Project Experience

Sample Projects

Project: Solid Dosage Milling System
Client: Multinational Pharmaceutical Company

Project Summary

ProsCon Ltd. were responsible for Construction Management, Installation, Commissioning and Validation of solid dosage milling system.

The process is an automated production process for processing nano-milled products in accordance with FDA regulations and EU-directives. The process is controlled and monitored by PLC’s, and Scada systems.

The system consists of 3 modules for which were responsible for:

• Validation Documentation and Protocol Execution
  • ProsCon was involved in the document review cycle and was responsible for the execution of all test scripts. A complete suite of validation documentation was prepared for each module and an additional suite for the data collection system
  • In addition to the execution of the validation, a ProsCon representative worked with the US based Engineering Company in debugging the software and implement changes through change control

• Main overall Responsibilities:
  • Act as on-site representative and were responsible for the design and implementation of this project
  • Review validation documentation
  • Oversee installation
  • Execute IQ
  • Execute OQ
  • Prepare Validation Summary Report
  • Test changes resulting from change controls
  • Update Design documents with changes resulting from change controls