I almost wrote this article anonymously. Because what if my colleagues see it? Will I be shunned?
Not long ago, a counterpart in the contract pharmaceutical manufacturing industry told me he wouldn’t follow any GMPs if he didn’t have to, and I was shocked by his stance. Really? I thought. Being an engineer, I think GMPs make sense –business sense – to the extent that even if regulators didn’t require GMPs, I would follow the practices anyway.
Since beginning my career in pharmaceutical manufacturing, I have been only too aware of the begrudging way people look at GMPs. The general consensus seems to be that GMPs only add cost to the manufacturing process.
But do they really? And what processes would we skip if we could?
When I think about these questions, I look to other businesses that are successful but not regulated in the same way pharmaceuticals are.
One that comes to mind is UPS. Early in my career, I was a project engineer working on-site in the main UPS sorting facility in downtown Los Angeles. The days were extremely quiet with the facility virtually empty, but when I showed up at four in the morning, it was a whole different ball game.
The facility looked, felt and sounded like absolute chaos, with tens of thousands of packages moving through on every type of conveyor possible. It seemed like it would take weeks to sort out, but by 7 a.m., without fail, the facility was empty and every package was on a truck, headed to its destination.
I was fascinated by that process that – despite all chaotic appearances – was highly organized and highly efficient with back-up plans to back-up plans.
Despite the different products involved – packages versus medications – UPS does many of the same things we do in pharmaceutical manufacturing: Hire the right people, develop the right facilities, and extensively test the necessary equipment and production and process controls.
I love this stuff.
Take, for example, the validation of equipment, one of our GMPs. When wouldn’t you want to do that? Is it more expensive to test a piece of equipment before you have expensive product running on it or while you’re in the middle of a time-crunched production run, trying to satisfy a client?
It’s always cheaper before. Why on earth would anyone buy a costly and critical piece of equipment and then not test it to the nth degree before exposing it to costly and critical product?
The other lesson I learned from those early mornings in the UPS facility was the importance of a work culture that values continuous process improvement.
One day in the UPS facility, at about 7:01 a.m., I spotted a lone package on the dock. Suddenly, a swarm of people huddled around it – more people than I had ever seen in one place at one time in that facility. A package had not gotten on a truck, and you would have thought that 10 broken-down trucks carrying thousands of packages could not cause as much consternation as did that one package.
But the orphan package signified a breakdown of the process – it was a red flag that something in the system went wrong. So it was serious. It was an indicator for continuous process improvement.
Yes, regulators have set clear expectations for those of us in pharmaceutical manufacturing about calibrating and validating equipment; maintaining clean facilities; training qualified employees; and demonstrating that our processes are reliable and reproducible, and that our validation methods have been tested and re-tested.
But even if those expectations weren’t regulated, GMP is simply good business practice. We need to know what we are doing, how we are doing it, be able to document it, and then figure out how to make it all better. This is what any good businessperson does to keep the enterprise running smoothly and in the most profitable way possible. So in response to my fair colleague, who would abandon GMP if possible, I must humbly disagree.
About the Author
As director of manufacturing at OsoBio, Catherine R. Buck ensures that the company’s operations comply with current Good Manufacturing Practices (cGMP) in the manufacturing of injectable sterile liquid, suspension and lyophilized pharmaceutical products. In addition, she ensures compliance with appropriate FDA and DEA regulations, and directs manufacturing activities to ensure timely, cost-effective and efficient production.
With more than 20 years of leadership and project management experience in the pharmaceutical, medical device and construction industries, Buck has managed multiple commercial and clinical pharmaceutical manufacturing plants generating $2.5 billion-plus annually.
OsoBio – OSO BioPharmaceuticals Manufacturing LLC – is a CMO that delivers injectable sterile liquid, suspension and lyophilized biologic and pharmaceutical products to the pharmaceutical industry. The company offers significant knowledge and experience in late-phase clinical products and taking them to commercialization.