GMP compliance audit to intermediates/APIs/excipients/packaging materials and drug products.

GMP compliance projects in Pharmaceutical (oral dosage, injectables) /API plants, based on US FDA, EU, ICH… regulations/guidance GMP Audits to Pharmaceutical, API, Excipients, Primary Packaging Materials and Chemical plants. Root cause finding, establishment of CAPA plan, monitoring the development and implementation of CAPA planPreparation and support FDA and EU GMP regulatory inspectionsInterpretation in FDA, CFDA and EU authorities inspectionsICH Q10 Quality Management Systems assessment and establishmentISO 15378 global compliance in Primary Packaging plants for Pharmaceutical marketsValidation of manufacturing processes and cleaning methodsQualification of process equipments (API/Pharmaceutical Plants)Validation of Utilities (purified water systems, HVAC systems, …)Computer System Validation Training programs: ICH Q7A, regulatory affairs, Risk management, Computer System Validation,…Preparation of Drug Master Files(US,EU)