GMP audit paves way for European trials

Toronto-based buccal drug delivery specialist, Generex Biotechnology recently commissioned a successful audit of its Oral-lyn manufacturing facility.

The audit assessed the facility's compliance to EU Directives relating to GCP and GMP in conducting clinical trials and producing medicinal products for human use.

The independent audit, carried out by UK-based Penn Pharmaceutical Services, was commissioned in anticipation of the company's application to the MHRA in London for a Clinical Trial authorisation for Phase III trials of Oral-lyn, a proprietary oral insulin spray formulation that delivers insulin into the human body by way of the buccal mucosa (i.e. in the mouth with no lung deposition) in a safe, simple, fast, effective and convenient way. Penn also undertook a preliminary review of the draft IMP dossier for Oral-lyn.

'We are pleased to have received such a positive audit report from Penn', said Generex chief operating officer Rose Perri. 'We can now complete our application for European Clinical Trial authorisation for Phase III trials with comfort and confidence.'

Paul Thomas who carried out the audit commented: 'Generex has suitable manufacturing and testing facilities to support the GMP manufacture of Oral-lyn. It's staff are clearly committed to working in a compliant, high quality manner and the company has demonstrated the capability to build a fully functional and cohesive quality management system to support the European trials.'