What are the 10 principles of GMP?

Good Manufacturing Practice (GMP) is a system designed to ensure that products are consistently produced and controlled according to established quality standards. It’s designed to minimize the risks involved in any pharmaceutical production.

In answering the question – What are the 10 principles of GMP?

Here are the 10 principles of GMP:

  1. Written Procedures and Instructions: Detailed, written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process.
  2. Facilities and Equipment: Facilities and equipment should be properly designed, maintained, and cleaned to ensure the quality of products. Equipment validation and calibration are also crucial for maintaining consistent operations.
  3. Materials: All materials used in a manufacturing process must be of tested quality, clearly identified, and readily traceable. This includes both the product’s ingredients and the specific containers and closures that will be used.
  4. Production: Manufacturing processes are clearly defined, controlled, and validated to ensure consistency and compliance. Critical processes are validated to demonstrate that they are capable of consistently delivering quality products.
  5. Quality Control: Products must be tested at different stages of production to verify quality. These tests should ensure the identity, purity, potency, and quality of the product.
  6. Documentation: Records, raw data, and documents related to production and distribution should be retained and available for review. They should be clear, comprehensive, and accurate.
  7. Personnel: Qualified and adequately trained personnel are essential. Every person involved in manufacturing should have the education, training, and experience to perform their role effectively.
  8. Validation and Change Control: Changes to the manufacturing process must be properly reviewed, validated, and documented to ensure the quality of the product isn’t compromised.
  9. Complaints and Recalls: There should be systems in place for handling complaints and product recalls. This involves reviewing and investigating complaints and taking appropriate corrective actions when necessary.
  10. Auditing (Self-inspection and Quality Audits): Regular audits should be conducted to ensure that GMP guidelines are being followed. These audits can identify areas for improvement and ensure that corrective actions are implemented.

These 10 principles of GMP form the foundation of GMP and are designed to provide a structure for a strong quality management system (QMS) or Pharmaceutical Quality Management System (PQS). They help ensure that pharmaceutical products are consistently high in quality, safe for use, and fit for their intended use.

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PIC/S GMP regulations can we found here.