During many years of experience with clients, we have encountered confusion between the terms GMP (Good Manufacturing Practice) and GLP (Good Laboratory Practice). For example, we are asked to manufacture clinical trial materials in compliance with GLP, or that bioanalysis for animal tissues will be performed under GMP conditions. Quite a few people have asked us: is there really a difference between those two?
In general, it can be said that the purpose of both GMP and GLP requirements is to protect the patients that will be using the product. To better understand the difference, let's overview briefly each of the concepts.
GMP in a nutshell
Good Manufacturing Practice (GMP) is a set of regulatory requirements that ensures consistency and safety during the manufacturing of products for human and animal consumption (drugs, medical devices, food and beverage, cosmetics, and food supplements). Although the requirements vary between industries and geographies, the purpose of GMP is the same: keeping the safety of the consumer.
The GMP system applies to all aspects of manufacturing, testing, and quality assurance of the product- from raw materials quality to manufacturing procedures and QC testing. Dozens of regulatory requirements must be embedded by the production facility in order to achieve a quality product, including a strong quality management approach, proper production facilities, well-trained personnel, proper documentation and archiving, controlled storage environment, and more. The GMP requirements also apply to the post-production phase, and the manufacturer must be obligated to monitor the product in the clinical trial/market and provide a strong recall system (pharmacovigilance).
GLP in a nutshell
Good Laboratory Practice (GLP) quality system is the set of regulatory binding principles. These principles are used to guarantee the validity of the safety data generated during the non-clinical phases. Unlike GMP, GLP applies not only to products for human and animal consumption but also to environmental chemistry such as pesticides and other non-pharmaceutical products.
The GLP system requires that all procedures and testing will be extensively documented in a very accurate manner, so that the quality and reliability of the data is ensured.
GMP vs. GLP
There are two main differences between GMP and GLP quality systems. The first difference is that they both refer to different stages and processes in the developmental path of products. While the GLP principles refer to laboratories engaged with preclinical testing, including in-vitro and animal testing, bioanalytical methods. etc.. The GMP requirements apply to all products manufactured for human patients, from first-in-man trials to mass production.
The second main difference is the definition of the QA role between the two systems. The role of the QA team according to the GLP principles is to serve as the extension or long arm of the regulator. This means that the QA is not expected to interfere in the planning of the various processes, but only to audit them. If issues that require further reference arise during the audit, the QA is not entitled to suggest corrective actions. In processes carried out under the GMP requirements, the QA is an integral part of the team, from planning the activities and proposing preventing actions, through responding to questions as they arise, to reviewing the processes and proposing corrective actions if needed.
Did you know?
The campaign for the OECD-GLP recognition in the Israeli-GLP was led by Dr. Orna Dreazen, former General Director of the Israel Laboratory Accreditation Authority (ISRAC). This campaign was a great success, and in 2002 ISRAC was recognized as a full member of the OECD-GLP working group, long before the State of Israel became a member of the OECD.
Dr. Dreazen currently serves as the CEO of Nextar's Chempharma Solutions.
1. World Health Organization (WHO) GMP Questions and Answers: https://www.who.int/medicines/areas/quality_safety/quality_assurance/gmp/en/
2. World Health Organization (WHO) Good Laboratory Practice (GLP) Handbook: https://www.who.int/tdr/publications/documents/glp-handbook.pdf