28 April 2014 | News | By BioSpectrum Bureau
The GMP certification will allow Lonza to contract manufacture products for use in the United States and Europe
Singapore: Lonza Bioscience Singapore has announced that it has received the Good Manufacturing Practice (GMP) certification from the Singapore Health Sciences Authority (HAS).
The GMP certification will allow Lonza to contract manufacture products for use in the United States and Europe.
The audit/conformity assessment, performed by the HSA, confirmed that Lonza Singapore has maintained an overall acceptable level of compliance with the Pharmaceutical Inspection Convention/Co-Operation Scheme (PIC/S) Guide to Good Manufacturing Practice (GMP) for Medicinal Products (Part I) relating to finished products, reports added.
PIC/S guidelines to GMP for Medicinal Products (Part I) require that the company is compliant with the standards required for quality management, personnel, premises and equipment, documentation, production, quality control, contract manufacturing and analysis, complaints and product recall, and self-inspection.
"We are proud to be one of the first cell therapy contract manufacturers in Singapore to have received this certification," said Mr Michael Cicio, Vice President of Operations.
He added, "This certification will allow Lonza to contract manufacture investigational medicinal products for aseptically prepared cell-therapy products and will facilitate the use of these products in both the United States and Europe."