Melbourn Scientific is one of first UK labs inspected for good manufacturing practice (GMP) under the EU Clinical Trials Directive
Melbourn Scientific is one of the first analytical laboratories to be inspected for GMP under the EU Clinical Trials Directive, which has made the stringent requirements of good manufacturing practice mandatory for all organisations involved in the manufacture and testing of investigational medicinal products.
Steve Westcott, managing director of the Melbourn-based pharmaceutical contract laboratories, believes that inspection by MHRA (Medicines and Healthcare products Regulatory Agency) and the feedback it gives to labs will help to drive up safety and quality standards throughout the industry.
"These inspections differ from those of the FDA as they focus on the quality control within the laboratory and are not restricted to a single project or product.
"So the investigation was far reaching, ranging from the management of the organisation and training of staff right down to the way that samples are logged and stored.
"The inspectors toured the facility, observing procedures and interviewed staff.
"As such it impacted on everyone and it is a credit to all our staff that we passed with flying colours".
Good manufacturing practice (GMP) ensures that a medicinal product is fit for purpose, ie, it is the right product, right strength, free from contamination and has not deteriorated or degraded in any way - all procedures carried out by an analytical laboratory.
Although many labs were already complying with the intent of the directive, and Melbourn has passed four inspections by the FDA, the MHRA inspection did have some unique features.
As Westcott explains: "With the FDA and other inspections, we are generally asked to comment retrospectively on a procedure.
"The MHRA inspection was much more hands-on.
"In order to demonstrate that its systems and procedures are rigorous, labs are asked to analyse samples from diverse sources using methods that could be new to the analysts involved.
"This is something we do regularly for clients but not before under 'test' conditions, it was like a university practical exam".
For other laboratories facing an inspection Westcott recommends that all staff are briefed about the inspection and all key documentation is made readily available and offers the following reassurance: "A good analytical laboratory will already have the requirements of the directive embedded in its culture and if the inspectors have a good knowledge of the industry then it is an opportunity to gain feedback on best practice in the industry."
