Understanding the Difference between GLP GMP Requirements

gmp glp requirement

The pharmaceutical and cosmetic products need to follow several procedures and Standards while making their products or services . These practices are known as Good Practices. Two of these practices are known as Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP). The manufacturing process uses these standards to carry out their different stages successfully.

Before discussing the difference between these two, it is necessary to understand how GLP and GMP work.

What is GLP?

Good Laboratory Practices (GPL) is focused on the management of laboratory operations. In 1963 FDA proposed GLP. The GLP was proposed to prevent the exploitation of non-clinical laboratory activities.

GLP includes the proper documentation and archiving of study data, essential for supporting the end product.

What is GMP?

GMP (Good Manufacturing Practices) is a process used or followed by manufacturers to ensure that their final products meet the highest possible standards. These recommendations aid in the prevention of deviations and provide assurance of the finished product’s quality.

What is the Difference between GLP and GMP Requirements?

Both GLP GMP requirements are very different and have different roles and responsibilities. For example, a scientist performing a laboratory test may not be part of the same GMP research team as a scientist performing a manufacturing test. Understanding the GLP GMP requirements will help you identify which of them is correct for your need.

1. Study Director

One of the main differences between GLP GMP requirements is the appointment of a study director. In GLP regulations, a single person manages the complete study. While in GMP various individuals are responsible for management of the study.

2. Quality Assurance

GLP has a quality assurance unit that is responsible for inspecting the study’s integrity and compliances. Similarly, GMP also has a quality control unit that is responsible for reviewing and rejecting all the reports generated during the manufacturing process.

3. Testing Facility

One of the main differences between GLP GMP requirements is that the management of a testing facility is very distinct between GLP and GMP. It has to ensure that the facility runs efficiently.

4. Types of Testing

To determine the product or service quality we use the GLP process. It involves carrying out an open-ended study that aims to obtain reliable and complete results. The main criteria of GMP are that the products manufactured require meeting the standard guidelines and set.

5. Facility

For the facility, the GLP GMP requirements specify the type of testing that should be conducted. And what design and construction of the facility should be suitable for the different types of testing. The facility should also have the necessary separation areas to prevent contamination and mix-ups.

6. Equipment

GLP ensures that the equipment is properly maintained and can be used for its intended purpose. Also, the lab uses the data to maintain integrity and accuracy of the device. In GMP, all equipment must be qualified to use in the manufacturing process.

7. Standard Operating Procedure

Qualified personnel follows these procedures as written instruction during their study. For GLP, a dedicated person records the methods and objectives and separately conducts every study. Thes records require approval by the study director. However, GMP requires study-specific protocols.

8. APA System

,The CAPA system isn’t require in the GLP regulations, whereas, in the GMP, it is necessary.

9. Master Schedule

Quality Assurance keeps a log of all studies conducted in accordance with GLP.  There is no such requirement for GMP.

10. Records and Reports

The GLP standard applies to the keeping of record. This is related to the preparation and procedures.  The manufacturers uses these records  for the product approval. They need to keep these records for at least two years and if they sell these products they have to keep records for up to five years. But the requirement is different for GMP.

In GMP, records should have signatures of all the staff and supervisors. And the manufacturer should maintain the records for a minimum of one year after the product expiration.

The Final Takeaway

The evolution of technology and the regulations governing the approval of medical products are creating new challenges for manufacturers. As a result, they are looking for ways to improve processes and minimize risks. Artificial Intelligence (AI) and other technologies on GMP and GLP in the laboratories are likely to grow.

Both GLP and GMP are the regulations that the FDA enforces. FDA uses this regulation to ensure the quality of the products.

Well-known contract laboratories support the use of quality systems that ensure consistency, quality and uniformity. These trusted labs are one of the best ways to learn about your needs and understand your goals.

Frida Stewart

About Frida Stewart

My name is Frida Stewart and I'm a writer, a blogger, and a communications expert. I have many years of experience producing and curating content for the digital space.

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