Construction of a Prefabricated Modular Building for a Thermal Disinfection and Decontamination Station for Pathogenicity Groups III–IV Effluents

In early November 2023, INEX management signed an agreement with the Saint Petersburg State Chemical and Pharmaceutical University (SPCPU) of the Ministry of Health of the Russian Federation to provide an advanced professional training program for company employees. The specialists from the "Project Consult" division (part of the INEX group) are enrolled in the specialized course: "Production of Sterile Medicinal Products in Accordance with GMP Rules."

This educational program is designed to strengthen and expand expertise in pharmaceutical quality assurance, as well as the fundamental principles of Good Manufacturing Practice (GMP). The curriculum provides deep insights into the rigorous standards required for aseptic processing and sterile manufacturing environments.

The Training Process Includes:

• Distance Learning: Interactive lectures covering global and national GMP standards.

• Practical Assignments: Solving technical tasks and case studies related to sterile production challenges.

• Testing: Mid-course assessments to verify the comprehension of complex regulatory requirements.

• Final Certification: A comprehensive final examination to validate the acquired knowledge and skills.

To offer our clients the most advanced engineering and consulting solutions, it is essential to stay aligned with scientific developments and innovative technologies. Continuous professional development is a cornerstone of the INEX strategy, ensuring that our team provides the highest level of professional cooperation and expertise in the biopharmaceutical industry.

Regulatory and Standards Framework The training is aligned with current international and national regulations, including:

• EAEU Good Manufacturing Practice (GMP): (EEC Decision No. 77) — specifically regarding Annex 1: Manufacture of Sterile Medicinal Products.

• Order of the Ministry of Industry and Trade No. 916: National standards for the organization of pharmaceutical manufacturing.

• ISO 14644: Standards for cleanroom classification and environmental control.