We made Tablet, Capsule, Syrup, Ointment , Dry injection, Liquid injection sections with the help of HVAC system with BMS system(AHU, LAF ‘s & RLAF ‘S ), water system, utilities and facilities.
Qualification and Validations expertise:
- Qualification and validation of system, facility, equipment, instrument as per VMP.
Hardware and software qualification and validation as per CSVMP, GXP compliances with respect to GAMP 5, 21 CFR Part 11
and EU GMP Annex-11.
- Validation of HVAC system with BMS system and LAF & RLAF, Isolator.
- Aseptic Process Simulation (Media Fill) and Sterilization process validation for SVP and LVP
- Validation of Raw water, potable water, Purified water system WFI system & PSG system.
- Validation of steam sterilizer/Dry heat sterilization & De-pyrogenation and SIP & Steam quality testing
- Containment study w.r.t. Environment Health& Products contamination & cross contamination,
- Cleaning validation of products by matrixing with worst case product identification and equipment chain
- Hold time study for product, material, equipments, Utility system etc.