Lyophilized Formulation Accept PIC/S&TGA Inspection
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Lyophilized Formulation Accept PIC/S&TGA Inspection
KRB GMP team provided consulting services for a Pharma Group to prepare and pass Australian TGA inspection for their lyophilized formulations. The consulting services included gap analysis, hardware renovation guidance, re-validation consulting, personnel training, system upgrading and enhancement, translation and technical support during the inspection, and Response strategies and guidance. This TGA inspection was conducted in full accordance with EU GMP Appendix 1, demonstrating a very rigorous, high standard and regulatory required audit procedure, and finally this customer passed the TGA inspection.
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