fig. 1 —
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).
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