Is there a one-size-fits-all approach to qualification and validation?

Not every machine needs to be qualified in exactly the same way.

When it comes to qualification and validation, it can be tempting to follow a familiar process and apply the same level of scrutiny to every piece of equipment. But in practice, that approach doesn't always make sense. The right level of qualification depends on what the machine does, how it is used, and ultimately, the product it is being used to manufacture.

We spoke to Quality Engineer Amy Pilkington about why qualification shouldn't be a one-size-fits-all exercise, how the V-model provides a consistent framework, and why a risk-based approach is essential when determining how much qualification is really needed.

What is the standard approach to qualification?

The qualification (or validation) of machines generally follows the V-model. The V-model maps the user requirements for a piece of equipment through the design and development process, before testing whether those requirements have ultimately been met. It provides a well-established framework for activities such as Design Qualification (DQ), Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ). But while the framework is consistent, the level of qualification required within it can vary considerably.

Why don’t all customers treat FAT, SAT, IQ and OQ the same?
Not all our customers approach qualification and validation the same way. The level of scrutiny applied at FAT, SAT, IQ and OQ is driven by the legal and regulatory exposure tied to the product being manufactured. A non‑consumable FMCG line may only need verification that equipment is designed and built correctly (commercial risk management). An aseptically prepared parenteral drug product must demonstrate, with objective evidence, that equipment is correctly specified, operates correctly and remains in control.

So, is there actually one standard approach?

Not really. Many descriptions of pharmaceutical qualification and validation can give the impression that there is one fixed methodology: complete the required stages, produce the documentation and demonstrate that the equipment works. In practice, there is a much wider spectrum. The appropriate level of qualification depends heavily on what the equipment is manufacturing and what the consequences of failure could be for our clients.

What does that spectrum look like?

At one end, you might have equipment where failure represents primarily a commercial risk for our customers. For example, if a machine manufacturing a non-critical product fails, the consequences could be lost production, rejected product or customer dissatisfaction. Qualification still needs to demonstrate that the equipment has been designed and built correctly and operates to the agreed specification. But there may be little value in applying an extremely complex validation programme. 

At the other end of the spectrum are pharmaceutical manufacturing processes where equipment failure or contamination could potentially result in serious consequences. Here, qualification and validation must be much more detailed and rigorous. Between those two extremes is a wide range of applications, including medical devices and pharmaceutical products manufactured for research and development purposes. 

Does the level of risk always relate to the product itself?

Not entirely. The risk profile is really a combination of several factors. It can depend on:

• The product being manufactured
• How the product is manufactured
• The intended use of the product
• The controls within the manufacturing process
• Whether a failure can be detected downstream
• The potential consequences of that failure

Two machines could therefore manufacture pharmaceutical products but require very different approaches to qualification depending on their specific applications.

What happens at the lower-risk end?

Where equipment failure represents a commercial or production risk primarily, the qualification process is largely about ensuring the equipment supplier has delivered what was agreed. The focus is on demonstrating that the machine is: Designed correctly. Built correctly. Supplied correctly. And fit for purpose. There may be little benefit in subjecting that equipment to the same level of scrutiny as a system where a failure could directly affect the ability to manufacture and release safe medicines. 

And what about medical devices?

Medical device manufacturing can sit somewhere in the middle of the spectrum, depending on the application. There may be a moderate risk associated with an incorrectly assembled device, meaning the equipment needs to be carefully qualified and the manufacturing process needs appropriate quality controls.

The important difference is that many of these risks are measurable and predictable. For example, components may either have been assembled correctly or they haven't. The manufacturing system can incorporate controls and inspection processes to detect that.

What about pharmaceutical manufacturing?

Pharmaceutical manufacturing can sit much further towards the high-risk end of the spectrum. Even within pharmaceutical manufacturing, however, there are different levels of risk. For example, a terminally sterilised product benefits from the additional control provided by the terminal sterilisation process.

Aseptic manufacturing presents a different challenge because the manufacturing environment itself needs to be carefully controlled to minimise the risk of contamination. The most demanding applications may involve highly sensitive products and particularly challenging cleaning, sanitisation and decontamination requirements. In these cases, the consequences of failure can be much more serious – a batch of critical product may not be released for example. 

So why not just apply the highest level of validation to everything?

Because it isn't necessarily valuable and it can be extremely expensive. In an ideal world, every piece of equipment could have an incredibly detailed qualification and validation package. But qualification and validation take time, resources and money. Applying the most rigorous possible approach to a low-risk application could create a significant amount of additional work without meaningfully reducing risk. The objective shouldn't be maximum qualification. It should be appropriate qualification.

How do you determine what is appropriate?

Start with the risk, then ask:

• What are we manufacturing?

• What happens if the equipment fails?

• Could that failure affect product quality?

• Could it ultimately the ability to release a batch? 

• What does the manufacturer's quality system require?

The answers help determine the appropriate level of qualification and validation.

Does the manufacturer's quality system already define this?

Often, yes. A customer’s  quality system will generally establish the processes and controls required to manage the risks associated with its products and manufacturing operations. That includes requirements around purchasing, installing and qualifying equipment. So rather than treating qualification as a standalone exercise, it should be considered as part of the customer’s wider quality system. 

What's the biggest misconception about qualification and validation?

That more is automatically better. Qualification should be rigorous where the risk demands it, but it doesn't need to be unnecessarily complicated. The V-model provides the framework, but the detail within that framework should reflect the application. The product and its risk profile should influence the qualification approach, not the other way around.

So, what is the takeaway?

There isn't a single qualification and validation package that is right for every machine. We apply the same fundamental methodology across projects, but the level of detail is adapted to according to the risk. For a lower-risk application, we may agree with our customers that a streamlined approach is entirely appropriate. For a high-risk pharmaceutical process, much more detailed qualification and validation may be essential. 

The question isn’t “Do we validate this machine?”, it is “What level of verification and validation is required to support our clients confirm that the equipment is designed, built and operating correctly for the intended manufacturing purpose” 

This ensures that machines can be delivered in a timely manner and with the required level of supporting documentation