AddressReview of Raw Material/Packaging Material /Stability/ Microbiology/ Cleaning Method Validation/ Validation/ Finished Product Analytical data, Certificate of Analysis & related documents.
- Review and approval of Exhibit Stability Protocols.
- Preparation and review of validation /pre-validation /commercial/annual addition batch/thermal excursion/additional study stability protocol.
- Approval of additional testing requests (if required).
- Review and approval of ln-Vitro/CU and dissolution sheets.
- Review and approval of Analytical Method Transfer documents.
- Participation in handling OOS, OOT, Investigation and deviations related to
Quality Control.
- Review and approval of weekly and monthly software verification reports of
Empower3.
- Periodic verification of application software on computer systems, associated with laboratory instruments with system administrator.
- Review of lab instruments calibration/preventive maintenance data.
- Review of Stability test results in NOVATEK software.
- Approval of Certificate of Analysis.
- Review and submission of analytical data to site regulatory affairs.
- To provide the response of regulatory affairs and Office of data reliability queries.
- Review and approval of change control request, specification, standard test procedure and SOP in Documentum Compliance Manager System.
