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
 

1.3 Methods of inspection

The inspector uses different methods to check compliance with the national, supranational or international drug laws and regulations. Among these methods are:

Comprehensive/routine inspection. This form of inspection is generally reserved for a new pharmaceutical establishment, when an establishment is applying for permit to extend its scope of operations beyond that for which it was originally licensed, has made important changes in key personnel or is changing premises, has not been inspected for a long time (3-5 years), or when there is information (even of an informal nature) of serious lapses. Where the inspection is for a new establishment or for extension of scope of operation or because of changes in key personnel, the inspection should be announced.

 

Concise inspection. This is reserved for establishments that have previously been inspected with a view to assessing standards of good pharmacy practice. The outcome of the inspection will help in the proper assessment of the establishment. The inspection may be unannounced.

Follow-up inspection. This is normally carried out to ensure that corrective measures have been undertaken following advice and notice given during a previous inspection. Where a time limit was given for applying the corrective measures, the inspection may be unannounced.

Special inspection. This is undertaken to deal with specific complaints received about lapses or non-compliance with standards of professional practice. The inspection should preferably be unannounced.

Investigative inspection. This type of inspection is used to assess the performance of a new establishment whose scope of operation was previously unknown.

 

Any of these methods may be applied with or without prior announcement. Normally inspections should be announced but it serves a useful purpose to undertake some unannounced inspections. Follow-up, special and investigative inspections should preferably be unannounced.

Inspections should be held regularly. Premises should be inspected at least once every 12-18 months. Where contravention is often noticed, the inspection should be more frequent (e.g. every six months). For premises with a good record, less frequent inspections may be needed.

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