Lyophilized Formulation Accept EU Inspection
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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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