This service is offered through our alliance with Quality Context Limited in Sheffield, UK.
Qualified Person (QP) is a technical term used in European Union pharmaceutical regulation (Directive 2001/83/EC for Medicinal products for human use). The regulations specify that no batch of medicinal product can be released for sale or supply prior to certification by a QP that the batch is in accordance with the relevant requirements. The requirement for QP oversight has been extended to material for use in clinical trials since the introduction of EU Directive 2001/20/EC. In countries that are part of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S), the same role may be termed Responsible Person (RP) or Authorized Person (AP).
Our expert QP consultants has several years experience working in pharmaceutical manufacturing operations. This experience includes:
- Auditing API manufacturers and medicinal product manufacturers to Eudralex Volume 4 and 21 CFR 210 and 211 and excipient manufacturers to IPEC guidelines.
- API process development, scale up and technology transfer, particle size and polymorph control.
- Excipient-API and excipient-excipient interaction and dosage-form development.
Our team of expert pharmaceutical consultants can provide much needed support to enable dossier submission, regulatory approval and the successful release of marketed products around the world.
PDS offers an indenpendent third-party auditing service for QPs to meet their legal obligations under article 46(f) of Directive 2001/83/EC (and amendments) and Guidance Document EMEA/INS/GMP/313538/2006 and Article 50(f) of Directive 2001/82/EC (and amendments). With API supplies coming from many different companies in various locations in the world, this is a huge burden on limited resources of time and personnel; PDS can help to reduce this burden.
The auditors are fully conversant with GMP requirements for APIs and medicinal products in the Regulated Markets and have considerable experience in auditing suppliers to the pharmaceutical industry.
PDS can offer a contract service to undertake all your auditing requirements.