... verification. 工厂所有区域的评估,包含质量控制,健康安全,环境等。 Records to be accessed 审核记录要求 Site Audit 现场审核: ...
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策划和实施审核以及报告结果和保持记录(见4.2.4)的职责和要求应在形成文件的程序中作出规定。
The responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records (see 4.2.4) shall be defined in a documented procedure.
生产结束后审核批生产记录,确保生产过程符合工艺规程要求和GMP要求。
Review batch production record after production finished, assure production process conform to process procedure GMP requirements.
根据生产规程以及GMP要求对批次记录以及制程控制报告进行审核。
Review batch record and In-process control report according to process procedure and GMP requirement.
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