Planning, process and performance

The survey showed that all the countries have planned GMP inspections. These plans are generally based on regulatory requirements relating to frequency of inspection. For instance, in the Netherlands, manufacturing plants are inspected at least once every two years. For Venezuela, the plan is activity-based it is set in terms of the number of inspections to be conducted per month. But most dmg regulatory authorities determine statutory frequencies for GMP inspection by considering the number of manufacturing plants. 

The TGA uses a more refined system for setting inspection frequency, based on product type and on manufacturer type. The risk-management approach applied to licensing is 

Information on implementation of GMP inspection plans is available in only some of the countries. Where data exist, they indicate that plans were successfully followed or even exceeded their targets. This applies to Cuba, Malaysia, the Netherlands, Uganda, Venezuela and Zimbabwe. For Cyprus, however, inspections of domestic plants fell short of the planned values. Cyprus has 10 domestic manufacturers, and nine inspections were planned, but in 1997 only seven were carried out. The Netherlands has 86 manufacturers and 28 inspections were planned in 1998 all of them were carried out. Venezuela has 41 manufacturers and 23 inspections were planned in 1997, of which 35 were carried out. So a low implementation rate does not necessarily indicate a low inspection rate. Enforcement measures are available in case of non-compliance in Cyprus, Estonia, Malaysia, Tunisia, Uganda, Venezuela and Zimbabwe. In Cuba, no enforcement measures are specified for failure to comply with GMP standards. Comparatively speaking, there is less likely to be a workplan for inspection of distribution channels than there is for GMP inspection. Only four countries — Cyprus, Estonia, Uganda and Venezuela — carry out inspection of distribution channels based on such a plan. 

Technical Working Group on GMP, including NPCB and industry representatives 

The types of violation found by inspecting distribution channels, and the types of enforcement measure used by countries are summarized in Table 7.2. 

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