Facilities for Handling Test and Reference Items

Of course, the storage facilities should provide adequate conditions to preserve the identity, purity and stability of the test items. Normally, storage areas at different temperature levels, for storage at room temperature or in refrigerators and deep freezers would therefore be needed. Also protection from light, humidity or oxygen may be necessary for special cases. 

When many activities of a similar kind are performed at one and the same place, and when large numbers of test items or test systems are handled within one room or area, the number of errors, mistakes and mix-ups would probably increase exponentially. A proper separation is therefore necessary to provide an appropriate guarantee for the correct conduct of studies and for their integrity. 

In providing guidance on what to separate, how to separate, and to what extent to separate, GLP aims on the one hand at minimising the risk for annoying mistakes to happen, and on the other hand at maximising the trust in the correctness of study conduct, when - even in retrospect - it can be assumed that no chance exists for mix-ups to have occurred. 

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