GMP Conference 2023: Scientific Approach as the Focus of Experts and Manufacturers 

On September 28 at 10:00, a panel session titled “Science-Based Approach to Pharmaceutical Manufacturing” will be held as part of the GMP Conference.

The session will be moderated by Ms. Madina Sottaeva who is the Head of the Pharmaceutical Manufacturing Inspections Directorate of the Federal State Institution “SID and GP” of the Ministry of Industry and Trade of the Russian Federation and the Chairman of the Expert Council of the Eurasian Academy of Good Practices (EAGP).

The scientific approach is one of the GMP principles that allows to manage product quality throughout all life cycle stages. Provided there is a scientific justification, quality reviews can be grouped by product type (solid, liquid, sterile, etc.), quality risks can be managed, which ultimately relates to patient safety.

Some areas of focus in this area include quality control issues, such as microbiological environmental monitoring and toxicological assessment to confirm the possibility to produce multiple products on the same line.

Each company independently develops its own algorithms of how to assess compliance of the manufacturing facility with the requirements of Good Practices. When establishing the control strategy, it is necessary to consider a lot of parameters using risk analysis techniques.

The Qualified Person belongs to key personnel of the facility and should ensure that each batch has been manufactured and tested in accordance with the current regulatory requirements for the manufacture of medicinal products in accordance with the registration dossier data.

The event will present the interim results of the activities by special working groups within the EAGP Expert Council, which include representatives of regulatory authorities and inspectorates of all EAEU member states. One of the tasks of these working groups is to draft recommendations or guidelines for expanding the GMP requirements. The application of these recommendations will significantly facilitate the establishment of relevant processes at pharmaceutical facilities.

Another task is to ensure the relevance of the GMP guidelines, and we are also working on that. At this session, the draft Annex 1 “Requirements for Manufacture of Sterile Medicinal Products” will also be discussed. Annex 1 is intended to assist national authorities in applying the EU legislation. The guideline has been revised to reflect changes in the regulatory and manufacturing framework. The global pharmaceutical community is now aimed at implementing the updated requirements. Explanations on this matter will be given by representatives of the Expert Council.

Learn more about the program topics and register for the event at:

GMP Conference general partner:

Binnopharm Group LLC.

GMP Conference partners:

Medsintez Plant LLC, SKOPINPHARM LLC, The Pharmasyntez Group of Companies, Valenta Pharm.

Special partners:


Session partners:

WERTEX, Pharmeco Group, Nacimbio JSC, SUN Pharma, PRO.MED.CS Praha a. s.


Please, address questions about participation to:

S-GROUP Corporate Communications Center

+7 (495) 120-53-33

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