Prakash M.

ABOUT ME

• Review of SOP, Specification, COA, Method validation, Process validation, BMR, BPR & stability data and other related documents.
• Preparation of Risk assessment reports.
• Review of SMF & GMP related Documents.
• CAPA of Audit Report & its track maintains for compliance if any.
• Facing local FDA audit & customer audits.
• Review of all QMS documents related to facility & departments.
Regulatory
• Compilation of Open & Closed part DMF in eCTD format.
• Compliance of queries raised by customer.
LICENCE:
• Application of License like CDSCO, renewal of GMP certificate & Additional product permission on fdamfg website of local FDA.
• Application of Test License, Neutral Code & Addition and deletion of Technical Personnel in Fdamfg website.
• Sugam Portal working.

SKILLS