Successful MHRA inspection of Almac’s clinical services U.K. facility

Wednesday, September 26, 2012 11:18 AM

Global service provider Almac passed a successful inspection of its clinical services operations located in Craigavon by the U.K. Medicines and Healthcare products Regulatory Agency (MHRA).

The inspection, which occurred from Sept. 17 to 20, 2012, was a routine inspection conducted by a MHRA inspector from the regulatory body who concluded that the site continues to be compliant with E.U. Good Manufacturing Practices, with no critical or major failures observed.

“Once again we are extremely pleased with the outcome of our inspection,” said Paul O’Connor, vice president of quality. “Quality is at the forefront of all our operations and all our employees continuously strive to ensure we have all the necessary processes in place to support our reputation in delivering global regulatory compliance and quality management excellence.”

O’Conner continued, “This latest inspection is even more significant as it comes at an exciting time as we prepare to implement our new multi-million pound ERP system. This was reviewed intensively—one and a half days in total during the inspection period and resulted in no findings—testimony to our confidence that this exciting new development will further enhance our position as the premium supplier of global clinical supply chain solutions to the pharmaceutical and biotech industries.”

Almac has three MHRA approved clinical services facilities globally, including its additional FDA-assessed U.S. facilities in Souderton, Penn., and Durham, N.C.

Share:          
CWWeekly

April 13

Quintiles-Quest Diagnostics joint venture latest in CRO-central lab deals, more could be on horizon

Biotech companies raise record amount of capital in Q1

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

April

PSI, INC Research, Chiltern best with sites
Strategic outsourcing prioritizing, improving site relationships

Regulatory compliance an increasing burden on sites
Increased staff time, materials, storage eroding site operating profit

Already a subscriber?
Log in to your digital subscription.

Purchase the March issue.

Subscribe to
The CenterWatch Monthly.

The CenterWatch Monthly

March

Novo Nordisk, Takeda, Servier, Celgene among top sponsors
New gains seen from patient- and site-centric initiatives

Patient reported outcomes take center stage
FDA combining PROs, clinical outcomes in its approval decisions

Already a subscriber?
Log in to your digital subscription.

Purchase the February issue.

Subscribe to
The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs