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.”
About HSA
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.
About Lonza
Lonza is one of the world’s leading and most-trusted suppliers to the pharmaceutical, biotech and specialty ingredients markets. We harness science and technology to create products that support safer and healthier living and that enhance the overall quality of life.
Not only are we a custom manufacturer and developer, 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.
Founded in 1897 in the Swiss Alps, Lonza today is a well-respected global company with more than 40 major manufacturing and R&D facilities and approximately 10,000 employees worldwide. The company generated sales of about CHF 3.6 billion in 2013 and is organized into two market-focused segments: Pharma&Biotech and Specialty Ingredients. Lonza’s stock is publicly traded on the Swiss and the Singapore stock exchanges. Further information can be found at www.lonza.com.
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