GMP in Pharma Manufacturing—Description of GMP as Related to Air-Handling Units and Prevention of Contamination and Implementation of GMP Regulatory Requirements

Drug substances and drug products are used for treating various diseases to save the lives of human beings. Drug substances and drug products should be manufactured using clean equipment with appropriate quality and in good environmental condition to avoid contamination of the product and to produce the desired therapeutic effect. Effort should be made to build quality into the product during each stage of the manufacturing process rather than simply testing the product. To regulate the manufacturing process, regulatory agencies along with pharmaceutical industrial organizations developed good manufacturing practice (GMP) guidelines for the preparation/manufacturing of the drug substance and drug products. Various GMP guidelines are followed in respective regions in the world even though the fundamentals of all the guidelines remain the same. The GMP guidelines consist of various processes including quality management, personnel, personal hygiene and qualification, building and facilities, sanitation, documentation and records, material management, production and in-process controls, packaging and labeling of drug substances and drug products, storage and distribution, laboratory controls, validation, rejection and reuse of materials, complaints and recalls, and change control. Clean equipment, cleanrooms, and environmental conditions are critical process parameters to be monitored strictly in the manufacturing process to ensure the highest standard of quality and purity of the product with desired safety and efficacy of the drug product to meet the regulatory requirements.