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ISO15378药品原始包装材料体系
ISO 15378：2006 药品原始包装材料体系认证
-关于良好生产规范，ISO9001：2000应用的特殊要求
Pharmaceutical Packaging Materials History
Specifications - Company and National
Quality Visits - Company
Standards - Company
AQL’s - Company (BS 6001)
Audits - Company
Code(s) of Practice -
Code(s) of Practice -
PS 9000 -
PS 9004 -
ISO 15378 - International 2006
ISO 15378 key point
Risk analysis and criticity(fmea)
Checking/qualification/validation:
Manufacturing tools
Computerized systems
Contamination risk & cleanliness control
Traceability
Change control
Operator training in GMP practices