The Food and Drug Administration under the ROC Department of Health unveiled the Pharmaceutical Inspection Convention and Co-operation Scheme, or PIC/S, Good Manufacturing Practice standards logo for the country’s pharmaceuticals July 18 in Taipei City.
“Drug quality and public safety has always been a focus of concern,” a DOH official said at the opening of the Bio Taiwan 2013 biotechnology exhibition in Taipei World Trade Center Nangang Exhibition Hall. “In 1982, Taiwan mandated drug manufacturers to comply with GMP, and quality improvements of local pharmaceuticals have kept pace with advances in international standards.”
In 1995, revised guidelines known as current GMP were adopted, and in 2010, the country began to apply the standards of the PIC/S, to which it was admitted Jan. 1 this year, the official said. The DOH expects all local manufacturers to be fully compliant with PIC/S GMP by the end of 2014.
PIC/S GMP standards are the world’s strictest, and have been adopted by advanced countries in the Americas, Europe and Southeast Asia, the official added. The protocols ensure stringent quality control is maintained at all stages of the manufacturing process, starting with supply of raw materials and management of production facility, preventing such problems as cross-contamination and admixture, ensuring smooth and stable production.
The standards also govern drugs after they are approved to hit the market, with regular inspection and testing to make sure pharmaceuticals retain their quality and efficacy until expiry. (SDH)