EU GMP/GDP/GACP Audits and Licensing

In the European Union, the roles of the Qualified Person (QP), Responsible Person (RP), and Person Responsible for Quality (PRQ) in pharmaceutical companies are critical. QPs oversee the production processes, ensuring each batch meets EU standards and verifying the quality and safety of manufactured drugs. RPs ensure that during distribution, pharmaceuticals are stored and transported according to quality standards, maintaining traceability and overseeing recall procedures. PRQs monitor overall quality management systems, continuously checking product compliance with quality standards and managing improvement processes. These professionals are experts in EU laws and regulations governing pharmaceutical trade.

Leveraging the expertise of QPs, RPs, and PRQs allows us to offer comprehensive services to our clients. We ensure production processes meet EU standards, manage the secure and traceable distribution and storage of pharmaceuticals, and establish and enhance quality management systems. Additionally, we provide consultancy for compliance with EU pharmaceutical regulations and offer training on EU standards and regulations. These services ensure that our clients’ pharmaceuticals enter the EU market safely and smoothly, achieving compliance and maintaining high-quality standards.