1. Establishing a Robust Quality Management System

• Independent Quality Department: Setting up an independent quality department responsible for reviewing and approving all quality-related documents and ensuring that significant deviations are investigated and resolved.
• Full-Process Supervision: Implementing comprehensive supervision and control from raw material procurement, through production process control, to finished product testing, release, sales, and customer feedback.

2. Stringent Quality Standards and Testing Procedures

• Quality Standard Development: Developing quality standards for intermediates based on synthetic processes and impurity control strategies, including chemical purity, solubility, heavy metal content, etc.
• Testing Requirements: Conducting necessary tests on each batch of intermediates and APIs, including impurity profiling and microbiological testing.
• Method Validation: Ensuring that analytical methods are validated to accurately reflect product quality.

3. Supplier Management and Certification

• Supplier Screening and Evaluation: Conducting rigorous screening and quality assessments of raw material suppliers to ensure they meet quality standards.
• Certification System: Establishing a supplier certification system, where only suppliers who pass reviews and on-site inspections are included in the list of qualified suppliers.

4. Documentation and Record-Keeping

• Document System: Establishing a comprehensive document system, including quality standards, operating procedures, and inspection reports, to ensure the authenticity and security of documents.
• Record Retention: Maintaining records of raw material receipt, testing, usage, etc., for traceability.

5. Packaging and Labeling Management

• Packaging Materials: Ensuring that packaging materials meet quality standards and do not contaminate the intermediates or APIs.
• Label Information: Including key information on labels, such as product name, batch number, expiration date, storage conditions, etc.

6. Continuous Improvement and Training

• Regular Self-Inspection and Improvement: Conducting regular self-inspections and quality management reviews to continuously improve the quality management system.
• Employee Training: Organizing regular GMP knowledge and operating procedure training to enhance quality awareness among all employees.

7. Compliance with International Regulations