Analysis and outcome
Table I: Comparison between summary of groups.
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For a comparison between groups (most frequently cited deficiencies and most severe deficiencies), please see Table I. In
general, PIC/S Participating Authorities use different GMP deficiency classification models in the following ways:
- Some use the model developed by the UK MHRA.
- Some use a model based on the Chapters and Annexes of the PIC/S GMP Guide.
- Some have their own classification methodology.
- Some members do not have formal analysis trending on GMP deficiencies.
There is no significant differences among regions in terms of the way GMP deficiencies are inspected and cited. There is,
however, a correlation between the most frequent GMP deficiency classes and the most severe GMP deficiency classes. This implies
that there is harmonization across all PIC/S Participating Authorities.
The 10 most frequently cited GMP deficiency classes means that the industry is weak in these areas and inspectors should communicate
more effectively and efficiently to the industry on such weaknesses.
Different level of details of the deficiency classes model was noted. A model that could be accepted by most PIC/S participating
authorities may be required going forward.
Some of the most frequently cited GMP deficiencies may due to ease of detection as part of the inspection process (e.g., documentation–manufacturing
was the most frequently cited deficiency). The design and maintenance of premises ranked second, which may relate to aged
buildings or saving on maintenance budget.
Recommendations
The following items were recommended and presented to all participants in November 2011.
Data trending.
Some agencies did not conduct such GMP deficiencies analysis/trending exercise over a defined period of time. It is recommended
that all PIC/S Participating Authorities should implement such an exercise for analysis and trending within a defined period
(e.g., annually) and subsequently, for trending across different years.
Common model.
It would be useful for all PIC/S Participating Authorities to use a common GMP deficiency classification model. PIC/S should
consider developing a PIC/S common GMP deficiency classification model.
Annual reviews.
It may be useful to adopt this exercise and discussion on common GMP deficiencies throughout industry at PIC/S level on an
annual basis. Data from each PIC/S Participating Authority could be collated for analysis. The collated output may be used
to identify common specific GMP areas to be focused on for training and to help pull resources together within PIC/S.
Conclusion
There is a correlation between the most frequent GMP deficiencies classes and the most severe GMP deficiencies classes. This
correlation implies that there is harmonization across all PIC/S Participating Authorities.
Hans Smallenbroek is the former PIC/S Chairman and a senior GMP Inspector in The Netherlands with the Health Care Inspectorate. Boon Meow Hoe is a senior GMP Inspector in Singapore with the Health Sciences Authority.
The topic of this article will be presented during the PDA Europe-PIC/S workshop 2012, taking place May 9–10, 2012 in Geneva,
Switzerland.
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