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Main  >  News  >  Workshop on risk-based approach in the study of stability for drugs and APIs

Workshop on risk-based approach in the study of stability for drugs and APIs

On April 18-19, 2019, FBI GILS and NP and PHARMSTRATEGIA LLC, as part of a joint program to promote the implementation of best practices in the Russian pharmaceutical industry, held an open expert consultation on the topic: “Application of a risk-based approach to the study of stability drugs and APS in the light of recent changes in regulatory documentation.”

The development of pharmaceutical technologies makes it possible to make improvements in the production process of already registered drugs. However, it should be remembered that the changes themselves can be a source of serious risks for the quality of the drug, including the fact that they can adversely affect the stability of the drug during the entire shelf life. Such risks are relevant for each manufacturer and are the focus of attention in regulatory inspections.

The GMP rules establish requirements for the development of a program for the subsequent study of stability, which will identify problems with the stability of the drug, as well as for monitoring the stability of a drug of a certain composition in the consumer packaging used.

The purpose of the program for the subsequent study of stability is to confirm that the drug during its entire shelf life meets its specifications subject to the storage conditions specified in the labeling. At the same time, the regulator expects the manufacturer to develop and implement special requirements for the study of stability, based on a risk analysis and taking into account the specific production of each specific drug.

• The seminar examined current regulatory requirements and international recommendations, as well as trends in regulatory documentation for the study of the stability of drugs (methods, equipment, documents), the application of a risk-based approach to solving the problems of the pharmaceutical quality system.
• Particular attention was paid to the practical analysis of the most common inconsistencies identified during regulatory GMP inspections in relation to drug stability.
• The expectations of the Russian inspectorate regarding the requirements for the study of the stability of drugs and pharmaceutical substances during the transition to the GMP Rules as amended by the Decision of the EEC Council dated 10.06.2018 N 69 were presented.

 

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