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March 14, 2013: Guangdong Otsuka plastic bottles workshop and soft bag workshop through the new GMP certification

Date:2013-3-14

China 2010 edition of "drug production quality management standards" was implemented in March 1, 2011, and has held the "drug GMP certificate" of blood products, vaccines, injections and other sterile drugs in December 2013 31 before the new version of GMP certification, other categories of drugs in December 2015 31 before the new version of GMP certification.
In accordance with the company's business plan, plastic bottle of GOP1 workshop and soft bag infusion workshop required in the end of 2012 or early 2013 in advance of the new version of GMP certification.
In order to conform with the international GMP, the revision of the new version of the GMP WHO and the European Union GMP GMP, in the 98 version of the GMP based on a substantial revision, especially for the hardware and software requirements more stringent, objectively increased the difficulty of authentication. We need in a short time, and the task is heavy, try to interpret a new version of the GMP, will be less than point listed, after the analysis and discussion to develop measures, and implement rectification as soon as possible.
In 2012, the company's staff to make unremitting efforts, work together to fight, and invited the GMP expert on-site guidance. January 2013, plastic bottle based infusion GOP1 workshop and soft bag infusion workshop successfully passed the national food and drug supervision and Management Bureau of the new version of the GMP certification certification on-site inspection, and obtained the GMP Certificate in March 14th.
In 2013, we will continue to work hard, to refer to the certification experience, to carry out the new GMP certification preparation work in the workshop of oral solution.

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