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
 

1) Change control

2) Assessment of required documentation for CSv system

3) URS

4) FDS 

5) Traceability matrix

6) Design qualification

7) FAT acceptance test

8) IQ/OQ/PQ

9) SOP preparation

10) Validation for CSV system

11) Periodic evaluation

12) Equipment history card

13) System description

14) Handover 

15) Periodic review 

15+ years experience in pharmaceutical CSV / CQV specialist.

Mechanical Engineering