Alexander Sharonov, a Lead Process Engineer at Inspirem Rus, became the head of the Pharmaceutical Engineering Center established on the basis of the Eurasian Academy of Good Practices.
The Pharmaceutical Engineering Center continues the work successfully started by the Engineering and Design Department of the Federal Budget Institution "GILS and NP" of the Ministry of Industry and Trade of Russia.
Leading industry experts, members of the International Society of Pharmaceutical Engineering ISPE, who have extensive experience in managing large projects, design, construction and inspection of pharmaceutical production facilities, are involved in the work of the Center.
The main activities of the Pharmaceutical Engineering Center include:
1. Consulting services in the following areas:
- Design and construction of pharmaceutical and medical device manufacturing facilities, with emphasis on consideration of good practice requirements, feasibility and efficiency of design solutions, and their possible optimization;
- preparation of User Requirement Specifications for process equipment and systems;
- risk management to minimize potential threats to product quality and personnel safety;
- qualification and validation of production facilities, equipment, critical engineering systems;
- assessment of production sites for the purpose of contract manufacturing;
- functional and cost analysis of project solutions, which results in assessment of their feasibility and efficiency, cost analysis, indication of risks and provision of recommendations on their minimization, which is especially important in case of the need to optimize the budget;
2. Qualification of DQ documents in order to:
- verify that all URS requirements are taken into account in design solutions;
- assess the design solutions for compliance with the requirements of GMP rules;
- verify implementation of recommendations on risk mitigation, identified during the risk analysis;
- determine the possibility of realization of subsequent stages of qualification and validation;
- reduce the level of risks for subsequent stages of project implementation (in accordance with the requirements of the risk management system and risk analysis in the validation process).
3. Development of a training program for new employees in the areas of pharmaceutical engineering.
4. Audit of engineering solutions for GMP compliance.
Alexander Sharonov emphasizes how important is the platform for professional communication of pharmaceutical engineering specialists, open exchange of experience and independent expert evaluation of project solutions. "By interacting with each other, expressing our opinion, discussing specific problems and sharing our experience, we can not only improve our qualification, but also raise the level and quality of design solutions", - he states
The Pharmaceutical Engineering Center continues the work successfully started by the Engineering and Design Department of the Federal Budget Institution "GILS and NP" of the Ministry of Industry and Trade of Russia.
Leading industry experts, members of the International Society of Pharmaceutical Engineering ISPE, who have extensive experience in managing large projects, design, construction and inspection of pharmaceutical production facilities, are involved in the work of the Center.
The main activities of the Pharmaceutical Engineering Center include:
1. Consulting services in the following areas:
- Design and construction of pharmaceutical and medical device manufacturing facilities, with emphasis on consideration of good practice requirements, feasibility and efficiency of design solutions, and their possible optimization;
- preparation of User Requirement Specifications for process equipment and systems;
- risk management to minimize potential threats to product quality and personnel safety;
- qualification and validation of production facilities, equipment, critical engineering systems;
- assessment of production sites for the purpose of contract manufacturing;
- functional and cost analysis of project solutions, which results in assessment of their feasibility and efficiency, cost analysis, indication of risks and provision of recommendations on their minimization, which is especially important in case of the need to optimize the budget;
2. Qualification of DQ documents in order to:
- verify that all URS requirements are taken into account in design solutions;
- assess the design solutions for compliance with the requirements of GMP rules;
- verify implementation of recommendations on risk mitigation, identified during the risk analysis;
- determine the possibility of realization of subsequent stages of qualification and validation;
- reduce the level of risks for subsequent stages of project implementation (in accordance with the requirements of the risk management system and risk analysis in the validation process).
3. Development of a training program for new employees in the areas of pharmaceutical engineering.
4. Audit of engineering solutions for GMP compliance.
Alexander Sharonov emphasizes how important is the platform for professional communication of pharmaceutical engineering specialists, open exchange of experience and independent expert evaluation of project solutions. "By interacting with each other, expressing our opinion, discussing specific problems and sharing our experience, we can not only improve our qualification, but also raise the level and quality of design solutions", - he states