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 system for ensuring that products are consistently produced and controlled per quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. GMP covers all aspects of production from the starting materials, premises and equipment 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 to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process – every time a product is made.
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)
- Operators are trained to carry out and document procedures.
- Cross contamination with unlabeled major allergens is prevented.