Good Manufacturing Practice fundamentals

Good Manufacturing Practice (GMP) is a system of mandatory, internationally recognized, and regulated standards that ensures products primarily pharmaceuticals, food, and cosmetics are consistently produced and controlled to strict quality standards. It minimizes production risks, such as cross-contamination, mislabeling, or adulteration, by requiring detailed documentation, trained personnel, validated processes, and proper facilities.

GMP defines quality measures for both production and quality control and defines general measures to ensure that processes necessary for production and testing are clearly defined, validated, reviewed, and documented, and that the personnel, premises and materials are suitable for the production of pharmaceuticals and biologicals including vaccines. GMP also has legal components, covering responsibilities for distribution, contract manufacturing and testing, and responses to product defects and complaints. Specific GMP requirements relevant to classes of products such as sterile pharmaceuticals or biological medicinal products are provided in a series of annexes to the general GMP requirements.

Key Aspects of GMP

• Purpose: To guarantee that products are safe, pure, effective, and of high quality, protecting both the consumer and the manufacturer.

• Scope: Covers all aspects of production, from raw materials and premises to equipment training and personal hygiene.

• Core Requirements:

  • Documentation: Clearly defined, written procedures for every process.

  • Validation: Evidence that processes work as intended.

  • Hygiene & Training: Well-trained staff adhering to sanitation standards.

  • Quality Control: Testing for, rather than relying on final product inspection.

• Regulation: Enforced by agencies like the FDA (U.S. Food and Drug Administration) and Health Canada.

Often referred to as cGMP ("current" GMP), this indicates that manufacturers must use the most up-to-date technologies and systems to comply.