1. Personnel hygiene and training:
Ensure that employees follow proper hygiene practices and have received adequate training in GMP principles.
2. Facility cleanliness and maintenance:
Regularly inspect and maintain manufacturing facilities to prevent contamination and ensure a clean working environment.
3. Equipment calibration and maintenance:
Verify that all equipment used in the production process is calibrated and maintained according to GMP standards to guarantee accurate results.
4. Raw material quality and storage:
Assess the quality of incoming raw materials and their proper storage to prevent contamination and ensure product consistency.
5. Documentation and record-keeping:
Review documentation practices to ensure that all processes and activities are well-documented and traceable.
6. Process validation and control:
Evaluate the validation of manufacturing processes and the control measures in place to maintain consistency.
7. Quality control and assurance procedures:
Examine the quality control and assurance procedures to verify that they meet GMP requirements.
8. Sanitation practices:
Check the cleanliness of production areas and assess sanitation practices to prevent contamination.
9. Product labeling and packaging:
Ensure that labeling and packaging processes adhere to GMP standards and regulatory requirements.
10. Environmental monitoring:
Monitor the manufacturing environment to control factors that may impact product quality, such as temperature, humidity, and air quality.
