Responsibilities of the Quality Unit

The quality unit(s) should be involved in all quality-related matters.

The quality unit(s) should review and approve all appropriate quality-related documents.

The main responsibilities of the independent quality unit(s) should not be delegated. These

responsibilities should be described in writing and should include, but not necessarily be limited to:

1. Releasing or rejecting all APIs. Releasing or rejecting intermediates for use outside the

control of the manufacturing company

2. Establishing a system to release or reject raw materials, intermediates, packaging, and

labeling materials

3. Reviewing completed batch production and laboratory control records of critical

process steps before release of the API for distribution

4. Making sure that critical deviations are investigated and resolved

5. Approving all specifications and master production instructions

6. Approving all procedures affecting the quality of intermediates or APIs

7. Making sure that internal audits (self-inspections) are performed

8. Approving intermediate and API contract manufacturers

9. Approving changes that potentially affect intermediate or API quality

10. Reviewing and approving validation protocols and reports

11. Making sure that quality-related complaints are investigated and resolved

12. Making sure that effective systems are used for maintaining and calibrating critical

equipment

13. Making sure that materials are appropriately tested and the results are reported

14. Making sure that there is stability data to support retest or expiry dates and storage

conditions on APIs and/or intermediates, where appropriate

15. Performing product quality reviews