Pharmaceutical engineering. Integration, development of common rules and approaches
On September 23, in terms of the IV All-Russian GMP-conference with international participation, a panel discussion will take place, in which quality directors, designers, engineers-technologists, representatives of validation departments and inspectorates will discuss pressing and topical issues of Good Engineering Practice.
Issues of compliance with GMP requirements draws more attention from the pharmaceutical industry in Russia. Since autumn 2018, the industry press began a heated discussion among pharmaceutical companies and design bureaus on how to regulate the process of their interactions, what steps should be taken to minimize the risks of poor quality design and reduce associated costs for customers. This discussion will be continued in the panel discussion «Pharmaceutical engineering. Integration, development of common rules and approaches» at the IV All-Russian GMP-conference.
As Igor Falkovskiy, the Head of the Department for Good Engineering Practice of the State Institute of Drugs and Good Practices (SID&GP) and the moderator of panel discussion notes that taking into account the requests received by the Institute, it was decided to include the following questions into the agenda of the discussion:
- Impact of project quality on pharmaceutical production operation,
- The relationship between engineering and quality in production,
- Integration of Good Engineering Practice into the Quality Management System,
- Engineering for biotech industries.
«Needless to say, that we do take into account the experience of foreign colleagues who were invited to share their best practices of pharmaceutical plant construction management. We also could not avoid the world trends, the brightest of which is Pharma 4.0. Christian Wölbeling, Senior Director Global Accounts at Werum IT Solutions GmbH, will talk about Pharma 4.0 as a way of lean manufacturing, linking digitalization to ICH regulatory guidelines and a holistic approach to implementing the ICH control strategy».
The agenda of the discussion turns out to be outstanding indeed. The presentations from Novo Nordisk A/S will be dedicated to life-cycle approaches to validation of production systems in the GMP environment, changes in new guidelines and regulator expectations, to which pharmaceutical manufacturers should be able to adapt at a faster pace. As many pharmaceutical plants are now expanding their manufacturing capacity, their representatives in particular will state the customers’ position. As quality directors and process engineers often point out, before choosing a contractor capable of meeting all the requirements not only from the economic point of view, but also from the quality of services provided view, it is necessary to form their own Quality Management System in this area of activity and adhere to its principles. In particular, Valery Aristov, Director of Quality Assurance at Pharmasyntez JSC, referring to the design of pharmaceutical manufacturing, will talk about key stages, documents and control points of the project, which affect its compliance with GMP requirements.
The position of the design bureaus and the experience of European colleagues will be presented by Vitaly Hilai, a process engineer at one of the oldest engineering companies in Germany, Bilfinger Tebodin CIS. The history of Bilfinger Tebodin CIS dates back to 1880, when August Bernatz founded his engineering business. Taking into account centuries of experience and current global trends in the field of engineering and process automation, the representative of Bilfinger Tebodin CIS will demonstrate the benefits of using BIM tools (building information modeling or building information model) to improve the quality of pharmaceutical projects. The Russian design bureaus side will be represented by the National Engineering Corporation «NEC».
- Rules for organizing and conducting inspection of pharmaceutical manufacturers for compliance with GMP requirements have been changed
- Pharma is under control
- PIC/S Meetings in Toyama (Japan)
- Russia will be able to join PIC/S and break into new pharmaceutical markets
- Mutual trust is the fundamental principle of building relationships between the EAEU member countries