Quality Assurance (QA) runs through the entire life cycle of pharmaceutical products, including research and development, production, inspection, release, and post-marketing phases. Through standardized and closed-loop process control, it ensures that pharmaceutical products comply with quality standards and regulatory requirements.

I. Quality Planning and System Establishment

Regulatory Introduction: Interpret GMP, the Chinese Pharmacopoeia and other regulations, and define quality objectives and compliance bottom lines.

System Construction: Establish a complete quality management system and clarify the quality responsibilities and authorities of each department.

Standard Formulation: Formulate statutory and internal control standards for raw and auxiliary materials, finished products, etc., and specify inspection requirements.

Validation Planning: Develop validation protocols for workshops, processes, inspection methods and other aspects to avoid compliance risks.

II. Material Quality Control

Supplier Management: Conduct audit for supplier access, establish an approved supplier list and conduct regular review.

Inbound Acceptance: Review relevant documents, supervise sampling and inspection, and QA approves warehousing upon qualification.

Storage and Issuance: Supervise compliant storage, implement the first-in-first-out principle, and segregate non-conforming/pending inspection materials.

Non-conforming Material Disposal: Organize review, standardize segregation, return or destruction, and maintain closed-loop records throughout the process.

III. Production Process Quality Assurance

Pre-production Inspection: Verify the compliance of environment, equipment, personnel and other aspects, and approve the start of production.

In-process Monitoring: Conduct on-site patrol inspection, and supervise the implementation of processes, operating specifications and record filling.

Key Processes: Supervise core production processes; qualified intermediates can be transferred to the next process only after QA approval.

Deviation Management: Organize deviation investigation, formulate Corrective and Preventive Actions (CAPA) and track the closed-loop implementation.

IV. Finished Product Inspection and Release

Sampling and Inspection: QA supervises sampling; QC conducts full-item inspection and issues inspection reports.

Record Review: Conduct a comprehensive review of production, inspection and other relevant records to confirm compliance.

Finished Product Release: Upon passing the inspection and completing all records, QA conducts a review and the Qualified Person (QP) signs for release.

Non-conforming Product Disposal: Prohibit the release of non-conforming finished products, organize evaluation, standardize disposal and retain relevant records.

V. Post-marketing Quality Monitoring and Continuous Improvement

Adverse Reaction Monitoring: Collect information, conduct analysis and evaluation, report to regulatory authorities and implement corrective measures.

Quality Review: Compile annual data, evaluate quality trends and identify improvement directions.

Change Control: Assess change risks, and supervise the implementation and validation after approval.

Internal Audit: Identify problems, track corrective actions and form a PDCA closed loop for continuous improvement.

External Inspection: Cooperate with regulatory inspections, take the lead in corrective actions and submit corrective action reports.