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药品是防病治病、康复保健的特殊商品。药品质量直接关系到人民的身体健康和生命安全。因此，保证药品的安全有效是制药企业的头等大事。在药品生产中，只能采取有限的抽样检验来判断药品质量。如果生产过程中发生污染、混药或差错，仅仅依靠成品抽验很难发现问题和控制质量，
Drugs are special products for disease prevention and treatment and rehabilitation. The quality of medicines is directly related to people’s health and life safety. Therefore, to ensure the safety and effectiveness of pharmaceuticals is a top priority for pharmaceutical companies. In drug production, only limited sampling tests can be used to judge the quality of medicines. If pollution, compounding or mistakes occur in the production process, it is difficult to find the problem and control the quality just by the finished product sampling,