关于加强保健食品原料监督管理有关事宜的通知(国食药监许[2011]123号)
On the strengthening of the raw materials of health food supervision and management related issues notice (the country feeds medical inspect made [2011] 123 date)
各省、自治区、直辖市食品药品监督管理局（药品监督管理局），有关单位：
The provinces, autonomous regions, municipalities directly under the food and Drug Administration ( Drug Administration ), the relevant units:
　　为进一步加强保健食品原料监督管理，确保保健食品质量和食用安全，根据《中华人民共和国食品安全法》及其实施条例，现就有关事宜通知如下：
In order to further strengthen the supervision and management to ensure that the raw materials of health food, health food quality and food safety, according to the" PRC Food Safety Law" and its implementing regulations, the relevant matters are hereby notified as follows:
　　一、保健食品生产企业应当严把进货关，加强原料采购管理，对采购的原料质量负责。要严格按照《保健食品良好生产规范》的要求，切实承担产品质量第一责任人的责任，严禁采购和使用来源不明、假冒伪劣的原料。
One, health food production enterprises shall strictly stock clearance, strengthen raw material procurement management, responsible for the quality of the procurement of raw materials. In strict accordance with the" health food good manufacturing practice" requirement, cogent assume product quality responsibility, prohibited the purchase and use of unknown origin, fake and shoddy materials.
　　（一）应当与原料供应商签订采购合同，明确质量责任。采购合同中应当包括原料质量控制要求和质量指标、检验方法等质量责任方面的内容。
( a ) and raw material supplier shall sign the purchase contract, make clear quality responsibility. Procurement contract shall include raw material quality control and quality index, test methods to the quality of the content.
　　（二）应当对原料供应商进行审查，包括对原料供应商资质审核、重点原料供应商生产情况的定期现场核查等内容，并建立审查档案，做好审查记录。
( two) to the suppliers of raw materials should be reviewed, including the raw material supplier qualification review, key suppliers of raw materials production of regular on-site verification and other content, and establishment of the review archives, to review the records.
　　（三）应当建立健全检验制度，加强检验能力建设，强化原料进厂检验，并将检验报告留档备查。
( three) shall establish and improve the inspection system, strengthen the inspection ability construction, strengthen the inspection of raw materials into the plant, and the inspection report file for future reference.
　　（四）应当建立健全原料采购档案，严格执行索证索票制度，确保使用原料来源可追溯。
( four) shall establish and improve the procurement of raw materials strict implementation of archives, Sok Sok card ticket system, to ensure that the use of raw material origin traceability.
　　（五）委托生产的，委托方和被委托方要签订合同，委托方为产品质量安全第一责任人，被委托方要按照《保健食品良好生产规范》的要求对生产使用的原料严格把关，并承担相应责任。原料需要委托提取的，其原料提取工艺、质量控制指标等应当与产品注册批准的内容一致。
( five) commissioned by the production, the principal and the principal to the signing of the contract, client for product quality and safety of person of the first responsibility, entrusted party according to the" health food good manufacturing practice" requirements of the production of raw materials used strictly, and assume the corresponding responsibility. Raw materials needed by extraction, the extraction of raw materials, process and products quality control index shall be approved the registration content.
　　二、各省级食品药品监督管理部门应当采取切实措施，落实省以下各级食品药品监督管理部门监管责任，加强保健食品生产企业采购和使用原料的监管。
In two, the provincial food and drug supervision and administration departments should take practical measures to implement the province at all levels, the food and drug administration supervision responsibility, strengthen the health food production enterprises of raw materials procurement and use of supervision.
　　（一）重点加强对采购和使用蜂胶、阿胶等价格昂贵、产量有限、动植物提取物、标示进口原料、缺乏特征性控制指标原料的保健食品生产企业的监督检查。
( a ) to strengthen the focus on the procurement and use of propolis, donkey-hide gelatin and other expensive, limited production, animal and plant extracts, mark of imported raw materials, lack of characteristic control index of raw materials of health food production enterprises supervision and inspection.
　　（二）重点加强对辖区内保健食品生产企业采购原料审查和建档情况、原料采购、检验和使用等方面的监督检查。对于不符合要求的，责令限期整改。
( two) strengthen the focus on the area of health food production enterprises procurement of raw materials are reviewed and archiving situation, raw material procurement, inspection and use of supervision and inspection. Do not meet requirements for, shall be ordered to make rectification within a time limit.