Department Details

Role Summary

Review of analytical data pertaining to various testing of materials (Raw materials/Intermediates/Semi Finished Goods/Finished Goods)
Review & approval of specifications, MoA, ODS, standard Operating Procedures & Instrument Operating Procedures; Method validation /verification/ qualification & method transfer activities/process & cleaning validation; working standard, certified standard & impurity standard Qualifications & COAs; floating formats; Dispatch COA, Pre-shipment & Typical Certificate Of Analysis.; certificate of conformance; Specification in LIMS software; SOP/IOP in DMS software; area/ instrument qualification /re-qualification document/mapping activities; IUT; warehouse discrepancies notes.
Issuance, reconciliation; retrieval & archival activities
Preparation, Review & Approval of Stability sampling plan, stability planner & protocol.
Stability study protocol, registration, ...