PNR Pharma performs QP batch certification of commercial supplies for the EU and UK.
PNR Pharma can provide an experienced EU/UK QP to evaluate your supply chain and perform an assessment of the GMP compliance of your vendors from drug substance/API through to distribution of the commercial product. 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. The QP can also advise whether there will be a requirement to perform release testing of the product upon importation into the EU or UK.
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 regarding the compliance of the manufacturing of the API to EU/UK GMP is required. A QP declaration of the API will be provided upon successful completion of the audit. The QP will work directly with you to provide the QP declaration to meet your submission timeframe.
EU/UK QP Certification
Batches of commercial medicinal products cannot be released for sale or supply in the EU/UK unless the batch has been certified by a QP named on an EU or UK MIA (Manufacturers/Importers Licence).
A comprehensive list of required documentation to support the commercial certification is provided at project initiation and the QPs work closely with your commercial team to ensure that the systems are in place to meet your timeframes.
All documents provided to support your certification will be proactively reviewed and the QP will be available to discuss any gaps directly with you.
The Common Technical Document (CTD) provides a common format for submitting scientific information when applying for marketing authorisations in the European Union, Japan and the United States. PNR Pharma can provide CMC section review of the CTD to ensure all relevant data are included to support product quality and consistency of manufacture.