Contact | Print version | PDF version | Send article | RSS-Feed

Pharmaceutical Profiles maintains GMP certification

11 Dec 2007 - Pharmaceutical Profiles has had its Good Manufacturing Practice (GMP) status confirmed. The company is one of only a handful of clinical service providers to hold both GMP and Good Clinical Practice (GCP) certification. 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, shortening Pharmaceutical Profiles clients' development by as much as several months. For early drug development programs, reaching the major milestone of proof of concept in patients may be achieved far faster.
 
Peter Scholes, PhD, Vice President of Pharmaceutical Sciences at Pharmaceutical Profiles, explained: "Our capabilities in formulation development and manufacture are substantial, including intravenous, oral and inhaled formulations. In particular, we have more than 17 years' experience in addressing oral modified release challenges. 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."
 
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.