Archive location, merging and dissolution

The question of where to store all the material from studies and from test facility activities which needs to be retained can give rise to some uncertainties, which on the whole are mainly unfounded. The GLP Principles do not address the question of the specific requirements for the location of an archive, except that it should, like any other facility, be of suitable size, construction and location to meet... requirements . Therefore, there is complete freedom for every test facility to define the location of its archives and to designate the proper locations for each type of materials to be stored. 

The GLP Principles do also direct attention the one fact of business life, the event that a test facility might go out of business, while giving no advice on the way to handle the archive situation in the case of a company merger. In this second case, there is probably no need for overmuch regulation. In the event of a merger, the already archived material may either stay at the present archive location, or it may be moved to the archive of the buyer . In the former case no special measures have to be taken, while in the latter one some documentation will be needed. The reason for this necessity is that it has to be mentioned in all final reports where the different materials, raw data, samples and specimens are to be stored. Since with the move to new archive locations this statement will not be true anymore, the new location of the various materials has to be given in an amendment to each study report, which can, however, take the form of a general statement that can be declared valid for all studies of a certain time period or of a certain denomination. 

In any case, it has to be stressed that it should be possible for all material for which the GLP Principles require retention, to be retrieved and investigated during the whole period of time which the country, where the test facility is located, stipulates as the minimum time of storage. Every change in the conditions of archiving has therefore to be fully documented. Only in this way will it be possible to trace the fate of documents, records, samples and specimens even after their placement into storage. 

Non-clinical health and environmental safety studies covered by the Principles of Good Laboratory Practice include work conducted in the laboratory, in greenhouses, and in the field. 

Unless specifically exempted by national legislation, these Principles of Good Laboratory Practice apply to all non-clinical health and environmental safety studies required by regulations for the purpose of registering or licensing pharmaceuticals, pesticides, food and feed additives, cosmetic products, veterinary drug products and similar products, and for the regulation of industrial chemicals. 

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