(Taiwan) ScinoPharm announces SafeBridge Potent Compound Safety Certification :: BiotechEast - Taiwan and China biotechnology, medical devices, pharmaceuticals, ^¤å½s×, ^¤å×§ï ::

(BiotechEast staff)

30 November, 2009
ScinoPharm, an active pharmaceutical ingredients (APIs) manufacturer based in Taiwan announced recently that its Tainan facility had received 'Potent Compound Safety Certification' from SafeBridge Consultants, Inc., a US-based consulting firm servicing the pharmaceutical industries.

The certification confirms ScinoPharm's competency and proficiency in the safe handling of potent active pharmaceutical ingredients (APIs), and applies to specific laboratories and production areas used for the manufacturing and handling of potent compounds, according to the

According to the company, ScinoPharm is the first API manufacturer in Asia to receive this certification, and joins six other facilities in the United States and Europe actively involved in the SafeBridge Potent Compound Safety Certified program to date.

"The certification demonstrates our company's commitment to maintaining international standards. Not only are our plants cGMP certified, our stringent enforcement of environmental, health and safety codes are rarities in Asia," said Dr. Jo Shen, President and CEO of ScinoPharm.

In determining certification, SafeBridge conducted a 60-element review of programs, procedures, containment and control of the active pharmaceutical ingredients at the company's site, including on-site assessment of the potent compound manufacturing and laboratory areas and the associated equipment, training, toxicology and industrial hygiene support. Certification covers facilities, containment equipment, procedures and personnel training concerning potent compound production operations only at ScinoPharm's Tainan facility in Tainan.

ScinoPharm has over twelve FDA approved, independent production lines with separate air handling systems. Some of the lines are reserved for non-cytotoxic (lower potency) compounds. Facilities not destined for handling high potency products were not part of the certification program.

With a cGMP manufacturing facility specifically designed to manufacture cytotoxic and high potency compounds, ScinoPharm can readily handle a range of oncology and hormonal products, as well as most other APIs made of small molecules, peptides and nucleic acids in its other production lines, according to the company.

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