WHO TRS (Technical Report Series) 908, 2003 Annex 6


Guidance on Good Manufacturing Practices (GMP): inspection report

Guidance on Good Manufacturing Practices (GMP): inspection report

When a site at which pharmaceutical products are manufactured is inspected, the inspector(s) responsible must draw up a report containing the items listed below. Where relevant, the appropriate section of the WHO GMP (Annex 4) is indicated. 

A. Manufacturer 

(a) Name of inspected manufacturer. 
(b) Address of inspected manufacturer (including telephone, fax, email and 24-hour telephone numbers).  
(c) Address of manufacturing site if different from that given above. 
(d) Site number (e.g. site master file or number allocated by the responsible authority). 
(e) Manufacturing licence number, if applicable. 
(f) Activities. 
(g) Pharmaceutical products manufactured. 
(h) Key personnel.
 (i) Key persons met.

B. Inspection details 

(a) Date(s) of inspection(s). 
(b) Previous inspection date. 
(c) Type of inspection. 
(d) Scope of inspection. 
(e) The regulatory authority. 
(f) GMP guidelines used for assessing compliance. 
(g) For foreign inspections state whether, the national regulatory authority (NRA) of the country where the inspection took place was informed and whether it took part in the inspection. 
(h) Brief report of inspection activities undertaken. 
(i) Samples taken and results obtained. 
(j) Assessment of the site master file. 
(k) GMP-related recalls from the market of any product in the last 2 years.

See below PDF for complete details:

WHO TRS (Technical Report Series) 908, 2003 Annex 6:

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