GMP and GLP are regulations that have been imposed by FDA on health care product manufacturers. While GMP applies to goods that are intended for human use, GLP is a set of guidelines intended for maintenance of integrity and quality of lab data that is used by manufacturing companies to buttress the claims they make about their products. While the basic objective of both GMP and GLP is to protect the health interests of end consumers, both differ in approach and apply to different systems.
The concept of GMP, that stands for Good Manufacturing Practices, and GLP, that stands for Good Laboratory Practices, is a brainchild of FDA which was troubled by complaints it received regularly about the quality of drugs and other health care products. It proposed certain guidelines that all manufacturers accepting GMP and GLP had to adhere to, to obtain certifications from FDA. GMP is older of the two as it came into existence in 1963 while GLP was proposed in 1976 and came into existence in 1978. Together, both GMP and GLP ensure high quality of products as well as their lab procedures.
Today, GMP and GLP have become synonymous of assurance of quality. A company that has these certifications infuses confidence among the consumers that its products maintain high standards of quality and also that all correct procedures have been followed in their production.
While GLP focuses on lab testing, procedures, equipment used, manner in which data and records are maintained, testing facilities and quality control of testing, GMP is more concerned with actual manufacturing of goods and healthcare products as it pertains to the premises where goods are produced, qualifications of personnel employed, plant and machinery, and packaging processes used.
In general, GLP is considered to be less costly and cumbersome than GMP. However, manufacturing companies strive to obtain both certifications as they are proof of the quality and integrity of the company. Any company desirous of obtaining these certifications has to get personnel trained according to the provisions of FDA.
GMP vs GLP
• GMP and GLP are regulations imposed by FDA on manufacturers of healthcare products to ensure high quality and integrity of products
• While GMP pertains to goods that are intended for human use, GLP refers to laboratory practices
• GMP was introduced before GLP
• GLP is less costly and cumbersome than GMP
• GMP regulations pertain to personnel, plant and machinery and production and packaging processes while GLP pertain to lab testing, manner of keeping records and data, and quality control during lab testing.