Implementation of Compendial/Pharmacopeia Test Procedures

One of the major challenges with implementing pharmacopeia procedures is they are accepted for publication based on validation data for a particular formulation or synthetic route of a drug product or drug substance. Because of this, problems are often incurred when trying to implement them. A further challenge with the traditional verification process is that there is limited guidance for acceptance criteria for important data quality attributes such as accuracy and precision. This chapter proposes an approach to overcome common problems by integrating the traditional verification process with the lifecycle approach. Use of the following key lifecycle principles include : assessment of selected analytical procedure performance characteristics (APPCs); Knowledge gathering; the Analytical Target Profile (ATP); the Analytical Control Strategy (ACS), performance qualification and monitoring the method in in routine use. This integrated approach leads to successful implementation and leads to fewer failures occurring when a procedure is used routinely.