Good Laboratory Practices (GLP) Certification Program Can Help

The U.S. Food and Drug Administration oversees the development and manufacturing of medicines and drugs that can be used to treat diseases and other healthcare issues in humans. The agency also creates, amends, and updates the rules and regulations that manufacturers of medicines must follow when conducting tests to innovate new drugs. These rules are included in the Current Good Laboratory Practices (GLP) and Current Good Manufacturing Practices (cGMP) dockets. If you’re the owner of a company producing medicines, you must get your GLP certification to assure buyers and users of the drugs that the procedures adopted by your laboratories comply with the regulations laid down by the FDA.

Understanding the Good Laboratory Practices Program

Should you sign up for the Good Laboratory Practices Certification program, you will learn how to ensure that the labs maintain a uniform and consistent method for researching and testing medicines. You’ll also make sure that the results are reliable and can be recreated. Further, ensuring that the end products are high-grade and all non-clinical safety measures have been followed is also included in the program.

You may also be required to evaluate the physio-chemical properties of the drugs by running them through toxicity tests. Interestingly, as this document released by the EPA clearly indicates, the regulations of the GLP are closely interlinked with the rules laid down by the EPA with regard to the possible environmental impact of the drugs.

How the Good Laboratory Practices Program Progresses

1. Reliable and esteemed training programs like the CfPIE assist your company with more than just training courses for the personnel working in the facilities. They also undertake inspections of your laboratories, the quality-control practices you have in place, and how you maintain records of all operations.

How the Good Laboratory Practices Program Progresses

1. Reliable and esteemed training programs like the CfPIE assist your company with more than just training courses for the personnel working in the facilities. They also undertake inspections of your laboratories, the quality-control practices you have in place, and how you maintain records of all operations.

2. Once the audit is complete, the CfPIE checks for the quality assurance practices the facility has, the methods they use to make sure that the data collected is accurate, and how these procedures are managed.

3. Based on their findings, personnel from the CfPIE will conduct a detailed discussion to explore the areas that need upgrading to comply with the FDA mandates. You may also receive a detailed step-by-step plan that you can implement.

4. Once you make the changes in your labs according to the CfPIE recommendations, they may conduct a second round of inspections to check for any additional improvements you may need to institute.

5. If the CfPIE inspectors are satisfied by the status of your laboratories and manufacturing processes, they will issue the necessary certification.

6. Typically, repeat inspections are conducted on an annual basis to ensure that your company is operating according to FDA regulations.

Having received the GLP certification, you will be able to display the seal as proof that your company is compliant with FDA requirements. Your website and products can carry this seal of approval as validation that your company is genuine.

How to Get Training in the Good Laboratory Practices Program

If you wish to acquire the GLP certification as an individual professional, the Chron magazine explains that you must take three core training courses along with one elective course. Once your training is complete, you’ll take the relevant tests according to the specific field where you’re training.

The core training courses include:

* Following the best laboratory methodology
* Creating records of the processes
* Managing the clinical trials when they are conducted

Typically, professionals signing up for the Good Laboratory Practices certification also opt to get the Good Manufacturing Practices (GMP) certification. The GMP has 6 core training courses of which you can choose any three. Similar to the GLP, you must take an additional elective course depending on the specific area where you intend to pursue a career.

While there are no restrictions pertaining to the time frame within which you must complete the courses, the CfPIE advises that you complete the courses and get your certification within a span of 3 years. That’s because FDA regulations and industry standards evolve quickly to keep pace with the advancements in the medical sphere. Each course takes around two to three days to complete. As for the location, you can choose to take the courses at various academies across the world within and out of the USA.

Having completed the courses, you must take tests under supervision. If you can acquire 70% or higher on the tests, you’ll qualify for the certification. Next, send the test to the CfPIE so they can verify it. Use channels such as fax, email, or regular mail. On receiving the certificate, make a couple of copies in case you need to submit it for further qualifications or to apply for a job posting.

Working as a GLP Inspector

Once you acquire the necessary certification, you can also work as a GLP inspector to check facilities and laboratories to make sure that they are functioning according to the requirements of the FDA. Here are some of the typical duties you could be expected to perform according to this pdf on Research Gate:

1. Check the credentials of the medical personnel who conducted the research and developed the medicine.
2. Check to find out how the research was carried out and the processes that were used.
3. Identify any issues in following the standardized protocols.
4. Understand the steps taken to resolve the issues and make sure they have been successful.

In addition to checking the actual procedures followed by the research labs, you may also be required to inspect their structures to ensure that they maintain proper segregation of different work stations designated to perform specific tasks. Maintenance of proper hygiene, optimum use of the available resources, and prevention of contamination from accidental mixing are all part of the duties of the GLP professional.

Your training and certification as a GLP professional equip you to make sure that the facility you own or work in functions in compliance with the regulations of the FDA and that the medicines and drugs are developed using safe means that also protect the environment.

Thanks to Saroj