The Bulgarian Drug Agency (BDA) announced that they will initiate the procedure …
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Quality Assurance
We partner with highly qualified professionals experienced in providing quality management auditing and consultancy services in the pharmaceutical field.
Qualified Person and Quality Expert Services
Our QPs and Quality Experts provide the following services, in accordance with the EU Good Manufacturing Practice (GMP) for medicinal products:
– Complaints handling;
– Product Quality Reviews (PQRs);
– Quality Management System implementation and update;
– EU Batch certification and product release;
– Technical / Quality Agreements;
– Host for regulatory and customer audits, GMP/GDP inspections;
– Self-Inspections;
– Mock recall test.
GMP and GDP Auditing Services
Our experts audit pharmaceutical manufacturing facilities and warehouses according to the EU Good Manufacturing and Good Distribution Practices. Our auditors create, maintain and track audit schedules and they plan and lead the audits. Audit reports are issued and the auditors track observations through CAPA and perform audit closure.
– Pre-inspection gap analysis audits;
– GMP/GDP audits (internal or at the suppliers).