Biopharmaceutical Quality Assurance
It is the policy of Goodwin Biotechnology to use appropriate management systems to carry out our mission on your behalf. Quality is the intrinsic focus of all management practices that make up these systems. These practices include the following elements:
- Proper planning
- Performance of appropriate tasks
- Timely assessment
- Continuous improvement of established processes
By addressing these elements in the research, development, operations, and support activities, defined goals are met and both the Goodwin Biotechnology and your requirements are satisfied. All work is performed with dedication to excellence and with an objective of dynamic and continuous improvement.
Full Quality Assurance Capabilities
Each department at Goodwin Biotechnology involved in GMP manufacturing maintains a quality program that meets its specific needs and is consistent with the guidelines provided in the Goodwin Biotechnology Quality program. Goodwin Biotechnology Quality Assurance continually monitors these programs to assess their effectiveness. Quality Assurance is also responsible for review, approval, and control of critical processing steps, component release, and documentation in support of GMP manufacturing. Our quality systems include:
- cGMP Documentation
- Audit and Review
- Approval and Release
- Vendor Audit
- cGMP Training
- CAPA
- Biopharmaceutical Quality Assurance Consulting
Goodwin Biotechnology has established a Drug Master File (DMF).
Facilities/Equipment
Goodwin utilizes validated electronic systems to ensure compliance and to facilitate the activities associated to laboratories. The electronic systems are available across multiple areas of laboratory testing:
- Stability inventory and reporting system
- Instrument specific software
- Quality document system
Rigorous Quality Assurance
Contact us learn more about our rigorous Quality Assurance services.