Qualified Person (QP) Services
European Union pharmaceutical regulation (Directive 2001/83/EC for Medicinal products for human use) specifies that no batch of medicinal product can be released for sale or supply prior to certification by a Qualified Person (QP) that the batch is in accordance with the relevant requirements.
At Source BioScience, each of our expert QP consultants has considerable experience in pharmaceutical manufacturing operations. This experience includes auditing of API manufacturers and medicinal product manufacturers to Eudralex Volume 4 and 21 CFR 210 and 211, as well as standard batch release requirements.
Source BioScience has access to a team of expert pharmaceutical consultants who can provide much needed support to enable dossier submission, regulatory approval and the successful release of marketed products around the world.
Our QP consultants are fully conversant with current GMP requirements for APIs and medicinal products in regulated markets and have extensive experience in auditing suppliers to the pharmaceutical industry.
Source BioScience can offer a contract service to undertake all your auditing or QP requirements.
For further information and prices please contact us or call +44 (0)115 973 9012