One of the Largest Pharmaceutical Warehouses in Georgia

An evaluation of the existing project was prepared for the client, and it was revised to meet national and European GDP (Good Distribution Practice) standards. After the completion of the renovation work, the following validation activities were conducted:

• User Requirement Specification (URS): Development of this document, which should be finalized before the start of the design phase.

• Technical and Functional Specifications (DS & FS): Preparation of detailed specifications for the project.

• Risk Analysis/Checklists (RA): Risk assessment and creation of checklists.

• Validation Master Plan (VMP): Overall validation planning.

• Qualification/Evaluation of Warehouse Layout and Engineering Systems (DQ): Assessment of the layout and engineering systems.

• Installation Qualification/Verification (IQ): Verification of the installation of warehouse and engineering systems.

• Operational Qualification Mapping (OQ): Measurement and qualification of warehouse and engineering systems functionality in an empty warehouse, without products.

• Performance Qualification Mapping (PQ): Testing of warehouse and engineering systems under operational conditions, considering products and seasonal variations (winter/summer).

• Summary Validation Reports: Comprehensive reports summarizing the validation process.

• Project Management: Overseeing the entire project.

• Staff Training: Training for personnel involved.

• Transport Equipment OQ Mapping: Qualification of transport equipment in an empty state, without products.

• Transport Equipment PQ Mapping: Qualification of transport equipment considering products and seasonal variations (winter/summer).

The warehouse was equipped with a continuous temperature and relative humidity monitoring system from the Czech brand Comet.