Pharmaceutical Quality
Pharmaceuticals and drug delivery systems require a great deal of discipline to attain both efficacy and profitability. The pipeline of new products and the increased scrutiny that drugs must pass are but two of the many challenges for the industry. Each new compound and the means in which it is delivered must consider not only the impact on the patient but also on the care givers themselves.
Quality Associates International has over 10 years of experience managing the risk, verification and validation of these products by providing intelligent processes and discipline in quality and reliability. This experience and knowledge has resulted in:
- Detailed risk mitigation process and traceability.
- Process and manufacturing controls driven from the risks that were determined during the design phases.
- Process Control Plan Methodology
- Increased confidence in clinical trial results.
- Improved Design Verification and Validation plans.
- Increased security for expensive raw materials and components
- Robust design inclusion in the primary product design
- Improved documentation and warnings for patients and caregivers.
- Product Liability
- Installed Quality Management Systems for compliance to regulations.
- Good Manufacturing Practices (GMP)
- IMS - Integrated Management Systems
- Installed prevention processes to assure quality of the product.
- Poka-Yoke / Errorproofing and Mistakeproofing
Need more information?For more detailed information on this topic please email our qualified staff , contact us by phone at (248) 280-4800, or fill out our Contact Form.