Melbourn Scientific says it has passed its most recent US Food and Drugs Administration inspection with flying colours, confirming the contract research organisation's international status
Melbourn Scientific is based in the Melbourn Science Park near Royston, UK, and was established 15 years ago to provide contract analytical services for the pharmaceutical business.
The laboratory plays an important role in ensuring that tablets, inhalers, creams and capsules all perform as they should.
The FDA initiated the investigation following a stability study performed by the laboratory for a new tablet that must meet the stringent requirements of the international community.
The FDA inspection was exhaustive and can be seen as a seal of approval for the quality procedures at Melbourn Scientific, says the company.
The official report commented that "no significant deficiencies were noted and no 483s were issued".
Founder and managing director of Melbourn Scientific, Steve Westcott, has implemented a unique parallel process quality procedure in the laboratory and believes this was a key element in the company's success.
"When taking a new medication from research through to manufacture, the methods used to develop the product must be reproducible.
"Regulatory bodies such as the FDA need evidence of this.
"Our analysts work closely with client organisations to understand and then replicate their methods in the laboratory.
"Running alongside this is a separate quality control team.
"Crosschecking at all stages ensures that any issues are picked up immediately and that the method is sound and there are no delays or loss of samples.
"The additional benefit of this process to the client is that the documentation can be used as evidence that the methodology can be successfully reproduced".
Melbourn Scientific has invested continually in the latest equipment.
Recent additions have been introduced to broaden its range of stability and photostability storage cabinets, which maintain constant temperature, humidity and light conditions.
These will allow the company to assess the shelf life of tablets or other medicines over several years.
The company employs about 40 analysts at its laboratories and has grown organically to provide a range of contract analytical services to the pharmaceutical industry.
