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During an open expert-advisory workshop, experts and representatives of the pharmaceutical industry discussed the issues of risk analysis in planning of validation activities in manufacture

At the end of January, FSI «SID & GP» and the Pharmstrategy company held a regular expert-advisory workshop within the joint program of promoting implementation of the best practices in the Russian pharmaceutical industry on the topic “Risk analysis in planning of validation at pharmaceutical manufacture”. The workshop gathered the audience of 40 representatives of the pharmaceutical industry.

According to effective GMP requirements, validation is applied throughout the whole product life cycle, and the decisions in terms of the scope and volume of qualification and validation shall be based on risk assessment. Implementation of an effective validation policy at the facility is able to significantly reduce the risks of non-conformities with GMP requirements and substantially facilitate the procedure of undergoing an inspection by regulatory authorities.

At the expert-advisory workshop on the topic «Risk analysis in planning of validation at pharmaceutical manufacture», the participants worked with real cases – they analyzed the situations from the practice of inspections. Case study is the most effective way to investigate and understand the nature of the topic. In one of the cases, the audience was offered to simulate a real situation at manufacture with involvement of an inspector and a site representative. Each party tried to defend its position using the justification and own evidence. Such a form of presenting the material was enthusiastically welcomed by workshop attendees and resulted in a hot discussion. The audience appreciated the valuable character of consultations and comments given by the General Director of Pharmstrategy, Ltd. and the Methodologist of the joint program of promoting implementation of the best practice in the Russian pharmaceutical industry Mr. Dmitry Sheyman.

The workshop attendees also discussed the strategy of switching to a risk-based approach when implementing GMP in manufacture. They could talk to experts on the hottest topics related to risk assessment, the risk analysis system, the strategy of moving towards a risk-based approach upon GMP implementation. Speakers and experts of the workshop eagerly responded to questions and explained GMP guidelines and non-conformities in terms of validation and risk management.

«For us, being inspectors and regulators, it is very important that a pharmaceutical manufacturer could monitor and control the drug product quality at all steps of its manufacturing cycle», sais the Head of GMP Methodology and Training Programs Department of FSI «SID & GP» Mr. Anton Avramenko. «Risk analysis implemented at a facility demonstrates the comprehensiveness and the degree of understanding the processes executed in manufacture. It is also a tool of quality and validation activities management. That is why during on-site visits and checks, inspectors pay a special attention to the system of risk analysis and management, to execution of deviation logbooks and the structure of validation processes at a facility.»