Solution  BY  Communication  | Language: Chinese
Audit Guide
3.1 Production process flow diagram? 
3.2 Plant, facilities maintenance is in good condition? 
3.3 The key equipment is specialized cleaning methods? 
3.4 Clean storage containers to meet the requirements? Is there a risk of secondary pollution? 
3.5 Production site with equipment operating procedures and use of records, the record is complete? 
3.6 The running equipment meets the requirements to ensure that safety and cross-contamination risk? 
3.7 Recycling of tails is performed as required, and timely records? 
3.8 Whether the strict implementation of batch packing packing instruction? 
3.9 A sterile operating region of the operator's operating behavior is normative? 
3.10 A sterile operating area in the production operation process whether the operating environment for dynamic monitoring, checker monitor and record whether it meets the requirements? 
3.11 Access to sterile operating area of the material, equipment, containers and disinfectant sterilization and disinfection, whether through ( or sterilization) processing? 
3.12 Access to sterile operating area of the material, intermediate product transfer process can ensure no pollutions? 
3.13 Batch partition principles, batch management have traceability? 
3.14 Batch partition is consistent with the provisions?
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