From Mr J. Sharp, Hon MRPharmS
SIR,—The report from the Medical Control Agency on "Regulatory inspection findings for 1998/99" (PJ,November 4, p686) raises a number of interesting questions, not the least of which is that of the cost-effectiveness of regulatory inspections of pharmaceutical manufacturers. The report states that "the object of inspection is to contribute to the protection of public health through the assessment of compliance by manufacturers and distributors of medicines with standards of good manufacturing practice and good distribution practice". However, Table 2 of the report demonstrates a steady increase in the number of "serious deficiencies" noted per inspection in UK, from 1995/96 to 1998/99. In their text, the authors acknowledge this trend,
but are only able to declare that "it is not possible to reach any firm conclusions based on these findings at this stage" and "increases in the number of product-related inspections and the number of unannounced inspections carried out in recent years may be contributory factors towards an overall increase in the number of reported deficiencies". As a response to an obviously unsatisfactory trend, these comments are both confusing and, surely, inadequate. For example, what, specifically, are "product-related inspections"? Are not all inspections related to the manufacture and distribution of medicinal products? Are we really to assume that when manufacturers are aware in advance that the inspectors are coming they can create de novo "quality system documentation", remove (or conceal) all "potential for chemical/physical/microbial contamination" and so on, only to abandon such measures once the inspectors have departed?
There are at least three possible explanations for this disturbing trend towards increasing failure to comply with GMP requirements: standards within UK industry are indeed dipping, the MCA is getting better at unearthing deficiencies, or the MCA is applying stricter standards.
The MCA would make its report more meaningful if it would express a positive opinion as to which is the correct explanation.
In this context it is both relevant and interesting to note that Tetzlaff, an erstwhile titan of the United States Food and Drug Administration, reported recently to the annual conference of the Parenteral Society that, in 1999, the FDA recorded an "all time record" for enforcement actions (recalls, arrests and convictions, "consent decrees" and "warning letters"). It would thus appear that, on both sides of the Atlantic it might well be prudent to question the cost-effectiveness of regulatory inspections, as currently practised.
John Sharp
Woodley, Berkshire
Mr JOHN TAYLOR (senior inspector, MCA) replies: We are pleased our article has prompted some debate. This was our intention in addition to providing information. However, we do not wish to add to our opinion already expressed in the article at this stage, but wish to respond to the one factual question raised.
A product-related inspection is one targeted at the production and testing of a specific medicinal product in order to assess specific aspects of compliance related to it, rather than an inspection of GMP systems, which will refer to individual products primarily to exemplify how the system operates.