The importance of Good Manufacturing Practices (GMP) in the pharma industry cannot be over-estimated. GMP ensures that mistakes do not occur during production, improving the health of patients, benefiting the pharma industry and health professionals, and guaranteeing manufacturers’ reputations while reducing the risk of batch recalls or costly fines. In this exclusive interview with Contract Pharma, Bryan O’Donnell, head of quality at Gaelic Laboratories—a contract manufacturing organization (CMO) with newly equipped facilities for Beta-Lactam manufacturing and packaging services—shares his advice on navigating the key considerations for GMP, based on his own recent experiences helping to set up this high-tech CMO.

Contract Pharma: When we talk about GMP in pharma, what are we talking about and how does it differ from GMP in other sectors?

Bryan O’Donnell: In any manufacturing sector, GMP ensures that products are consistently produced and controlled according to quality standards. It covers all aspects of production, from raw materials, premises and equipment, to the training and personal hygiene of staff. Sometimes referred to as the 5Ps, the main components of any GMP  strategy are Products, Processes, Procedures, Premises and People.         

Specifically in the pharma industry, GMP strategies provide a system of processes, procedures, and documentation to ensure the pharma product has the correct identity, strength, composition, quality and purity. These are regulatory requirements that all pharma manufacturers must follow to ensure their products are consistently high in quality, from batch to batch. It implies a constant commitment to the highest available quality standards through the use and correct maintenance of up-to-date systems and technologies.

CP: Let’s focus first on that equipment maintenance—people talk about a “risk-based maintenance approach”—what is this and how do you implement it?

Bryan: It goes without saying that pharma plants have vast quantities of equipment. Imagine a scenario in which every piece is treated equally in terms of maintenance. That might seem like a good idea, to simply maintain everything in regular rotation, but in fact some equipment poses a higher risk if it goes wrong. You might want to pay particular attention to those machines, giving them a little bit of extra regular attention rather than waiting for them to come round in the maintenance rotation.

For example, you’re going to have some pieces of equipment that would directly impact the production, quality or safety of the drug product if they were to fail. That might be your autoclave, your purified water system or your mixing vessel. These types of equipment need constant checking, and a critical spare parts list is a good idea. Other equipment has no impact on product quality or the safety of your environment—perhaps a lifting device, or a conveyer belt in the warehouse. Clearly, it would be better if neither of those machines failed, and good maintenance is required to avoid that, but you are unlikely to have to dispose of an entire day’s production, or get fined by the EMA, if your warehouse conveyer belt is faulty.

By categorizing your equipment like this, you can develop a plan for appropriate maintenance. For example, autoclave temperature monitors might need to be checked and calibrated every two or three months, whilst your temperature monitor in the warehouse might only need checking once a year. By compiling a list of all existing equipment, categorizing it by risk, and using those categories to develop a sensible and proactive maintenance plan, you are far less likely to have to deal with maintenance emergencies at your plant. 

CP: So, you develop a plan based on your existing equipment, but Gaelic Labs has recently upgraded most of its manufacturing equipment—how does this impact your maintenance plans?

Bryan: Well, we’ve had a huge amount of investment over the past two years, and you’re right, we have been very fortunate in that it’s allowed us to build on our technologies and competencies. We’ve managed to improve and expand our technology base for Beta-Lactam manufacturing to meet the most up-to-date standards.

You’re also right when you highlight this as an opportunity to refine and update maintenance plans. We’re fortunate enough to have a tremendously experienced team—Gaelic Laboratories might be only 2 years old, but we are based on a site that has been making generic medicines to FDA standards for about 40 years, so we were in the unusual position of being able to start a new company with an existing heritage of excellence, and an established extensive knowledge base.

We would never choose new equipment without first consulting our maintenance department, our manufacturing engineers and our development experts. Taking all these different viewpoints into consideration, we can be confident that any new equipment we purchase will complement all our other machinery and tools, and we can have sensible discussions about risk categorization and keep our maintenance plans fully up to date.

CP: How much training does your manufacturing team need to ensure GMP compliance?

Bryan: Every member of our team is properly trained to comply with GMP. Whether in the testing laboratory or in the manufacturing plant itself, we are committed to ensuring our people are properly prepared for the pharma manufacturing environment.

As I said before, we are fortunate enough to have a tremendously experienced team, but we are also recruiting at the moment—Gaelic Laboratories is going through an exciting period of growth, and we are investing in building our workforce. For each new hire, we initiate GMP training to make sure they are aware of all relevant regulations and requirements. This includes a whole range of things, from making sure they are aware when QA needs to be involved, to making sure plant workers are aware of the effect of changing a setting on production equipment.

CP: How is product quality assurance performed?

Bryan: This is a pretty extensive area, covering everything that ensures processes and procedures are output safe, and that the drug product is compliant with regulatory standards. We see QA as distinct from QC, although both strategies are obviously complementary. Generally speaking though, regulators tend to focus more on QA, so we place a huge amount of effort in proactive, assurance-based activities that prevent quality issues arising in the first place.


Pharma QA touches every phase of the product lifecycle, and the planning, system governance and process of every phase of our business. Our QA professionals are responsible for defining and executing systems and processes across the company to ensure our Beta-Lactam products and services meet all quality, efficacy and safety requirements. This means performing process validation at each step, so we can control what’s happening throughout the production of the drug product.

For example, before we buy any raw materials or containers, QA verifies that every provider in our supply chain is operating under the same stringent processes as us. QA will help verify that the drug creation process is designed correctly and that everyone involved is aware of their role in that process. If we identify a problem, our team will work to determine the source and they’ll address it quickly to keep production moving, and to make sure our products are as safe and effective as possible.

We are on a site that has been consistently manufacturing the highest-quality pharmaceuticals for about 40 years. That kind of record can only be achieved with great QA (and QC) and with a culture of continuous improvement that allows us to regularly assess our systems, find the flaws, and build a plan for correcting them. We identify quality issues before they impact our products, and this gives us ways to reduce costs and increase production.

CP: Does “smart manufacturing” play a role?

Bryan: The digitization of manufacturing is now picking up speed and it would be crazy not to realize the benefits: higher quality products, produced more efficiently, more “in-spec” and more economically, with better process safety. Added to this, regulatory demands for greater consistency, better traceability, improved safety and reduced waste can all be met through the application of smart pharma manufacturing.

From start to finish, smart manufacturing can reduce risk by, for example, checking the quality of incoming ingredients, enabling companies to see and proactively address process drifts, improve production performance, and ease the burden and cost of regulatory compliance. The real-time aspect of these insights is particularly crucial in the pharma industry—you really want to know if anything is wrong with your product before it ends up in distribution! Smart manufacturing can offer insights into processes, help operators and engineers better understand what is happening in their plants, and address any deviations as soon as they arise, before they cause real problems. Like most companies in this industry, this is something that we are currently driving forward with.

CP: How do you ensure your documentation is ready for audit? 

Bryan: Detailed written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process—every time a product is made.

If you keep your documents on a wireless tablet PC, you can always have them readily to hand and you have the added bonus of being able to get them checked electronically. We assign someone to take responsibility for each set of documents, to make sure they are always up to date and available.

The auditors who know that maintenance is a GMP risk will also ask for documentation describing equipment maintenance, and when and how that maintenance has been done. Our team is trained to make sure we always have that documentation, and that it’s followed closely.  We keep it simple, and we make sure our teams can provide any necessary evidence to the auditor if they need to.

We have found that, typically, an auditor asks for maintenance records for a few product-critical items. If our records say, “Preventative maintenance carried out according to manufacturer guidelines,” and we can quickly offer copies of those guidelines, that ready availability of supporting documentation can be more convincing than anything else.