Analytical & Instructive Documentation

  • Standard Operating Procedures with abstemious blend of local practices and PQS requirements
  • Guiding Documents and Work Instructions, in compliance to global guidance like ICH, USP, EDQM, AOAC, ISO, NIST etc.
  • Computerized System Validation: IQ/ OQ/PQ/ Validation protocols, specifications and reports, ER-ES compliance assessment, Risk assessments, Data Integrity Assessments, Trace matrixing etc.
  • Analytical test method validation and reports
  • Drug product and API specifications
  • Standard test procedures
  • Stability trending
  • Elemental impurity assessment reports in compliance to ICH Q3D and USP <232> and <233>
  • Genotoxic impurity assessment reports as per ICH M7
  • Nitrosamine impurity assessment reports
  • Change management
  • Investigation protocols and reports
  • Corrective and preventive action management