WellsPharmatech

Quality Control

1. Raw Material Inspection

1.1. Raw Material Sourcing: Source raw materials from approved suppliers who meet regulatory and quality standards.

1.2. Incoming Inspection: Conduct thorough inspections of incoming raw materials to ensure they meet specified quality and purity requirements.

1.3. Documentation: Maintain comprehensive records of all raw material inspections, including batch numbers, supplier details, and test results.

2. Manufacturing Process Control

2.1. Standard Operating Procedures (SOPs): Develop and adhere to well-defined SOPs for the manufacturing process, ensuring consistency and product quality.

2.2. Equipment Calibration: Regularly calibrate and maintain manufacturing equipment to guarantee accurate dosing and mixing.

2.3. Batch Records: Document every step of the manufacturing process, from raw material mixing to final product packaging, to track and verify the consistency of each batch.

3. In-Process Testing

3.1. In-Process Sampling: Collect samples at various stages of production to perform in-process testing.

3.2. Testing Parameters: Establish and monitor critical parameters such as viscosity, pH, and particle size during production to ensure product uniformity.

4. Quality Assurance Testing

4.1. Finished Product Testing: Conduct comprehensive quality control tests on finished dermal filler products, including sterility, potency, and purity.

4.2. Stability Testing: Perform stability testing under various conditions to determine the product's shelf life and storage recommendations.

5. Documentation and Records

5.1. Documentation Control: Maintain detailed records of all quality control tests, inspection results, and batch records in a secure and organized manner.

5.2. Traceability: Implement a robust traceability system that allows for the tracking of products back to their raw materials and production processes.