PNR Pharma performs QP batch certification of clinical supplies for the EU and UK
PNR Pharma can provide an experienced EU/UK QP to perform an assessment of the GMP compliance of your vendors from drug substance through to packaging and labelling of the Investigational Medicinal Product (IMP).
QP audits will be performed where necessary and completed audit reports provided. 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 QP to be onsite during the process.
If required, we can perform an initial gap analysis from review of Quality Management System (QMS) documentation and SOPs prior to the audit.
PNR Pharma has a wide network of QPs with extensive experience in audits, including Advanced Therapeutic Medicinal Products (ATMPs), 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.
A QP declaration is required for EU/UK clinical trials regulatory submissions, to confirm that manufacturing, packaging, and testing processes which take place outside of the EU/UK for Investigational Medicinal Products (IMPs) are GMP compliant. A QP declaration will be provided upon successful audit completion. The QP will work directly with you to provide the QP declaration to meet your submission timeframe.
Following IMP manufacture, our QPs will issue a QP certificate on satisfactory review of the appropriate batch records, including any deviations.
A comprehensive list of required documentation for the Product Specification File (PSF) is provided at project initiation and the QPs work closely with your clinical team to ensure that the systems are in place to meet your clinical timeframes.
All documents provided to support your IMP will be proactively reviewed and the QP will be available to discuss any gaps directly with you.
PNR Pharma offers QP review of the CMC sections of Investigational Medicinal Product Dossiers (IMPDs), ensuring the correct data are included to submit to the EU regulatory authorities to support Clinical Trial Applications (CTAs).