Episodes on Quality Assurance: part 2

Rationalization of manufacturing method description

As a result of voluntary recalls due to discrepancies between the approval documents and actual manufacturing conditions, and the resulting suspension of operations, the shortage of pharmaceutical products has been prolonged, and no decisive remedial measures are yet in sight. Under these circumstances, if rationalization of the description of manufacturing methods, i.e., simplification of the description of manufacturing methods with emphasis on "scientific basis" and "impact on quality," were allowed, even a little, it would deter the occurrence of discrepancies between the approval documents and manufacturing records, reduce recalls and suspension of operations, and eventually lead to securing a stable supply. This would reduce recalls and stoppages of operations, which in turn would help to ensure a stable supply. It is also expected to lead to a reduction in work related to change management and pharmaceutical procedures involving changes in approved items.

GMP has two aspects, "regulation and science," and the goal of both is to ensure the quality and stable production of pharmaceutical products, which should not be contradicted.　However, many of the recalls over the past several years have been due to discrepancies between the manufacturing conditions in the approval documents and the actual manufacturing conditions, caused by the accumulation of slight changes in manufacturing conditions at pharmaceutical plants over a long period of time. In this regard, "rationalization of manufacturing method description in the approval document" is considered to be of great importance.

Several measures are currently being considered to ensure a stable supply of pharmaceuticals, especially generics, but streamlining the description of manufacturing methods in the approval documents would be a more fundamental measure.　Although it is not easy to define specific rules for "reasonable description," the basic idea is to allow for slight changes in conditions that tend to occur in actual manufacturing operations, and to make descriptions as simple as possible based on "scientific data and evidence regarding the effects on quality.