Proficiency

Our team have vast knowledge built on decades of experience in the areas of Process Performance Qualification, Packaging Validation, CPV, Cleaning Validation, Environmental Monitoring, Audits, Inspections and Quality Assurance as a whole from receiving to shipping and from API to Finished Goods.

Quality and Compliance

synoptex consulting

  • SOPs, GSOPs, WIs and EMs documentation evaluation and/or establishment 
  • Support adherence to regulatory expectations for different markets and countries.
  • Establishment of PPQ program
  • Establishment of Packaging Validation Program
  • Establishment of Cleaning Validation Program
  • Establishment of CPV Program
  • Establishment of sampling plans using Statistical Analysis methodologies.
  • Performing stability and IPC trends using Statistical Analysis methodologies
  • Establishment and implementation of regulatory inspection preparation program.