Do you ask yourself before consuming any packaged food or medicine if they are safe for your health? As the average consumer, we might not always question the safety of what we use or eat. That’s because we trust the Food and Drug Administration (FDA) to ensure quality standards for labs and manufacturers producing healthcare and edible products.
The Food and Drug Administration (FDA) has proposed good manufacturing practice (GMP) regulations and good laboratory practice (GLP) regulations for the protection of public health. These practices help ensure high-quality standards in laboratories and industries during their testing and manufacturing processes.
In addition to the people executing the procedures, the lab quality assurance (or quality control) personnel also have essential roles in GMP and GLP.
As much as GMP and GLP sound similar, there are many differences between these compliances, and confusing the two can lead to serious issues for labs or even require retesting products for quality assurance.
This article will explore GMP and GLP regulations and the key differences between these two certifications.
Please note that the information provided in this blog is for informational purposes only. We do not offer certification or accreditation services. If you are interested in obtaining certification or accreditation, we recommend contacting the relevant program directly.
Good manufacturing practice (GMP) regulations were first introduced and enforced in 1938 by the U.S. Food and Drug Administration (FDA), under the authority of the Federal Food, Drug, and Cosmetic Act. Sometimes, it’s also referred to as “current good manufacturing practices” (cGMP). “Current” reminds manufacturers to comply with the systems and technologies that are up to date and follow the regulatory standards.
GMP regulations contain some best practices for industries to help ensure the safety, quality, and efficacy of food, drugs, medical devices, and cosmetics. They enable companies and labs to minimize or eliminate instances of contamination, mixups, and errors.
GMP addresses issues related to record-keeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling. It protects customers from buying medicines and foods that may cause adverse effects on their health or harm them in any way.
GMP compliances are required during the batch/lot release (or lot conformance), manufacturing and testing, and medical product marketing phases. Furthermore, the testing phase of components used in clinical trials (active pharmaceutical products, critical excipients), testing of stability, process validation, and other supporting activities must also follow GMP regulations.
The regulations are not applied to areas where safety assessments are not a concern for discovery, in vitro studies, screening, and basic research studies.
Below are the general steps to becoming GMP certified:
According to the World Health Organization (WHO), good laboratory practices (GLP) are defined as a “quality system concerned with the organizational process and the conditions under which nonclinical health and environmental safety studies are planned, performed, monitored, recorded, archived, and reported.”
GLP provides tools and resources to ensure the high standard management of nonclinical laboratory studies. It assures the quality, reliability, and integrity of studies, the reporting of verifiable conclusions, and data traceability.
GLP promotes data integrity, quality, and validity generated during testing. It protects the public from any fraudulent health practices.
GLP regulations are applied during nonclinical laboratory safety studies, supporting research and marketing of biocompatibility, toxicology, pharmacology, and other medical products.
However, it doesn’t apply to the manufacturing and testing of medical devices (except design controls), some investigational drug products, and biologics in clinical trials. Further, it’s important to note that clinical studies involving humans are governed by good clinical practices (GCPs), the Declaration of Helsinki, and other regulations designed to protect human participants, not GLP.
Labs and manufacturers must abide by the following steps to earn a GLP certification:
GMP and GLP are federal regulations imposed by the FDA for compliance in the stages of design, testing, manufacturing, and the distribution of healthcare products. They ensure proper protocols and process validation for producing replicable results and adhering to industry standards.
GMP deals with the verification and validation of product manufacturing before products hit the market. On the other hand, GLP regulations are concerned about standard procedures, methods, and working conditions in nonclinical studies.
These regulations, however, require the maintenance of equipment used in the processes. This can be tough while also focusing on research studies, budgeting, and related tasks. If you’re in need of new equipment and want to make sure it will be well maintained or repaired during its time in use, leasing with Excedr can be a way to ensure this. We provide comprehensive service coverage with all of our operating leases.
With Excedr’s leasing program, laboratories can access the latest equipment without impeding their budget. By leasing the equipment you need, you can save on upfront costs, speed up your research and development, and reach milestones faster. Contact us today to learn more.