How fast is too fast when we are talking about the future of medicine?

This is not a new question, but it is being asked at a time of unprecedented change and at the tipping point of a whole new generation of products starting to enter commercialization. Between Cell and Gene Therapy, mRNA vaccine technology, and the full width and breadth of other R&D efforts across the pharmaceutical and biopharmaceutical space, the drug development pipeline has grown from 11 to 21 percent since the global pandemic with no sign of slowing down.

All this is happening during a time of disruption as technology diversifies, supply chains are reinvented, the industry invents unique products with unique product lifecycles, and people with the knowhow to make all this work are at an all-time premium. Beyond the normal challenges of a tight labor and limited talent pool, the Life Sciences have an insatiable demand for new STEM-related roles, with headcount growth of as much as 20% in the United States predicted by McKinsey.

As if this were not enough pressure on an industry in transition, the manufacturing facilities of yesteryear are not equipped to create many of the new drugs, and the question of how and where to build the new facilities is open-ended with no one right answer. I have had several conversations where industry leaders have speculated one day every hospital in the world might have a device in it the size of a vending machine generates patient-specific medicine one dose at a time. If that is where pharmaceutical manufacturing or even a substantial part of pharmaceutical manufacturing is going, what are we doing right now to connect our present to that future?

Even putting to one side the more speculative possibilities, capacity is a huge challenge facing the industry right now that people have a lot to talk about. For every link I have just shared, I have more content on my forward schedule that is also talking about this critical issue.

As every company from startup to titan struggles to get what they need when they need it, it should always be kept in mind that at the end of the day all this talk of product is really about patients in need. You cannot cut corners. You cannot allow quality to slip. The whole exercise of creating medicine is moot if the end result does not work.

We have a lot of conversations about challenges and opportunities facing the Life Sciences right now. Today I want to revisit a few of the fundamentals, because there is no forward progress if we relax our firm grip on what makes the whole thing work in the first place.

GMP Now. GMP Forever.

I expect many of the people who are reading today’s article actually work in the Life Sciences, but for those who don’t, GMP stands for Good Manufacturing Practices, and cGMP stands for current Good Manufacturing Practices. While these terms are mostly interchangeable, it is worth highlighting pharmaceutical manufacturers have these two acronyms because while they are required by regulation to meet the standards set by cGMP, compliance is the starting point, not the finish line. The GMP of every business in this sector should go beyond the rules of today to exceed expectations and demonstrate a constant commitment to the highest available quality standards while documenting and demonstrating that commitment in a way that manufacturers of other products would consider daunting to the point of onerous.

The license to operate in the Life Sciences revolves around GMP, so let’s review what that entails and why companies cannot relax their standards even as they struggle to grow and build what they need for their future.

The 5 Ps of GMP

The 5 Ps of Good Manufacturing Practices are:

  1. People. If you are making medicine, you need to understand your role and your responsibilities, and your performance needs to be assessed to improve productivity, efficiency, and competency over time. The pharmaceutical sector is not like other industries that can scale up and scale down their headcount with temporary workers hired to meet peak demand working under knowledgeable supervisors. Everyone needs to strictly adhere to manufacturing processes and regulations, which means training and monitoring and an ongoing commitment to doing better.
  2. Products. When you are making something that is going to a patient, it must undergo constant quality assurance and quality control. The raw materials need to be clearly specified and carefully screened at every phase of production, and this commitment to constant testing and comparison and observation goes right through to packing and distribution. A Quality Culture demands that Quality is everyone’s business, and that means the product at every stage is everyone’s business too.
  3. Processes. All work needs to be documented in a clear and consistent way. Evaluations need to be conducted regularly to ensure the standards are being met and all employees are compliant with current process requirements. When something is proven to be the right way of doing things, deviation is not permitted. While a commitment to continuous improvement is important, that is not an invitation for improvisation. Optimization needs to be carefully planned and documented without disrupting what has already been proven to work.
  4. Procedures. A procedure is a process that must produce a consistent result. A procedure is the process that determines success or failure. If you thought processes needed to be documented and conducted in a clear and consistent way, then imagine how much more important it is that a procedure’s guidelines must be followed to the letter every time without fail. No company in the Life Sciences space gets to make up their procedures as they go along. This is not the ‘Move Fast and Break Things’ mentality championed by some Silicon Valley startups. The time to invent a procedure was years before that procedure makes something that will go to a patient. Any alteration must be reported and investigated at once.
  5. Premises. Workspaces should promote cleanliness and safety at all times. All equipment must be placed and stored properly, calibrated regularly, and proven to be fit for purpose to produce consistent results. Proactive maintenance is a must-have, not a nice-to-have. You cannot make life-saving products in an environment and with resources that you do not understand, control, and maintain, and can prove through documentation and inspection to understand, control, and maintain.

In my time before becoming an industry conference producer, I worked in several factories. I crushed rock into powder. I made gas tanks for a parts supplier for the automotive industry. I cooked steel until it crystalized such that it was hard enough to cut other steel. In all of the industrial work I did, I was never held to anything like the standards demanded of the five Ps. Most sectors do not need to be so rigorous, whereas in the Life Sciences, this is only the beginning. You have to expect more from the people who make medicine and other life-saving therapies. What they do has to work as expected every time without fail.

Five Ways to Meet and Exceed GMP Standards

Just about every company working in the Life Sciences has what it calls a Quality Culture. This is the foundation upon which all actions of the company should be built upon, but it can suffer from being difficult to define. What is a Quality Culture, and what makes one organization’s culture different from another’s? How should we connect Quality Culture to achieving excellence when it comes to GMP Standards?

Here are five things every organization in the Life Sciences space should already be doing to meet and exceed cGMP requirements:

  1. Have a Quality Team of specialized workers dedicated to improving current manufacturing procedures and complying with GMP. While Quality is everyone’s responsibility, the Quality Team is responsible for performing scheduled monitoring of instruments, equipment, processes, and staff skills. They should be the standard bearers and champions of Quality Culture. They are seeking out and identifying problems and challenges before they happen and developing corrective measures that are then incorporated into new Standard Operating Procedures. If a pharmaceutical manufacturer lives and dies by its cGMP, then its cGMP lives and dies by its Quality Team.
  2. Document everything. Validation means you can prove it. Demonstrate that you are always aware of how your processes are performing. Demonstrate that you have checked the cleanliness and sanitation of your facilities and equipment. Demonstrate that you are collecting data effectively, analyzing it correctly, and can produce results for anyone to check against. The Digital Revolution is transforming what can be documented, and it is changing the conversation around what should be documented. The amount of data that flows through a manufacturing process is more than a human being can fathom. Fortunately, we do not have to do that anymore. Almost every business working in pharmaceutical manufacturing today is automating its data collection and analysis both for compliance purposes and to speed up the turnaround between data collection, spotting something out of the ordinary, and acting on that data.
  3. Conduct surprise audits. This is not just a best practice. GMP audits are a requirement of every country’s regulations revolving around pharmaceutical manufacturing. Specifics may vary, but a good checklist should prepare your organization for the idea that an auditor may show up at any time, and so compliance is not something to be prepared for, but something you live and breathe every day with every action. This again circles back into Quality Culture.
  4. Ongoing Compliance training. While audits should not be a scary proposition, it is understandable that people fear the unknown. People who take their jobs seriously —and everyone working on medicine should be taking their jobs seriously— do not want to be caught out doing something the wrong way. Auditors should not be feared or viewed in an adversarial light. The best way to take the drama out of the situation is to educate your people about what an auditor is looking for, why what they do is important, and how people should be helping them see the SOP is being observed and the work properly documented.
  5. Have Senior Leadership set the tone. As much as GMP is in the hands of the people doing the hands-on work as monitored and assisted by the Quality Team and supported by ongoing documentation, auditing, and compliance training, if a Quality Culture is about Quality being everyone’s responsibility, that means the executives at the top need to demonstrate they know what is going on and illustrate how fundamental these practices are to everything else going on in the business. Culture comes from the top down just as much as it does from the bottom up. You want every C-Suite executive to be able to talk about Quality and Compliance fluently and reflect those values both internally and externally at all times.

We really can have whole conversations around any of these points. It is important even with everything that is happening in the Life Sciences right now to remember the day-to-day fundamentals are sound and cannot be compromised. This stuff has to work the right way every day every time. We have had conversations about regulatory complexity and what starting over with a blank sheet of paper might look like before, and we may well revisit that again. I do believe based on many conversations I have had that regulatory reform is long overdue, but it will never touch any of what we have just mentioned here.

How fast is too fast when we are talking about the future of medicine? If GMP needs to be compromised in the name of progress, that’s too fast.

No matter how fast this industry grows —and it gives every impression of being the biggest growth sector of at least the first half of the 21st Century— it can never succeed without ongoing commitment and connection to its roots.

GMP and Quality Culture are the non-negotiable unshakeable foundation upon which everything else is built.

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Geoff Micks
Head of Content & Research
Executive Platforms

Geoff joined the industry events business as a conference producer in 2010 after four years working in print media. He has researched, planned, organized, run, and contributed to more than a hundred events across North America and Europe for senior leaders, with special emphasis on the energy, mining, manufacturing, maintenance, supply chain, human resources, pharmaceutical, food and beverage, finance, and sustainability sectors. As part of his role as Head of Content & Research, Geoff hosts Executive Platforms’ bluEPrint Podcast series as well as a weekly blog focusing on issues relevant to Executive Platforms’ network of business leaders.

Geoff is the author of five works of historical fiction: Inca, Zulu, Beginning, Middle, and End. The New York Times and National Public Radio have interviewed him about his writing, and he wrote and narrated an animated short for Vice Media that appeared on HBO. He has a BA Honours with High Distinction from the University of Toronto specializing in Journalism with a Double Minor in History and Classical Studies, as well as Diploma in Journalism from Centennial College.