- Lonza’s facility joins leading CMOs as one of the first Cell Therapy manufacturing facilities in Singapore to receive certification from the Singapore Health Sciences Authority (HSA)
- This cGMP Certification demonstrates Lonza’s compliance to cGMPs in the manufacture of clinical cell-therapy products made in Singapore
Basel, Switzerland, 17 April 2014 – Lonza Bioscience Singapore Pte Ltd announced today that they have received cGMP certification from the Singapore Health Sciences Authority (HSA). 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. This encompasses all the recommendations of the World Health Organization (WHO) in relation to GMP.
PIC/S guidelines to GMP for Medicinal Products (Part I) require that the company is 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.
“We are proud to be one of the first Cell Therapy contract manufacturers in Singapore to have received this certification,” said Michael Cicio, Vice President of Operations. “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.”
The Health Sciences Authority (HSA) was formed on 1 April 2001 as a statutory board of the Singapore Ministry of Health with the integration of five specialized agencies: the Centre for Drug Evaluation; Institute of Science and Forensic Medicine; National Pharmaceutical Administration; Product Regulation Department; and Singapore Blood Transfusion Service. Its vision is to be the leading innovative authority protecting and advancing national health and safety.