Quality Control (QC) is corely compliant with the Chinese Pharmacopoeia, GMP and ICH guidelines, and runs through all operational links. It implements control over sampling, inspection, judgment and reporting for raw materials, intermediate products and finished products, providing data support for pharmaceutical quality.

I. Incoming Material Quality Control

Core Requirement: 100% full-item inspection for each batch of active pharmaceutical ingredients (APIs), excipients and pharmaceutical packaging materials; non-conforming materials are strictly prohibited from warehousing and production use.

Sampling: Conducted by certified personnel in accordance with SOPs, with standardized labeling and recording, and samples stored in zoned areas.

Inspection: Full-item testing in line with statutory and supplier standards, focusing on the core indicators of all types of materials.

Judgment and Release: Qualified materials are approved for release; non-conforming materials are segregated, and QA initiates deviation disposal.

Sample Retention: Retain samples of qualified materials in accordance with relevant requirements.

II. In-process Production Quality Control

Core Requirement: Conduct in-process inspection on intermediate products to ensure all inspection indicators meet the standards.

Sampling: Performed on-site in clean areas, with immediate inspection and correlation to production batch records.

Core Inspection: Focus on Critical Quality Attributes (CQAs), and implement differentiated control over indicators of key process nodes.

Judgment and Adjustment: Qualified intermediate products are approved for release; production is suspended for recheck in case of non-conformity, with process adjustment and reinspection conducted subsequently. Deviation investigation shall be initiated if non-conformity persists after reinspection.

Sample Retention: Retain samples of qualified materials in accordance with relevant requirements.

III. Finished Product Ex-factory Quality Control

Core Requirement: 100% full-item inspection for each batch of finished products, with registration standards as the supreme criterion; non-conforming finished products are strictly prohibited from ex-factory release.

Sampling: Random sampling conducted in the warehouse; sampling of special preparations operated in compliance with specified environmental requirements, with information correlated to the entire process.

Inspection: Covering three core modules – identification, tests and assay, including general indicators and preparation-specific indicators.

Judgment and Reporting: Issue inspection reports with traceability for qualified products; segregate non-conforming products, with QA leading deviation and CAPA disposal.

Sample Retention: Retain samples of each batch in accordance with requirements, conduct regular stability studies, and keep samples for the specified period.

IV. Warehousing Process Quality Control

Environmental Monitoring: Regularly inspect the temperature, humidity and cleanliness of the warehouse, and conduct timely adjustment and recheck in case of abnormalities.

Finished Product Random Inspection: Conduct random sampling inspection on finished products near expiry date and those requiring special storage; expand the inspection scope in case of abnormalities and refer to QA for disposal.

V. Abnormal Situation Disposal

Abnormalities shall be handled in accordance with the process of recheck and investigation - deviation confirmation - corrective and preventive actions - validation and closed loop, with full records filed for the entire process to eliminate the recurrence of similar risks.

VI. QC Supporting Management

Ensure the standardization, accuracy and traceability of all inspection activities, covering full SOP coverage, instrument and reference material management, record control, personnel and environmental management, as well as method validation/verification.