PNR Pharma supports companies with audits and remediation to ensure regulatory compliance of manufacturing processes for both clinical and commercial products.
PNR Pharma offers gap analysis of Quality Management Systems, providing a comprehensive report citing the sections of GMP that the site is deficient in and offering suggestions for appropriate CAPA. The gap analysis report will be prioritised so the most critical or urgent remedial work can be completed first. PNR Pharma will review the CAPA plan generated by the site, provide feedback and work with the client to ensure appropriate systems are in place.
Audits to confirm GMP compliance
PNR Pharma has 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 can perform an initial gap analysis from review of QMS documentation and SOPs prior to the audit. If any significant issues are found during an 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 manufacturing/packaging process.
If any significant issues are found during a Regulatory Agency site audit our QPs will work with yourself and the site to remedy any processes which are out of compliance. If required, the QP can be on site to advise during the remediation process.
MHRA compliance monitor programme
Members of our team have been deemed eligible by the MHRA to act as Compliance Monitors (CMs) in MHRA’s pilot compliance monitor programme for GMP and GDP remediation supervision activities.
The Marketing Authorisation Holder of a commercial product within the EU will need a Wholesale Distribution Authorisation (WDA) to supply product within these regions. PNR Pharma can support set up and management of a Quality Management System (QMS) required for a WDA, and assist with applications for WDA licences.
In order to comply with EU and UK Good Distribution Practice (GDP) Guidelines a wholesale dealer has to appoint a Responsible Person (RP) to oversee the distribution of marketed products, ensuring compliance with the Wholesale Dealers Authorisation (WDA). PNR Pharma can provide an RP who will be responsible for ensuring that the quality management system is implemented and maintained, the accuracy of distribution related quality records, and there is adequate training of staff. The RP will deal with customer complaints and the final disposition of returned, rejected, recalled or falsified products.