The WHO Expert Committee on Specifications for Pharmaceutical Preparations adopted in its thirty-eighth report in 2003 the Guidelines for preparing a
laboratory information file (WHO Technical Report Series, No. 917, 2003, Annex 5).
The content of these guidelines is closely related to WHO guidelines on good practices for pharmaceutical quality control laboratories, which have recently been revised (the revised version was adopted by the WHO Expert Committee at its forty-fourth meeting in 2009).
The WHO Expert Committee on Specifications for Pharmaceutical Preparations discussed the need for a revision of both sets of guidelines at its forty-third meeting in 2008 and recommended that if the Guidelines for good practices for national pharmaceutical control laboratories were revised, the Guidelines for preparing a laboratory information file should be revised accordingly.
On the basis of the above and following the usual consultation process, the following text will replace the previously published guidelines.