Ensure compliance to cGMP for all operational activities.
Initiation, evaluation and review of Deviations, change control and Investigations.
Provide appropriate training and development to support staff to meet their respective job responsibilities.
Owing review and approval of technology transfer documents & ensure smooth transfer of technology development process
Review & approval of SOPs.
Conduct review and approval of Formulation order & manufacturing instruction.
Conduct review and approval of Packaging order & packing instructions.
Conduct review and approval of scale up, test batch monitoring protocol & report.
Conduct review and approval of In-Process Hold Time Study and process validation
Conduct review and approval of master label for Exhibit batches and commercial batches through label printing module system and Artwork management system.
Maintenance of master documents.
Preparation, review and approval of transport validation protocol and report.