PNR Pharma has wide network of QPs with extensive experience in audits, including ATMP(s), Biologics, Biotechnology, Sterile Products, solid dosage forms, semi-solids, liquids, drug/device combinations and novel dosage forms. We cover active ingredients, finished dosage form, analytical/microbial testing, and supply chain.
If any significant issues are found during the audit the QPs will work with yourself and the site to remedy any problematic areas, including the option for the EU QP to be onsite during the process.
If required, we can perform an initial GAP analysis from review of QMS documentation and SOPs prior to the audit.
A QP Declaration is required for EU clinical trials regulatory submissions, to confirm that manufacturing, packaging, and testing processes which take place outside of the EU for investigational medicinal products (IMPs) are GMP compliant. A QP declaration will be provided upon successful audit completion. The EU QP will work directly with you to provide the QP declaration to meet your submission timeframe.
EU QP Certification
Following IMP manufacture, our QPs will issue a QP Certificate on satisfactory review of the appropriate batch records, including any deviations.