中药材GAP认证，中药材生产企业GAP认证前期工作
Chinese herbal medicine Chinese herbal medicine production enterprises GAP certification, GAP certification work
从2003年11月国家食品药品监督管理局开始对陕西天士力等首批8家企业实施中药材认证开始，截至目前为止，已有47家中药材生产企业接受了中药材GAP现场检查，其中26家企业分三批进行了公告，其余企业的公告正在陆续进行中。许多企业已经建立或正在建立中药材生产基地，但是如何建立生产基地，如何进行认证申请，不少企业尚感困惑。在审查企业报送的资料时，有些企业因准备工作不足而遭到退审，因此如何更有效去准备GAP认证，是许多中药材生产企业迫切需要探讨的问题。现仅就前一阶段在检查认证中发现的问题加以说明，供各企业参考。
From 2003 November the State Food and Drug Administration began to Shaanxi in the 8 enterprises to implement Chinese herbal medicine certification, so far, there have been 47 Chinese herbal medicine production enterprises to accept Chinese herbal medicine GAP on-site inspection, of which 26 enterprises in three batches of the announcement, the announcement enterprises are gradually in. Many enterprises have built or are building production base of Chinese herbal medicines, but how to establish production base, how to apply for certification, many enterprises still feel confused. In a review of the documents submitted by the enterprises, some enterprises due to the deficiencies in the work and was disapproved, how to more effectively to prepare GAP certification, is one of many Chinese herbal medicine production enterprises are in urgent need to explore the issue. Now only the previous stage in the inspection certification problems found to illustrate, for the reference of enterprise.
1 前期准备工作
1 preparatory work
    中药材GAP检查认证是对企业实施GAP工作的全面考查与评估。它涉及的范围很广，主要包括硬件系统和软件系统，两者是相辅相成的，检查认证目的是促使企业按GAP要求，对照认证标准，逐项规范操作规程，从而对药材生产全过程进行控制，以达到保证中药材质量稳定、均一，可控的目的。认真做好申报前的准备工作，是企业顺利通过GAP认证的基础。
Chinese herbal medicine GAP certification is the implementation of enterprise GAP work of the comprehensive test and evaluation. It involves a wide range, including hardware system and software system, the two are complementary, inspection certification objective is to make an enterprise according to the requirement of GAP, controlled certification standards, one standard operating rules, so as to control the whole process of production of the medicinal material, to ensure the quality of the medicinal material in stable, uniform, controllable purpose. Conscientiously do a good job of reporting the preparation work before, is the enterprise passed the GAP certification based.
1.1企业注册的准备企业首先应在工商部门登记注册，成为中药材生产企业，其范围最好是中药材生产或种植（养殖）、中药材初加工、中药材经营等。因为中药材GAP实施的主体是企业，相应地企业成为承担认证及经营的风险等责任的主体，因此必须是具有法人资格的中药材生产企业才有资格申请中药材GAP认证。
1.1 enterprises registered for enterprises should first registered in the business sector, become Chinese herbal medicine production enterprise, its scope is the best medicine production or plant (breeding ), Chinese herbal medicine, Chinese herbal medicine business in early processing. Because the GAP of the medicinal material in the implementation main body is an enterprise, the enterprise should be certification and management risk and responsibility main body, so it must be with legal personality of the Chinese herbal medicine production enterprises are eligible to apply for GAP attestation of Chinese herbal medicines.
1.2资金方面的准备实施GAP，首先要有足够的资金支持，企业可以多渠道地筹集，寻找多方面的支持，如来自国家扶持的科技项目，国家或地方科技部门、经贸部门、农业部、扶贫办、中医药管理局等，这些部门都有专门针对中药材种植的扶持资金；有的企业申请到国际环保支持资金；有来自药品生产企业的支持资金；有来自政府或私人的投资等。一旦申请成功，资金将会足够你的基地进行各项生产科研活动。
1.2 the financial aspects of the preparation for the implementation of GAP, first must have sufficient funds to support multiple channels, enterprises can be raised, looking for the support in many ways, such as from the state to support the technology project, national or local science and Technology Department, trade department, Ministry of agriculture, poverty alleviation office, administration of traditional Chinese medicine, these departments have specifically targeted at Chinese herbal medicine planting support funds; some enterprises to apply for international environmental support funds from the drugs production enterprise; funding; from government or private investment. Once the application is successful, the funds will be enough for your base for the production of scientific research activities.
1.3地产药材的调研建立GAP基地，品种和地区的选择十分重要。原则上是遵循地域性，安全性和可操作性三原则，最好首选地道品种或当地有种植历史的品种，或紧缺品种（但企业必需拥有种植技术或科研积累），企业建立基地贵精不贵多，集中精力搞好一个品种的种植，取得经验后再考虑其它品种，同时不能放松上一个品种的管理。所选品种最好是有特色的道地药材。有的很多地区均可种植的大路性药材，除非药品生产企业自行建立的基地或供销渠道非常明朗的，否则企业最好不要选择去做。