GMPGLP

GMPGLP is not a single formal standard but a term used to describe the integration of Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) principles in pharmaceutical development and manufacturing. GMP covers the production of medicines to ensure safety, quality, and identity; GLP covers non-clinical laboratory studies to ensure data integrity and reliability used in regulatory submissions.

In practice, GMPGLP implies that a company aligns its quality management system to satisfy both manufacturing and testing requirements. This includes documented standard operating procedures, equipment qualification, process validation, facility controls, personnel training, change control, deviation handling, and supplier qualification. Data generated in GLP studies must be traceable and auditable, with appropriate archiving and study oversight.

Organizational structure typically includes a quality assurance unit, a separate quality control laboratory, and a regulatory compliance function. Regular internal audits and external inspections by authorities (for example, FDA or EMA) assess compliance with GMP and GLP principles. Non-conformities are managed through corrective and preventive actions (CAPA).

Benefits of adopting an integrated GMPGLP approach include improved product quality and safety, strengthened data integrity, and smoother regulatory submissions. Challenges include the need for significant investment in systems, training, and infrastructure, as well as maintaining consistency across complex operations and studies.

Regulatory references commonly cited alongside GMP and GLP include ICH guidelines and OECD GLP principles; manufacturers must comply with applicable national regulations in their operating regions.