Guidelines on pre-approval inspections
General:
The advice provided here extends that given in the “Provisional guidelines on the inspection of pharmaceutical manufacturers” (1). The objectives of an inspection, as given in the introduction to the guidelines, are:
— to control and enforce compliance with general good manufacturing practices (GMP) (2); and
— to authorize the manufacture of specific pharmaceutical products, normally in response to a licensing application.
These guidelines are applicable mainly to inspections of the first type, whether performed as a condition for the issue of a manufacturing licence/authorization, or on a periodic, routine basis. They are essentially concerned with inspections of manufacturing and quality control facilities conducted before a marketing authorization (product licence or registration) for a pharmaceutical product is granted.
See pdf below for complete guidelines:
WHO TRS (Technical Report Series) 902, 2002 Annex 7: pdf
