?分发记录

All Documentation required by GMP Regulation is issued, managed and controlled by a Document Management System such as batch related documents as M-aster Batch Records - Processing and Packaging Instructions, Raw Data Records, Distribution Records, Standard Operating Procedures, Specifications, Test Methods and non batch related documents such as Qualification and Validation Documents, Complaint and Recalls Records, Environmental Monitoring Records, Utility Monitoring Records, Change Control Documentation, Engineering Drawings, Maintenance and Calibration Records, Equipment Logs, Personnel Training Records, Technical Agreements, Investigation and Reporting Records, Cleaning and Sanitization Records, Entry Records for Controlled Areas, Pest Control Records, Stability Records, Audit Reports, Regulatory Files, etc.