(1999; 168 pages) [Spanish]
1.2 Organizational aspects
Inspectors should be embedded in an organization, usually called an inspectorate, which ensures the following aspects:
• A job description which describes the duties of the inspector.
• Proper reporting: inspectors should report either to the drug regulatory authority or to the pharmaceutical department (chief pharmacist) of the ministry of health.
• Uniformity of approach:
(a) Regular meetings of inspectors, in which experiences on the job are exchanged, will help promote a uniform approach to inspection as well as enhance the performance of the inspectors.
(b) Inspectors should work according to a work plan and to Standard Operating Procedures (SOPs).
(c) Inspection reports should preferably be in three or four parts:
(i) date of inspection and general information on the establishment inspected,
(ii) description of the inspection activities undertaken, including analytical data of samples taken,
(iii) observations and recommendations,
(d) Inspectors should be encouraged to submit weekly reports of work to headquarters.
• Total coverage of the country. This can be achieved by:
(a) dividing the country into defined areas for the purpose of inspection and placing an inspector in charge of a defined area for the purpose of inspecting wholesale, community and hospital pharmacies, and clinics,
(b) inspection of ports and border posts in a defined area.
• Total coverage of the field. The inspector will be expected to inspect establishments such as:
(a) pharmaceutical manufacturers in respect of drug distribution,
(b) pharmaceutical importers/exporters,
(c) pharmaceutical wholesalers and retailers,
(d) hospital pharmacies/clinics,
(e) ports and international border posts,
(f) drug warehouses, stores and unauthorized markets.
(Note: The existence of unauthorized markets for the distribution of drugs poses considerable health hazards. The inspectors should, with the assistance of task forces if necessary, investigate the extent of the unauthorized market, the types of drugs distributed and supplied, and the sources of the drugs. Where possible, unauthorized markets for drugs should be prohibited through effective inspectorate activities. Inspectors should also investigate the sources of supply of suspect counterfeit or substandard pharmaceutical products.)
• Cooperation with other agencies. The inspector will be expected to interact and cooperate with other interested parties such as:
(a) industrial, community and hospital pharmacists,
(b) management and supervisory staff of pharmaceutical establishments and hospitals,
(c) medical practitioners, dentists, veterinarians, nurses and midwives and other health workers,
(d) public analysts,
(e) ministry of justice officials and court officials,
(f) drug law enforcement officers including the police and customs,
(g) officers of port authorities, clearing agents at the ports, importers and exporters,
(h) members of the public,
(i) staff of faculties of medicine/pharmacy,
(j) foreign drug regulatory authorities.
• Independence. Inspectors should, for example, have the use of official vehicles.
• Adherence to a code of inspection.