As a leading Rotigotine factory, Qingmupharm implements stringent quality control throughout production to ensure the medication's safety, efficacy and consistency. Here are some of the key measures used:
Raw Material Testing
All incoming raw materials like rotigotine active substance undergo identity, purity and impurity profiling. Only approved suppliers providing certificates of analysis are used. Rejected materials are quarantined.
In-Process Testing
Regular sampling checks critical process parameters like temperature, pressure and yields match defined manufacturing parameters. Intermediates are tested before further processing or packaging.
Batch Manufacturing Records
Comprehensive batch records document each step with actual values to facilitate traceability. Deviations from standard procedures trigger investigations.
Environmental Monitoring
Settled particle and air sampling check for contamination with microorganisms and particulates. Personnel also undergo monitoring to prevent cross-contamination risks.
Analytical Method Validation
In-house testing methods undergo validation studies confirming reliability, accuracy, reproducibility and specificity as per ICH guidelines before routine use.
Stability Testing Program
Product batches are kept under real-time/accelerated conditions and periodically tested to verify shelf-life meets predefined specifications and guidelines.
Statistical Process Control
Charts monitor key quality attributes to proactively detect potential drifts from target and aid continuous improvement. Control limits trigger investigations.
Calibration Management System
Critical instruments undergo scheduled calibration and adjustments to ensure accuracy and precision in test results over each piece of equipment's lifecycle.
Finished Product Release Testing
Only batches clearing identity, purity, content uniformity, microbial limits and other critical tests as per approved specifications are released for sale.
Annual Product Review
Each year's manufacturing activities and monitoring data are analyzed for quality trends to ensure continued compliance and identify enhancement opportunities.
Change Control System
Prior review and approval of facility, equipment, personnel or process alterations prevents unexpected effects on quality from undocumented changes.
Complaint Management
Thorough investigations ascertain root causes of any issues reported and corrective actions are implemented to prevent recurrence.
Supplier Qualification
Approved vendors undergo periodic audits to ensure continued supply of materials meeting quality standards.
Traceability System
Production batch records permit identification of raw material sources and full distribution chain traceability in case of quality or safety concerns.
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