Compliance in the Lab: GMP vs GLP in Laboratory Studies

Compliance in the Lab: GMP vs GLP in Laboratory Studies

The life sciences manufacturing industry is full of Good Practice standards. Every step and process is covered under some GxP; from design and testing to the manufacturing and distribution of pharmaceutical products and medical devices. 

 

When it comes to laboratory processes and validation studies, there is often confusion between Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).

Comparing GMP and GLP 

Generally speaking, GLPs are research and study-focused, while GMPs are production and process-focused. However, they have a few other significant differences better understood by defining each.

What is GLP?

GLPcompliance monitors conditions, processes, documentation, and archiving of studies performed in laboratory settings. Such endeavors require highly accurate and trackable data as well as high-quality results in order to validate and market the final product. The integrity of the data is critical for developing replicable results, as well as the product’s progress to market.

What is GMP?

GMP compliance refers to quality assurance in the manufacturing processes, as defined by the local regulatory body to ensure the safety of healthcare products sold in their jurisdiction. “cGMP,” which is essentially just “current” GMP, outlines the specific conditions under which manufacturing can and should occur.

GLP & GMP - When & Where?

Knowing the differences between GMP and GLP can help differentiate which protocol is called for at which phase of production. The same general principles and requirements apply to the development of drugs, biologics, and medical devices. However, GMP and GLP affect different stages in the processes.

When is GLP applied?

GLP is required during nonclinical laboratory safety studies supporting research and marketing of biocompatibility, toxicology, pharmacology, and other medical products. During “test systems” studies, GLP is also necessary in regards to handling live organisms or microorganisms, as well as plants. In addition, safety and efficacy testing should be performed under GLP.

When is GMP applied?

GMP standards are applied during the batch / lot release (or lot conformance), manufacturing & testing, and medical product marketing phases. Per the facility, the testing phase of components used in clinical trials (active pharmaceutical products, critical excipients) may require GMP compliance. As may testing of stability, process validation, and other supporting activities.

Best Practices in The Lab of The Future

Science and technology are advancing. The steps to take to market a medical product to the public are subject to change, as are the regulations that protect the end users of these products. The impact of automation, AI and augmented reality technologies compliance in the lab is likely to grow. As a result, forward-thinking manufacturers in the life sciences industry are actively looking to adopt innovative technologies to streamline processes and minimize the chances for human error.

 

Read the full post on the DotCompliance Life Science Blog