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1. Manufacturing Facility Design and Maintenance: The manufacturing facility must be designed to prevent and control contamination, product mix-up, and errors in the manufacturing and handling process.
2. Quality of raw material used in manufacturing: Raw materials are the key ingredients of pharmaceuticals and their quality must be tested before they are used in production.
3. Validation of processes and equipment: All manufacturing processes and equipment must be validated to ensure consistent results across batches.
4. Documentation and Record Keeping – Accurate results of all manufacturing and testing activities, including processing of raw materials and equipment, must be maintained.
5. Quality control of finished products: Finished products must meet the required quality and standards. Finished products must be tested by a quality control laboratory before being released for distribution.
6. Packaging and Labeling: The packaging and labeling of the products must be accurate and must have all the necessary information printed.
7. Qualified and Trained Employees: Employees who work in the preparation and analysis of raw materials and final products must be qualified and trained for the work they perform.
8. Storage and Distribution: Pharmaceutical products produced in a GMP facility must be stored and distributed in a manner that ensures the safety and quality of the product.
9. Product Recall: If product quality problems are found, manufacturers should have procedures for product recall and investigation.
