The US-based pharmaceutical manufacturing expert sets the record straight on quality assurance. “Quality is of utmost priority, and top-level management must understand this. We must teach GMPs to them,” she says
US-based GMP consultant Joy McElroy
Google her name and the first results you’re going to get from Joy McElroy are of her articles, training and presentations on GMP compliance. McElroy has 27 years’ experience in the pharmaceutical industry and has mastered the in’s and out’s of quality assurance, equipment qualification and process validation through roles at Kabi Pharmacia (now Pharmacia and Upjohn), Abbott Laboratories, and pharmaceutical giants Wyeth Lederle and Mallinckrodt.
In 2013, the entrepreneurial spirit kicked in and saw her launching a consultancy firm with business partner Vernal Maynard. So, when she tells me that over the years she has seen the industry become somewhat desensitised to true quality, the conversation just gets better and better.
“I have seen approaches to process validation and equipment qualifications become short-skirted,” she says, arguing that companies want to short cut around the traditional qualification and validation methods just to get manufacturing up and running.
“Fortunately, however, I think lately, with more FDA consciousness, the ISO regulations and updates on the EU guidance, there has been a shift to more ongoing observations and considerations to implementing quality,” she explains.
Today, she is at the helm of her own company, McElroy Training and Consultancy, and her home in North Carolina, just a few minutes east of Raleigh, in the United States, is the headquarter of her business. McElroy employs 20 consultants who are currently working on various projects across the country and Canada, running the gamut of equipment qualification, cleaning validation, engineering, quality control and quality assurance on top of training to companies in these areas. Her client base includes Catalent, Bio Vectra, and Imprimis, to name but a few.
Pharmaceuticals were not on her radar for a professional career. She majored in Zoology at the University of North Carolina before hoping to get into a vet school. It was the job she got at Kabi that sparked her interest in the making of medicines. “I thought it was great to work in an industry that provided healing medicines to people all over the world,” she tells me. “I felt as if what we were doing was making an impact and helping people.”
At Kabi, McElroy worked as a quality control analyst and there was where she received her first GMP training. “I truly believe it was my first experience at Kabi that gives me insight still today,” she tells me. “I had great people [there] that taught me the foundation of quality control and quality assurance. [They] instilled a great quality work ethic in me,” she adds.
SOPs must be written so well that anyone foreign to the plant can come in, read an SOP and know exactly how to perform that job
McElroy tells me the atmosphere at that Kabi plant was all about manufacturing a quality product. “The person that stood out to me the most was the documentation specialist,” she explains. “She conducted annual GMP training and documentation training and was very serious about her job. She taught me that SOPs must be written so well that anyone foreign to the plant can come in, read an SOP and know exactly how to perform that job. That has stuck with me ever since. She understood the impact we have on people’s lives every day, and she wanted to make sure we understood that as well,” she tells me.
At Abbott, McElroy learnt about training and instilling a quality work ethic in young people. Working at the EM laboratory, her role included supervising new staff who had joined the company just out of college. Beyond the people’s management experience, Abbot was McElroy’s first exposure to aseptic manufacturing.
McElroy is adamant about quality and is in no doubt the pharmaceutical industry has not done the best job of instilling a quality atmosphere from the very top management down to the manufacturing floor. “Quality is of utmost priority, and top-level management must understand this. We must teach GMPs to them,” she says.
McElroy believes managers must understand their jobs are not just about the money and budget. “They are the ones responsible for demonstrating quality to their employees,” she says. For McElroy, companies cannot have quality control and manufacturing teams as the only ones interested in quality. It must be a total plant-wide consciousness.
Quality is of utmost priority, and top-level management must understand this. We must teach GMPs to them
From the business perspective, McElroy understands that research is driving demand for medicines, which is the reason quality is paramount. “Research is providing the development of immunotherapy drugs and new chemotherapy drugs that are less harmful and great at treating cancers and other diseases,” she tells me, and I learnt that for McElroy, making quality oncology drugs has just gained a whole new meaning. She recently received an alarming diagnosis for breast cancer, but the prognosis is good.
“Thankfully caught in time,” she tells me. “It is a chapter in my life that I am honestly thankful to be in. I’m learning so much, and this journey is contributing greatly to my speaking, adding to my ability to impact the world with my story of survival.”
Since 2018, McElroy has been travelling the US hosting empowerment talks at churches and schools. She believes gratitude is the feeling that leads to empowerment and that this applies to all aspects of life, and more so to those working in the pharmaceutical industry. She explains: “If we cultivate a grateful mindset for all things, then we take nothing for granted. We appreciate all that we have no matter how small or large. When we are grateful, we begin to realise our purpose. We understand that even the smallest things make a difference in people’s lives.”
For McElroy, making a difference in peoples’ lives through our jobs, through random conversations, or through simply smiling and saying thanks is empowering. "The biggest thing we can do in this life is to impact others positively," she points out. "We impact others through all that we do. As we do this, we find our passion and we begin to work on that passion and to impact more people with our services. Impacting change through service and gratitude makes all the difference, the money will come. If we are grateful, our jobs have meaning, and purpose and we want to make a difference by producing a quality product that will save a life,” she says.
McElroy's home in North Carolina, just a few minutes east of Raleigh, in the US, is the headquarter of her business
Joy McElroy names equipment qualification, both manufacturing and analytical equipment, as the most common issues she sees in companies that lead to GMP and quality failures. “Companies do not want to perform performance qualifications (PQs). They will perform installation qualification (IQs), and operation qualification (OPs), but not PQs. They feel it is not necessary. They get cited on this all the time by the FDA. Both OQ and PQ are required by the GMPs,” she tells me, and the quick-fire questions begin.
Why OQs are so important?
Operational qualifications are run to test the critical operating parameters as set forth by the manufacturer. You want to show that the equipment is running and meeting the operational requirement it was designed to meet. Performance qualification is run to show that the equipment will meet specific parameters for its everyday use. Both qualifications show reliability, consistency, and repeatability in the operation and everyday performance of the equipment to manufacture a product the same each time without variability.
Why do you think PQs are being overlooked?
It’s part of the short cutting and not wanting to take the time to qualify because of the desire to get the product made and on the market for sale. It all has to do with money, therefore quality must be instilled in upper management so that they understand the importance of implementing GMPs correctly to manufacture a quality product.
What role does training and facility design play?
Training personnel is the largest role. We must teach our employees that what we do each day may be life or death to someone. We must develop sound ridged training programmes and continuously monitor employees to ensure SOPs are followed and training is up to date.
Do you think companies see training personnel as a hurdle or a need?
I think they see it as a hurdle in some ways. Again, it goes back to time and money. Companies want to train personnel in the fastest, easiest way to get them working to manufacture a product and to get it out the door.
What is your advice to companies?
Depending on the job, companies should have a training programme where the employee reads the SOP, watches the job being performed, performs the job with the trainer, then performs the job alone while being observed, then takes a quiz and is qualified. All must be documented and kept on file in the employee’s records. If a procedure changes, it must be mandatory for the employee to read the procedure over again, and depending upon the criticality of the change, go through the same or partial process.
What is the good, the bad and the ugly of process validation?
The good is that it provides documented evidence that a process is repeatable, reliable, and consistent. The bad is that it takes time, money and training to carry out a process validation properly. The ugly is that it is not always carried out properly or the process is never revalidated.
McElroy tells me that just as with any validation or qualification, companies must have requalification and revalidation programmes. “We must understand that critical processes and critical equipment must be requalified and revalidated yearly, and other processes and equipment requalified and revalidated at least every three to five years,” she says. “We cannot let a process or equipment run for 10 or 15 years and never show documented evidence it is still running as it supposed to,” McElroy concludes.
N.B. This article is featured in the October 2019 issue of Cleanroom Technology. Subscribe today and get your print copy!
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