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Quality Control, Analytical Development & Quality Assurance
In pharmaceuticals, quality is everything. With expertise in chemistry, assay development, stability, quality control and quality assurance, DDR is a leader in ensuring that your processes meet the strictest of quality standards and that your human resources are utilized to their fullest.
Past projects have included:
- Analytical Assay Development
- Method Transfer and Validation
- Testing Lab Selection and Management
- Development of Stability Protocols
- Management of Stability Programs
- GMP Facility and System Audits
- Development and Management of Document Systems
- Quality Investigations
- Quality Oversight of Operations
Case Study: Stability Data
Initial Client Contact: Loss of stability program manager, no clear business process for obtaining, viewing, processing and disposition of data from contract labs;
- Reviewed both vendor data on stability testing and production of observation memos
- Performed trending analysis on stability data
- Discovered significant issues—majority of stability data being used without complete review
- Assisted in design of stability data review business processes
- Designed training slides for CQC SOPs
- Trained stability staff on data review
- Wrote regulatory filings based on stability data
- Trained staff on methods
Quantitative Impacts: 100% of stability data now reviewed. DDR able to run program for client more accurately and less expensively than hiring internal staff.