Johnson & Johnson and other major manufacturers used industrial-grade raw materials to make drugs; the Ministry of Health and Welfare inspects 103 pharmaceutical plants
The tainted-medicine scandal keeps spreading. In addition to Mu Tsun and Zheng Chang Sheng Pharmaceutical, authorities have successively found that three more pharmaceutical plants - Johnson, Ren Sheng and Wei Ta - bought industrial-grade magnesium carbonate and calcium carbonate raw materials from upstream chemical manufacturers and used them to make seven related products, which are now being continuously pulled from shelves, recalled and destroyed. The Food and Drug Administration held a press conference in the evening, saying it would launch a comprehensive special investigation plan, giving priority to inspecting the 103 domestic pharmaceutical plants that use magnesium carbonate and calcium carbonate raw materials and have passed PIC/S GMP certification; the inspection work is expected to be completed within 2 months.
Tainted-medicine scandal spreads: the Ministry of Health and Welfare will comprehensively inspect 103 domestic pharmaceutical plants
News glossary:
What is the PIC/S GMP pharmaceutical quality mark?
The PIC/S GMP standard (Pharmaceutical Inspection Co-operation Scheme Good Manufacturing Practice Guide) is currently the most rigorous pharmaceutical manufacturing standard recognized worldwide and adopted by advanced countries in Europe and America as well as various countries in Southeast Asia. It starts from the very source of drug manufacturing, covering the quality of raw materials, suppliers, the management of plant facilities and equipment, and even the vetting of on-site personnel.
Taiwan's, China western-medicine plants completed a full upgrade from GMP and cGMP to PIC/S GMP certification at the end of last year, so if a pharmaceutical plant illegally uses industrial-grade raw materials, it not only violates the Pharmaceutical Affairs Act but also violates the PIC/S GMP standard; besides being able to halt production, if the addition was deliberate or malicious and the circumstances are serious, its PIC/S GMP qualification will also be revoked.
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