Projects for Construction of GMP Facilities

INEX designs and delivers turnkey laboratories that fully comply with international GMP requirements and standards.

Understanding the GMP Standard

The international GMP (Good Manufacturing Practice for Medicinal Products) standard is one of the world’s core regulatory frameworks for the production of pharmaceuticals, biopharmaceuticals, veterinary medicines, medical devices, diagnostics, dietary supplements, and even certain food products.

GMP ensures consistent product quality by guaranteeing that:

• The final formulation matches the declared composition;
• No foreign contaminants are present;
• Labeling, packaging, and expiration dates are accurate and reliable.

To meet these requirements, production must take place in certified cleanrooms. In Russia, the national equivalent of GLP is defined by GOST R 53434-2009 (“Principles of Good Laboratory Practice”).

Customized Cleanroom Design for Your Production Needs

INEX designs GMP-compliant cleanrooms tailored to your specific production profile, including:

• Type and volume of output;
• Technological equipment layout;
• Staff capacity;
• Spatial relationships between functional zones;
• Optimal ratios between production areas and engineering support systems.

Materials and Certification Compliance

We use only certified materials and equipment that ensure the completed cleanroom:

• Protects production processes from external environmental influences;
• Maintains the required cleanliness classification throughout operation;
• Meets all regulatory documentation and audit requirements.

Supporting Russia’s GMP Transition

Many Russian pharmaceutical manufacturers face challenges in obtaining GMP certification due to non-compliant or uncertified premises. However, national regulations now mandate that all enterprises supplying medicinal and related products to the domestic market transition to full GMP compliance.

INEX will develop an optimal, cost-effective GMP-compliant cleanroom project for your business—and deliver it on time, to specification, and ready for regulatory inspection.