(2003; 148 pages)
9.1 Risk analysis in quality control and impurities
The Committee noted that, even though there was an increasing shift to more sophisticated methods and more stringent test limits internationally, no scientific data were available that demonstrated that the safety of patients was thereby increased. It was therefore recommended that specifications published to date in The International Pharmacopoeia should be maintained and the currently used approach retained. The monographs published in The International Pharmacopoeia can thus be retained - subject to the normal revision process - especially as the majority of monographs concern well known essential drugs proved to be safe over a long period of time.
For new monographs, it was important to define a level of impurities consistent with those in other official standards or pharmacopoeias. The fact that different pharmacopoeias may provide different specifications for varying impurities profiles for the same product must also be considered. If available, harmonized monographs should be preferred.
The recently adopted approach to include - in newly developed monographs - alternative test specifications should also be maintained. The policy is to introduce less technically demanding analytical procedures as alternatives when more sophisticated methods are described in the monograph (Annex 2).