Assessment and Revision of Existing Project to Meet National and European GDP Standards

An assessment of the existing project was prepared for the client and revised to comply with national and European GDP (Good Distribution Practice) standards. Following 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): Comprehensive 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.

A continuous temperature and relative humidity monitoring system from the Czech brand Comet was installed in the warehouse.