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.