Services Provided

QC Release

NDA Analytics has been inspected by the UK MHRA for compliance with GMP regulations (EU Directive 91/356/EEC) and is approved as a contract acceptor for Quality Control laboratory services on product licences.

For release of pharmaceutical products to market in the EU, GMP regulations require that the product is tested to demonstrate compliance with specification and authorised for release by a Qualified Person (QP). NDA Analytics can provide both the analytical testing and QP services necessary for batch release.

The new EU Clinical Trials Directive (2001/20/EC) contains a requirement for the application of GMP, and therefore a QP release, to clinical trials materials. The directive has been published and will be enacted and implemented in all relevant EU countries by May 2004, therefore it may be appropriate to consider the implications of this for materials manufactured in the approach to implementation and thereafter.