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当国内医药界还在争论是否应该降低GMP认证标准时,当众多制药企业正在为如何通过GMP认证而愁眉不展时,当一些企业因投入巨资而又未通过GMP认证感到惋惜时,当少数企业已通过认证却又觉有些后悔时,拜耳医药保健有限公司质控部经理王丽丽的一席话,着实让我们感到有些意外。她说:“我们并不认为GMP认证是一项浩大的工程,也毋需争论公司是否要通过GMP认证,即使国家不进行认证,我们自己也要进行认证(指拜耳总公司的认证)而且我们自己认证的标准有些比我国现行的GMP认证标准吏加严格。我们认为,GMP是每个制药企业的一项基础工作,通过认证是必须的,没有商量的余地”。从这我们初步感受到了世界先进制药企业对质量的理解。
When the domestic medical community is still debating whether to reduce the GMP certification standards, when many pharmaceutical companies are frowning about how to pass GMP certification, when some companies feel pity because they have invested heavily in GMP certification but do not feel sorry when a few companies When we passed the certification and felt some regrets, the speech of Wang Lili, the manager of quality control department of Bayer Health Care Co., Ltd., actually made us feel a little surprised. She said: “We don’t think that GMP certification is a huge project, and it is also urgent to argue whether the company must pass GMP certification. Even if the country does not conduct certification, we must also conduct our own certification (refer to the Bayer Corporation’s certification) and we Some of our own certification standards are stricter than our current GMP certification standards. We believe that GMP is a basic work for each pharmaceutical company, and certification is a must and there is no room for negotiation.” From this we have initially felt the understanding of the quality of the world’s advanced pharmaceutical companies.