Project Experience

Some recent examples of successful projects delivered by the Rx GLOBAL Team:

• Validation Planning
  • Revision of site validation master plan to provide process efficiencies, reflect the current site practices and increased compliance to current industry best practices.
• Regulatory Compliance Auditing
  • cGMP compliance audit of 7 drug contract manufacturing facilities and 1 drug contract distribution centre in North and South America. These included the audit of OTC and prescription liquid, tablet and soft gelatin capsule drug dosage forms to FDA and EU regulatory standards.
• Commissioning and Qualification
  • Creation, review, execution and summary of commissioning and qualification documentation for bottle, bag in box and pouch liquid filling and packaging lines. C & Q of multiple mix tanks, hold tanks and supply lines including associated automation control programs and equipment
• Process Validation
  • Creation, review, execution and summary of process validation documentation for bottle, bag in box and pouch liquid filling and packaging lines.
• Computer System Validation
  • Assisted a North America based team in the validation of a customer complaints & ADE reporting database application.
• Cleaning Validation
  • Assessment and generation of cleaning evaluation/equivalency reports for liquid filling process equipment.
• Technical Writing
  • Review and revision of SOPs for multiple operational units across multiple plant sites. Provided document standardization and process efficiencies for large drug manufacturing and laboratory operation.
• QC Laboratory Specialist
  • Laboratory method development, refinement and troubleshooting for the testing of raw material and finished drug products.
• Project Management
  • Provided a seasoned project engineer to manage and coordinate multiple validation projects involving the installation of new process equipment, piping and multiple filling lines to significantly increase site manufacturing capacity.