Preparation and review of Standard Operating Procedures
To review the vendor qualification documents and ensure the compliance in line with the SOP.
Follow up for the vendor Qualification activities.
To review Technology transfer documents.
To ensure that approved vendor list is updated as per the Vendor Qualification SOP
Review and execution Equipment, Utility, and other Qualification activities.
Issuance and review of Batch Production and Control Records, Batch Cleaning Records, formats, Registers, Standard Operating procedures, Analytical Records and other documents.
Review of master and executed batch production control records, Batch cleaning record and analytical documents.
Preparation and review of Quality risk assessment records and maintain the tracking for the same.
Preparation and review of Annual Product Quality Review.
