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制剂企业在供应商的年度回顾中应从原料药的起始物料开始回顾（牵涉到相应的原料药供应商提供相应的数据信息），而不仅仅从原料药开始回顾，大家怎么看？？Supply Chain TraceabilityI only have to re-state who manufactures the API in my PQR and as we’ve always used the same company that’s easy.
No, that’s not the requirement. Finished Drug Product manufacturers are required to carry out Product Quality Reviews periodically and EU Guideline Chapter 1 1.10 i) now requires ‘review of supply chain traceability of active substances’. This is often misinterpreted by companies as simply being a requirement to state the manufacturer and supplier of the API, but actually the requirement is to fully map all the parties involved in the supply chain and periodically re-assess this for accuracy. Chapter 5 5.29 provides more detail on this and makes it clear that the Active Substance supply chain traceability starts at the ‘active substance starting materials’ i.e. the Registered Starting Materials for the API manufacturing process. 5.29 For the approval and maintenance of suppliers of active substances and excipients, the following is required: Active substances Supply chain traceability should be established and the associated risks, from active substance starting materials to the finished medicinal product, should be formally assessed and periodically verified. Appropriate measures should be put in place to reduce risks to the quality of the active substance. The supply chain and traceability records for each active substance (including active substance starting materials) should be available and be retained by the EEA based manufacturer or importer of the medicinal product. | 
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发表于 2017-8-10 11:16:12
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