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Assessment and Revision of Existing Project to Comply with National and European GDP Standards

An assessment of the existing project was prepared for the client and revised to meet 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)

  • Technical and Functional Specifications (DS & FS)

  • Risk Analysis/Checklists (RA)

  • Validation Master Plan (VMP)

  • Qualification/Evaluation of Warehouse Layout and Engineering Systems (DQ)

  • Installation Qualification/Verification (IQ)

  • 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

  • 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).

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