Pharmaceutical Profiles maintains GMP certification

Published: 14-Dec-2007
Sustainability Regulatory

UK-based Pharmaceutical Profiles, is one of only a handful of clinical service providers to hold both Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) certification, has had its GMP status confirmed.

UK-based Pharmaceutical Profiles, is one of only a handful of clinical service providers to hold both Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) certification, has had its GMP status confirmed.

As a result, drug formulations can be manufactured on-site for use in clinical trials. Importantly, this enables formulation stability testing time to be significantly reduced, and reaching the major milestone of proof of concept in patients may be achieved far faster.

Awarded by the Medicines and Healthcare products Regulatory Agency (MHRA), GMP certification is provided on a biennial basis following a detailed inspection of the manufacturing site and its quality systems. This was the second of such inspections at Pharmaceutical Profiles since the implementation of the clinical trial directive (2001/20/EC) into the UK in 2004.

"This continued GMP capability gives us the flexibility to provide solutions to any issues uncovered during our studies, such as problems with solubility, half-life or absorption," said Dr Peter Scholes, vice president of pharmaceutical sciences at the Nottingham-based company.

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