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注册起始物料供应商审计指南（APIC 2018）以及相应的检查表
The reason for the development of this guidance is related to following: （制定原因）
- The potential disagreements between applicants and quality assessors on the suitability of proposed Registered Starting Materials (RSM).
API注册申请方和监管审评方在起始物料适合性方面存在潜在的不一致。
- Another trend is more and more often the registered starting material manufacture is outsourced to third parties. There is concern that the use of external sources may lead to a higher degree of risk to quality of the final active substance than would be expected when the RSM process is carried out by the applicant.
注册起始物料有存在委托生产的大趋势，其导致对最终API的质量风险影响成了一个重要的关注点。
- The filing description of the manufacturing process of the RSM should be sufficiently detailed to demonstrate that the process and its associated control strategy will consistently provide active substance of satisfactory quality.
申报文件关于起始物料的描述应足够充分，以证明其工艺或相关的控制策略能最终持续一致的生产出满足质量要求的原料药。
- The manufacture of the registered starting material is not in the scope of ICH Q7 guideline on Good Manufacturing Practices for API, but some of the principles of control can be applied to RSM
ICH Q7并不适用于注册起始物料，但是其相关的原则可以适用与注册起始物料。
- The expectation from Health Authorities is that the applicant has adequate control on the “good manufacturing process principles” implemented at the RSM manufacturer to control the final API quality. This guide will help industry in performing audits at RSM manufacturers to assure expectations of the health authorities.
监管部门希望API注册申请方能对“良好的生产工艺原则”在注册起始物料供应商的执行情况有充分的控制，并以此控制最终API的质量。该指南为工业界提供注册起始物料供应商的审计指导，以满足监管方的期望。
- Quality Risk Management Processes as described in the ICH Q9 Guideline on Quality Risk Management should be applied as appropriate.
ICH Q9中的质量风险管理程序应在注册起始物料供应商审计中合理利用。
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发表于 2018-4-18 11:56:29
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