GMP

Good Manufacturing Practices (GMP) is the quality assurance component that ensures medicinal products are manufactured and controlled in compliance with quality standards that are appropriate for their intended use and as specified by the product specification.

Good Manufacturing Practice (GMP) establishes general procedures to ensure that the processes necessary for production and testing are precisely specified, validated, evaluated, and recorded, in addition to defining quality metrics for production and quality control. GMP also ensures that the workers, facilities, and supplies are appropriate for producing pharmaceuticals and biologicals, such as vaccines. The legal aspects of Good Production Practices (GMP) encompass distribution obligations, contract production and testing, and responses to product defects and complaints. Several annexes contain special GMP requirements for various product categories and the overall GMP standards. Sterile medications and biological medical supplies are included in these annexes.