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

1.1 Qualifications

Inspectors should normally be pharmacists who have working experience in community and/or hospital pharmacy. Where persons other than pharmacists are employed as drug inspectors, they should be adequately experienced in drug control affairs and suitably trained in inspectorate functions. The possibility of having part-time inspectors with specialist knowledge as part of inspection teams should also be considered.

The inspector should possess the following attributes:

- good knowledge of pharmacy, drugs, and poisons


- good knowledge of the laws and regulations to be enforced

- good command of technical terms and excellent communication skills

- awareness of the probable methods of using forged or false documents for transactions in pharmaceutical preparations and skill in determining the genuineness of documents presented for examination

- maturity, honesty and integrity

- responsible conduct which commands respect

- willingness to accept challenges

- ability to organize their own work with minimum supervision

- ability to assess facts quickly and take rational and sound decisions without delay

- ability to assess character and honesty of persons being interviewed

- good public relations image with key personnel/pharmacists in charge of premises while remaining firm, fair and resolute

- ability to hold discussions with company management at the completion of inspection

- ability to motivate others

- commitment to hard work and long hours

- ethical approach to any potential conflict of interest.


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