inspector should check that—

• —there are written records on the receipt (including identification of the person responsible), and for the handling, sampling, usage and storage of test and reference items,

• —test and reference item containers are properly labelled,

• —storage conditions are appropriate to preserve the concentration, purity and stability of the test and reference items,

• —there are written records on the detemination of identity, purity, composition, stability, and for the prevention of contamination of test and reference items, where applicable,

• —there are procedures for the determination of the homogeneity and stability of mixtures containing test and reference items, where applicable,

• —containers holding mixtures (or dilutions) of the test and reference items are labelled and that records are kept of the homogeneity and stability of their contents, where applicable,

• —when the test is of longer than four weeks duration, samples from each batch of test and reference items have been taken for analytical purposes and that they have been retained for an appropriate time,

• —procedures for mixing substances are designed to prevent errors in identification or cross-contamination.