Evaluation of New Risk-based Regulatory Approach to Classification of GMP Deficiencies (Review)

Abstract

Introduction. This paper is devoted to analysis of a new risk-based regulatory approach to the classification of deficiencies found by inspections of medicines manufacturers, which is undoubtedly relevant.Text. The article describes the new definitions for the deficiencies found in the medicinal products manufacturing, the proposed gradation of non-conformances distinguishes from the one that is currently used. The proposed innovation in regulatory activity is that a critical deficiency can consist of several related nonconformities, none of which can be critical on their own, but which together can constitute a critical nonconformity or system failure. The proposed approach to the classification of deficiencies, which is based on a risk assessment for the patient, is described. The main stages of the risk-based algorithm are characterized: a detailed assessment of the deficiency for its preliminary classification; assessment of risk increase or decrease factors, regardless of the initial classification; making a decision on the final classification, taking into account the factors of increasing, reducing risk or their absence. Block diagrams and illustrative examples are described, on the basis of which preliminary assignment of a revealed deficiency of one or another level of criticality is carried out. The factors of increasing or decreasing risk are considered. These factors are extrapolated to the category of deficiency and they can both increase the preliminary assigned category or decrease it, and can leave the preliminary classification unchanged.Conclusion. A new risk-oriented regulatory approach to the classification of non-conformances with the requirements of Good Manufacturing Practice, proposed by the Pharmaceutical Inspection Co-operation Scheme PIC / S, is described. An analysis of this approach and its characterization are made. The new approach is based on the systematic and methodological application of risk management tools, aimed at justifiably assigning a certain criticality category to a revealed deficiency. The implementation of the new approach allows to increase the objectivity and transparency of inspection procedures. Further detailed study and possible step-by-step implementation of this new approach is very important for regulators so for medicines manufacturers.

Keywords

• надлежащая производственная практика
• инспектирование производителей лекарственных средств
• классификация несоответствий
• риск-ориентированный регуляторный подход