Amitkumar Naik

I have been dealing with pharmaceutical CSV system , CQV engineer for more than 10+ years and faced all regulatory audits.

Worked extensively Qualification of new and legacy system updation to comply for CSV as per GAMP5

Following are the details of documentation carried out for CSV system

• Change control
• Assessment of required documentation for CSv system
• URS
• FDS
• Traceability matrix
• Design qualification
• FAT acceptance test
• IQ/OQ/PQ
• SOP preparation
• Validation for CSV system
• Periodic evaluation
• Equipment history card
• System description
• Handover
• Periodic review

15+ years experience in pharmaceutical CSV / CQV specialist.

Mechanical Engineering