Solution  BY  Communication  | Language: Chinese
Audit Guide
1.1 Quality assurance system diagram 
1.2 System associated with the training or file 
1.3 Is there a file defined the responsibilities of the various departments and the responsible person
1.3.1 Institutions at all levels and personnel responsibilities are clear, detailed, and do not cross, do not miss.
1.3.2 Key personnel responsible for product release names of persons subject to change if timely inform?
1.4 Is reasonable organizational structure of of pharmaceutical excipients production and quality management? 
1.4.1 Production management department and quality control department independent of each other?
1.5 Responsibilities of various departments is clear and in a controlled state? 
1.6 Departments with adequate staff?
1.7 Whether to develop training programs for the year, after the approval of the quality manager, including business leaders?
1.8 Whether implementation of the training system and training programs?
1.8.1 Are training records? 
1.8.2 Did not participate in the training of personnel make up classes?
1.8.3 Assessment training? 
1.8.4 Unqualified personnel re-training assessment or other arrangements?
1.8.5 Whether to create a personal training file?
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