Role & responsibilities-
- To ensure for cGMP followed by all personnels at non sterile Formulation.
- To approve Standard Operating Procedures pertaining to the Non Sterile Formulation.
- To ensure 21 CFR part 11 compliance to all Instrument, PLCs and computerized system.
- Online review/Audit of laboratory control system in accordance with cGMP/cGLP and standard operating procedure.
- Review and Approved of Stability Summary report.
- Review and approved of Analytical documents.
- Ensure implementation of Data Integrity Review System.
- To ensure Qualification and re-qualification of equipment and instruments, ensure for correctness of the report and approve the qualification reports.
- To ensure CFR part 11 compliance to all instruments, PLC's and computerized system.
- Ensure process validation, Cleaning validation, Analytical method validation and documentation for the same.
📌 Analytical QA Executive/Officer (Ratlam)
🏢 IPCA
📍 Ratlam