(1999; 168 pages) [Spanish]
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.