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Xuzhou City, the Food and Drug Authority to further regulate the pharmaceutical manufacturing enterp

Addtime:2012.07.24 Source:Zhejiang Jiuxu Pharmaceutical Co., Ltd. Hits:13000
Pharmaceutical production and quality management practices (Amendment) and the National Bureau in 2010 on drug GMP certification process on specific issues notice "(State Food and Drug Safety [2004] No. 108), the Urban Council to strengthen the area of ​​pharmaceutical productioncommissioned the inspection, supervision and management, included in the regulation of pharmaceutical production processes an important one. First, strictly regulate commissioned the inspection behavior. Pharmaceutical production companies commissioned the inspection on the qualifications of the trustees of the test equipment, personnel quality, and management system, a comprehensive assessment to confirm that the conditions are met before the signing of a commission inspection contract, declaration enterprises to meet the requirements, in accordance with reporting procedures preparation of related information, fill in the pharmaceutical production companies commissioned the inspection record form ", Council for review on the declaration submitted to the provincial bureau confirmed. The second is to strengthen the daily supervision of the commissioned test. PUC "drug manufacturers, commissioned the inspection record" into the file of corporate governance, commissioned the inspection behavior in day-to-day supervision in enterprises included in the scope of the inspection. Establish a regular inspection regime to ensure that on-site inspection at least twice annually commissioned the inspection of pharmaceutical manufacturing enterprises. Commissioned the inspection of illegal behavior, and immediately report to the provincial bureau.
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