A traceability system is in place, including tracing back from the final product through quality control data and batch records to the raw materials used and the suppliers?
现场是否有可追溯体系,包括通过质量控制数据和批次记录,由最终产品追溯到所有的原材料和供应商?
These records should include dates, quantities, batch/serialnumbers, expiration dates (if applicable), and the unique code numbers assignedto the investigational product(s) and trial subjects.
这些记录应包含日期、数量、批号/系列号、时效期(如有)、和分配给试验用药品和试验对象的特别编码。
The sales records, including but not limited to product name, specification, type, batch, sale destination and quantity, should be kept for inquiry from the very first sale of product in Euro Union.
在欧盟销售第一批或第一件产品起,保持销售记录供查询,包含品名、规格、型号、批号、销售目的地、数量等。
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