WHO guidelines for preparing a laboratory information file
Background:
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 fi le should be revised accordingly.
On the basis of the above and following the usual consultation process, the following text w ill replace
the previously published guidelines.
Click on the following title for full details: pdf
Table of Contents
3. Control of
documentation and records
10. Validation of analytical
procedures
11. Investigation of
out-of-specification results
12. Stability testing
(where applicable)
13. Microbiological
testing (where applicable)
WHO TRS (Technical Report Series) 961, 2011 Annex 13:
