Welcome to GMP Certification

Good manufacturing practice (GMP CERTIFICATION) guidelines provide guidance for manufacturing, testing, and quality assurance to ensure that a food or drug product is safe for human consumption. Many countries have legislated that food and pharmaceutical and medical device manufacturers follow GMP procedures and create their own GMP guidelines that correspond with their legislation.

A GMP is a quality assurance system that helps ensure pharmaceutical products are consistently produced and controlled according to quality standards. It is designed to minimize risks throughout the production process that cannot be eliminated through testing the final product. GMP covers all aspects of production, from starting materials and premises to the training and personal hygiene of staff. Detailed written procedures are essential for each process that could affect the quality of the finished product. There must be systems in place to provide documented proof that correct procedures are consistently followed at each step of the manufacturing process.

The U.S. Department of Agriculture's Food and Safety Inspection Service (FSIS) and the Food and Drug Administration (FDA) enforce HACCP certification, which is a scientific process control system designed to eliminate contaminants at critical areas in the food production and distribution process. By achieving HACCP certification, food producers and distributors can help prevent, as close to 100% as possible, harmful contamination in the food supply system.

Benefits of GMP Certification:

• Manufacturing facilities must maintain a clean and hygienic manufacturing area.
• Controlled environmental conditions to prevent cross contamination of food or drug product from adulterants that may render the product unsafe for human consumption.
• Manufacturing processes are clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications.
• Manufacturing processes are controlled, and any changes to the process are evaluated. Changes that affect
• The quality of the drug are validated as necessary.
• Instructions and procedures are written in clear and unambiguous language. (Good Documentation Practices)