Lonza obtains HSA GMP certification for its Singapore facility

Lonza Bioscience Singapore Pte Ltd announced that it has received cGMP certification from the Singapore Health Sciences Authority (HSA). The audits conducted 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. It covers all the recommendations of the World Health Organization (WHO) in relation to GMP.

PIC/S guidelines to GMP for Medicinal Products (Part I) demands that the company should be compliant with the standards required for the following: quality management, personnel, premises and equipment, documentation, production, quality control, contract manufacturing and analysis, complaints and product recall, and self-inspection.

Lonza is one of the world’s leading and most-trusted suppliers to the pharmaceutical, biotech and specialty ingredients markets. Lonza also offers services and products ranging from active pharmaceutical ingredients and stem-cell therapies to drinking water sanitizers, from the vitamin B compounds and organic personal care ingredients to agricultural products, and from industrial preservatives to microbial control solutions that combat dangerous viruses, bacteria and other pathogens.

Company’s spokesperson said that they are proud to be one of the first Cell Therapy contract manufacturers in Singapore to receive this certification. 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.