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The Science of GMP: Dr. Kamal Dua on Pharma & Compliance

Interview | February 3, 2025

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Dr. Kamal Dua discusses his transition from the pharma industry in India to academia at UTS, Australia, and insights on GMP practices.

Pharma Now: Welcome to Pharma Now, Dr. Kamal Dua. We are honoured to have you, and we’re excited to learn more about your educational and professional background and your role in GMP practices. Can you tell us about your journey to becoming an Associate Professor at the University of Technology in Sydney (UTS), Australia?


Dr. Dua: I am an Aussie-Indian. I grew up in India. I earned my undergraduate degree in pharmaceutical sciences and my post-graduate degree in pharmacy with a specialization in pharmaceutics, which is also very industry-driven. Then, I started working in the Indian industry. I always had a passion for academia, and this passion took me towards universities and academics.

I completed my PhD from a public university in India. Then, I applied and was accepted for an academic position in Malaysia at the International Medical University in the Department of Pharmaceutical Technology. This position was the first step in working for an international education system. From there, I got multiple opportunities.

While I was researching and working in the industry, I felt that many biological aspects were lacking in current research. That’s why I pursued a second doctoral in immunology and microbiology from the University of Newcastle, Australia. After completing my second PhD, I got a continuing position with the UTS, where I'm currently an Associate Professor in the Discipline of Pharmacy, and I’m leading most of the pharmaceutical science subjects.

I'm also a program coordinator for a very niche program offered by only the University of Technology in the Asia-Pacific region. The program is called Good Manufacturing Practices (GMPs). Everyone knows that the basic principles and practices of GMPs are applicable in many industries. Pharmaceuticals, medical devices, biotechnology, food, dairy, and meat industries–all follow GMP principles and procedures.

The GMP program is very niche because it is established at the UTS with our industry partner, C Pharma, which is a big Vitoria-based consultancy company that offers consultancy services to major Asia Pacific Industries. The program has three levels: a graduate certificate, a graduate diploma, and Masters in GMP. The Masters course is two years, the graduate diploma course is one year, and a graduate certificate is a 6-month program. Approximately 60% of the enrollment is from international students, and the remaining 40% are students from Australia and New Zealand. Most students who complete the Master’s degree are absorbed by the multiple industries in Sydney or other Australian cities.


Pharma Now: I haven’t come across such a niche program, and I’m sure it’ll help aspirants gain in-depth knowledge about GMPs. Because you’re the program coordinator, I’m sure you know everything there is to know about GMPs. Our magazine is read by many students earning degrees in pharmaceutical sciences. They may not know much about GMPs. Can you explain what GMPs are, and why they should learn more about these from an industry perspective?


Dr. Dua: Yes, of course. I usually explain the GMP rules using the show My Kitchen Rules. I’m not sure how many people know about the show. It’s simply how you normally cook food in your kitchen and how efficiently you cook while maintaining quality standards. When I say ‘quality’, it also includes the product’s safety and efficacy. If the quality, safety and efficacy of your product are retained and you can reproduce the quality, safety and efficacy of the product using a standard method, that is your good manufacturing practice.

This practice is not restricted to manufacturing. It can be related to your quality control, quality assurance, and even regulatory affairs. How beautifully you do your work and how passionately you improve it every time drives your GMPs. 


Pharma Now: Are GMPs very different from other quality assurance practices and standards?

 

Dr. Dua: There are many different standards. Currently, good laboratory practices (GLPs) are becoming popular, and even current GMP (cGMP) are popular. GxP, which stands for "Good x Practice”, has multiple terminologies. But, these practices and terminologies are aimed at maintaining the standards, quality, efficacy, and robustness of your product development process. 


Pharma Now: So, what is the key documentation required for GMP compliance?


Dr. Dua: The key documentation varies from one area of the industry to another. For example, in the production of parenterals, the manufacturing of a sterile injectable product happens in a very controlled facility where certain grades have to be maintained. So, how you enter into that facility is one of the main criteria that is documented, and it becomes a part of the GMP. Manufacturing, quality control, and product checking are all included in GMP. Hence, manufacturing has its own aspects. 

In quality control, you have to test the formulation to determine whether it has the desired quality, drug content, purity, and safety in animals. Hence, there is a standard procedure. When the next time the batch is manufactured, it needs to be reproducible using the same method. So, this is what you document, and that's called GLP. We use a master control file or a document control file. Different Industries have different terminologies. Different regulatory bodies use different terminologies. So, it varies.


Pharma Now: As you mentioned, GMP plays an important role in quality control. While implementing GMP in quality control, what do you need to keep in mind?


Dr. Dua: In quality control as a sector, you should always try to refer to standard procedures from pharmacopoeia. For example, if I perform a quality control test for paracetamol, to test the drug for impurities or for assay method development, I need to refer to a certain pharmacopoeia, such as Indian, U.S. or British Pharmacopoeia.

I need to make sure that the procedure I'm following is well documented. I have to sign the document stating the exact procedure used, and another person who can verify the document should also sign it. If the regulatory body visits the facility for inspection, we have to provide evidence.This document validates that I’ve followed a standard method from the pharmacopoeia and was endorsed by another person before it was practised for the same product multiple times. 

The second important thing in quality control is equipment calibration. I have to maintain a standard record of equipment calibrations and parameters. I’ve to present it if asked by an inspector. This is what GMPs are about for quality control.


Pharma Now: When we talk about GMP, at what level should manufacturing and quality control go hand in hand and what all compliances need to be followed? 


Dr. Dua: It is very much like a symmetrical circular fashion, which starts with the entry of your raw materials into a warehouse where the testing of the pure samples initiates and then moving to the manufacturing area and following all those GMP protocols back to the quality control and quality assurance and coming to the market and that loop again starts when the batch runs out and another batch is initiated so it is a very hand-to-hand practice and it is a harmonized practice across the different departments or different areas in the pharmaceutical industry.


Pharma Now: You mentioned that there are different pharmacopoeia that companies can offlow. How do regulatory authorities ensure the practices are followed?


Dr. Dua: For example, European requirements are very different from Australian requirements. Sometimes, European agencies visit Australian facilities to ensure they’re following the necessary standards. Hence, it's not necessarily important to stick to the requirements of that particular geographical location. You also need to ensure that it meets the criteria of other locations. If you're sending our products to India and other countries, you need to make sure the products comply with all regulations. 

Regulatory bodies can inspect facilities to ensure all processes are followed as per their regulations, which can provide easy access to the market even if the product is made in a different geographical location. The temperature requirements are the best example. So, the weather is very different in Europe and Asia. The manufacturing of a product can be done at a particular location in Asia. But when that product is transported to Europe, manufacturers have to make sure it maintains its stability profile, purity, therapeutic effectiveness, and quality. To achieve that, they follow certain guidelines. For example, the International Conference of Harmonization (ICH) guidelines. 


Pharma Now: Of course. As you’ve mentioned, these standards are implemented from the very bottom of the operational chain. Hence, students should be prepared to follow these guidelines once they enter the industry. Your program on GMPs is focused on such standards. In it, how do you groom students? 


Dr. Dua: I'm the program coordinator for the GMP program in the Asia-Pacific region. This program embeds basic pharmaceutical sciences and is designed in such a way that from day zero, students learn about the foundation of GMPs. The course includes a subject called International GMP and quality assurance. This subject covers all important guidelines from different countries and how they've been embedded in operations. 

In addition to GMPs, students are also trained in niche areas that are becoming popular in the pharmaceutical industry. For example, the use of artificial intelligence in the pharma industry is rapidly growing. So, we teach validation principles and practices. We have core subjects in that area because we recently went through COVID. Biotech industries are booming. So, we have a new subject on biotech manufacturing, where students learn how to produce biopharmaceutical products. 

Medical devices were never considered in previous courses. Now, their regulations are as strict as those for other pharmaceutical products. Medical devices need to be thoroughly tested before they get to the market. We have a whole subject on the stability of medical devices. We also have a full subject on stability, quality, and contamination control, which is a whole area in sterile product manufacturing.

There are different aspects, and the program is taught to students so that they get in-depth information that is needed in the current growing and demanding industry. 

The best aspect of this program is the two industry research projects in the second year, during which the student actually performs those projects in a company. The feedback that I have gained from industries most of the time is, “We would like to employ your students because we have given them one year in our company to do a project, and they have learned all the important aspects of our company. So, we would really like to offer them a job”. Hence, these are just some parts of the program from an academic side that are really important to learn, like how industry-driven and niche it is.  


Pharma Now: Excellent. I think this is an excellent program that students should consider for their future growth. What key message do you have for students aspiring to make a career in this field?


Dr. Dua: Every student has their journey. Everyone joins the first year of a pharmacy thinking that they're going to be a pharmacist. But, at the end of the day, that's not the end of the journey. A pharmacist can be a hospital pharmacist, a community pharmacist, or switch to academia. There also a lot of scope in research, but we're talking about GMP here.

There are so many programs across India. For example, Master's in quality assurance and quality control, Master's in analytical techniques, and others. But if you really need all these things under one umbrella, which is GMP, ours is an excellent course. You really need to think of how you can use that education in your career and grow your career. The best example is regulatory affairs. You start as a Regulatory Affairs Coordinator, then become a Regulatory Affairs Associate, and then a Regulatory Affairs Manager, managing the whole industry and registering your projects to sell them across the globe. So, I wish all students good luck in their future.


Pharma Now: Excellent, thank you for joining us at Pharma Now, Dr. Dua.

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