Quality Control

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).