GxP COMPLIANCE
The pharmaceutical industry is a highly regulated environment and is a subject of guidelines on Good Manufacturing/Distribution/Pharmacovigilance Practises (GMP, GDP, GVP). Compliance with these standards is the purpose of each inspection for which the company need to be prepared. I provide expertise on the company´s Quality Management System (QMS) and get the company ready for such an inspection.
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GxP
Audit of QMS system
Creation of QMS system
Qualified Person (QP)
I perform an internal audit of the documentation (Company policies, Standard operating procedures, Working Instructions...etc.) with the aim to verify established processes.
I help companies to establish an efficient quality management system (QMS). Propose and prepare a robust system of SOPs in accordance with the latest requirements.
I am qualified for the role of Qualified Person (QP) as per Directive 2001/83/EC and take responsibility to release a batch to the distribution.