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Non-terminally Sterilized Injectables Accept FDA PAI

Case Five

Non-terminally Sterilized Injectables Accept FDA PAI

KRB GMP team provided consulting services for a company to prepare and pass FDA inspection for a sterilized formulation. The consulting services included gap analysis, re-validation consulting, personnel training, system optimization and enhancement, technical support during inspection and response support. This product belongs to an FDA key focused drug product, during the audit process the FDA inspector's demonstrates a high level of inspection and strict rectification requirements. Finally this project passed the FDA pre-approval inspection with only one finding, which is also the first sterilized preparation of the client to pass FDA inspection. Meanwhile, this is the third international inspection cooperation between our client and our team.

CASES SHOW

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.

505(b)(2) Lyophilized Microspheres Accept FDA PAI Inspection (“Zero deficiency”)

KRB GMP team provided consulting services for a company's lyophilized microspheres to prepare and pass for FDA pre-approval inspection. The consulting services included gap analysis, hardware renovation guidance, re-validation consulting, personnel training, system optimization and enhancement, and technical support during the inspection. This product has a very complex sterilized management including sterilized lyophilization, sterilized powder dispensing, non-terminal sterilization pre-filled syringe and other technologies. Finally this project pass FDA PAI without deficiency which is also the first Chinese 505(b)(2) sterilized preparation pass FDA inspection.

Lyophilized Formulation Accept EU Inspection

KRB GMP team provided consulting services for a Pharma Group to prepare and pass EU inspection for their lyophilized preparations. The consulting services included gap analysis, hardware renovation consulting, re-validation consulting, personnel training, system optimization and improvement, mock audit, translation and technical support during the inspection, as well as responses guidance. This inspection was carried out by EU inspectors in full compliance with EU GMP Appendix 1, which was also the first time for this client to pass an EU GMP inspection.

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