Validation

Types of Validation Services

​A. Process Validation

• Pharmaceuticals & Biotechnology

  • Sterilization processes (autoclaves, SIP)

  • Aseptic filling & lyophilization

  • Cleaning validation (CIP/SIP)

• Manufacturing

  • Production line qualification

  • Packaging process validation

B. Equipment & Facility Validation

• IQ/OQ/PQ (Installation/Operational/Performance Qualification)

  • HVAC systems (cleanrooms, ISO standards)

  • Laboratory equipment (HPLC, bioreactors)

  • Industrial machinery (compressors, reactors)

C. Computer System Validation (CSV)

• FDA 21 CFR Part 11 Compliance

• ERP/MES/SCADA System Validation

• Laboratory Information Management Systems (LIMS)

D. Analytical Method Validation

• HPLC, GC, Spectrophotometry

• Microbiological testing

• Stability studies

E. Cleaning Validation

• Residue limits (API, detergents)

• Swab & rinse sampling

• TOC (Total Organic Carbon) analysis

F. Transport & Storage Validation

• Cold chain logistics (2-8°C, -20°C, -70°C)

• Temperature mapping studies

​