Intertek ASG Laboratory, Manchester, UK

Intertek ASG Case Study:

Regulatory NMR Analysis Services

GLP NMR, GMP NMR and cGMP NMR

Intertek ASG recently launched GLP and GMP / cGMP NMR services from the laboratory in Manchester. There has been a strong customer response to this service offering, principally from pharmaceutical and fine chemical companies seeking these advanced services from an established laboratory with track record and relevant regulatory accreditations.

The laboratory operates two NMR spectrometers, 300MHz and 500MHz, both qualified to cGMP standards. To meet regulatory requirements hard copy data is provided to customers and copies of the raw data can also be provided electronically or in Bruker file format which could be processed by software such as XWINNMR, ACD, MestReC or NUTS.

GMP NMR services have included studies on small molecules, macromolecules and impurities in these products. Through its team of capable scientific specialists, Intertek ASG is offering in depth knowledge of NMR technology and its application to chemical development while still meeting the regulatory demands of cGMP. Intertek ASG is also able to offer a broader solutions based approach which integrates the NMR service into a much wider range of service offerings to GLP and GMP / cGMP standards.

The dedicated QA team at Intertek ASG is happy to talk through regulatory requirements for these advanced services with clients.