Our company has established an independent, strict and sound quality mangement system in accordance with GMP 2010 and ICHQ7a, delivered by the two executive organs QA and QC. Seven APIs have obtained Chinese GMP in 2016.
QA is responsible for the supervision of the quality during the production to ensure that production is operated in accordance with GMP and product quality meets the required specifications.
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 labelling 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 and making sure that internal audits (self-inspections) are performed;
5. Approving all specifications and master production instructions and approving all procedures impacting the quality of intermediates or APIs;
6. Approving intermediate and API contract manufacturers and approving changes that potentially impact intermediate or API quality;
7. Reviewing and approving validation protocols and reports;
8. Making sure that quality related complaints are investigated and resolved;
9. Making sure that effective systems are used for maintaining and calibrating critical equipment;
10. Making sure that materials are appropriately tested and the results are reported;
11. Making sure that there is stability data to support retest or expiry dates and storage conditions on APIs and/or intermediates where appropriate；
12. Performing product quality reviews.