WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 885 - Thirty-fifth Report
(1999; 168 pages) [Spanish] View the PDF document
Table of Contents
View the documentWHO Expert Committee on Specifications for Pharmaceutical Preparations
View the document1. Introduction
Open this folder and view contents2. The international pharmacopoeia and related issues
Open this folder and view contents3. International Chemical Reference Substances and Infrared Reference Spectra
Open this folder and view contents4. Quality control - national laboratories
Open this folder and view contents5. Good manufacturing practices
Open this folder and view contents6. Quality systems and inspection
Open this folder and view contents7. Other quality assurance topics
Open this folder and view contents8. Nomenclature and terminology
Open this folder and view contents9. Legal aspects of pharmaceuticals
Open this folder and view contents10. Regulatory issues
Open this folder and view contents11. Training activities
View the document12. Pharmaceuticals contaminated with diethylene glycol
View the documentAcknowledgements
View the documentReferences
View the documentAnnex 1. List of available International Chemical Reference Substances1
View the documentAnnex 2. List of available International Infrared Reference Spectra1
Open this folder and view contentsAnnex 3. General guidelines for the establishment, maintenance and distribution of chemical reference substances
Open this folder and view contentsAnnex 4. Good manufacturing practices: authorized person - role, functions and training
Open this folder and view contentsAnnex 5. Good manufacturing practices: supplementary guidelines for the manufacture of pharmaceutical excipients
Close this folderAnnex 6. Guidelines for inspection of drug distribution channels
View the documentIntroductory note
View the documentGeneral considerations
View the documentGlossary
Close this folder1. Drug inspectors
View the document1.1 Qualifications
View the document1.2 Organizational aspects
View the document1.3 Methods of inspection
View the document1.4 Reference/information sources
Open this folder and view contents2. Inspection of establishments in the drug distribution chain
View the documentReferences
View the documentSelected further reading
View the documentAppendix 1. Checklist for inspection and the preparation of a report
View the documentAppendix 2. Guidance on sampling
View the documentAppendix 3. Guidance for inspection when pharmaceutical products are suspected to be counterfeit, spurious or substandard
View the documentAppendix 4. Sample receipt form
View the documentAnnex 7. Good pharmacy practice in community and hospital pharmacy settings
Open this folder and view contentsAnnex 8. National drug regulatory legislation: guiding principles for small drug regulatory authorities
Open this folder and view contentsAnnex 9. Provisional guidelines for developing training programmes: inspection and examination of counterfeit pharmaceuticals
View the documentWorld Health Organization Technical Report Series
View the documentSelected WHO Publications of Related Interest
View the documentBack Cover

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,

(iv) conclusions.


(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.


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