R&D and Production
- Process Development
- GMP Manufacturing
- Quality Control
- Supporting Services
JOINN Bio’s Quality team is committed to provide the highest quality products and services to clients.
Our QA system has the following attributes:
· Highly experienced team committed to complying with all appropriate regulations.
· Quality Management System fully aligned with the applicable regulatory guidelines.
· Promote an engaged workplace culture that values continuous quality improvement.
· Ensure a suitable quality policy communicated and understood by all employees.
· Periodically evaluate and continually improve the effectiveness of the quality system.
· Define processes for establishment, regular review, and improvement of quality objectives.
· Experienced validation team to lead facility, equipment and process validation projects.
· Expertise in managing the qualification of materials, vendors and service providers.
· Well-experienced in performing internal/external audits and managing regulatory inspections.
Our QC department has the following capabilities:
· Transfer, develop, optimize, and qualify / validate analytical test methods by exceptionally skilled analysts; full test method life cycle support.
· Provide in-house analytical testing capabilities to support ongoing cGMP operations.
· Perform USP and other compendial monograph tests.
· On-site raw material testing and release.
· On-site environmental monitoring and trending.
· Conduct in-process material and final product release tests.
· Develop and execute product storage and stability testing programs; analyze and trend stability data for expiry development and confirmation; qualify / validate stability-indicating test methods.
· Reference material production, qualification, and maintenance.
· Support process development/improvement and process validation projects (e.g., comparability and forced degradation study design and execution).