A 5-Step Foundation For Early CQV Involvement
By Katie Anderson, Chief Editor, Pharmaceutical Online
“[CQV] needs to be in the early parts of the process,” reiterated Bruce Klopfenstein, CQV PM for GSK, in his presentation at the 2026 ISPE Europe Annual Conference. He noted that all too often, a project’s issues show up in CQV, and it is there that blame is pointed. However, these issues start earlier and were entirely avoidable with proper planning. “CQV is just where the truth comes out,” explained Klopfenstein, going into a past story for illustration purposes.
Years ago, I was sitting in a construction trailer with the global director of engineering after a long week. We were both tired, frustrated, and staring at a mountain of problems that appeared late in the project. He looked at me and said, ‘Why does my project always go to pot when we get to CQV?’ This was a bit of a hot button for me, so I answered. This is what really happens. There are design issues/drawings with gaps and errors, but they are issued on time, everybody is happy, and it moves on. Procurement buys equipment without critical documents or service may be missing some of the spares needed for testing, but they are saving 5%, so everybody high fives and moves on. The vendor fails at FAT, but they say ‘Don’t worry, we’ll fix it on site.’ The project is still on budget and schedule, so everybody is still happy. Then construction installs all of this, and they hit MC—maybe on time, maybe a few weeks late—but they say ‘We can make it up in CQV.’ CQV shows up, and all of a sudden, the design issues matter, the missing documents matter, the failed FAT matters, and QA starts asking questions. But the truth is, CQV didn’t’ cause the problems; we are there to verify that it was installed correctly.
Klopfenstein concluded that CQV is where issues show up, but by that point, it is already too late. “What we want to be able to do is find them when we can still make a difference,” he noted. Though Klopfenstein is a huge proponent of the ISPE Baseline Guide for Commissioning and Qualification, he added that the guide assumes a foundation has been set for early CQV involvement, when this is often not reality.
Benefits of Early CQV Involvement
If CQV is not involved early in design, it becomes reactive and expensive, according to Klopfenstein. “The business case is this is going to make the whole project better,” he added.
Klopfenstein explained that early CQV is insurance for both budget and schedule, that involving CQV early in design prevents execution failure, and that it can prevent a rework.
Since Klopfenstein has seen first-hand that the foundation for CQV is often not set, he provided a five-step process to lay that foundation.
1. Program and Strategy
The first step Klopfenstein gave to lay a foundation for early CQV involvement is to assess CQV program maturity, including SOPs, templates, and governance. The qualification approach should be defined early, and as he noted, “The devil is in the details.” QA, engineering, and project management all need to be aligned before design, and they need to stay aligned. Klopfenstein furthered that the details for these C&Q SOPs should be identified early, and gaps should not be left until later.
2. System and Boundaries
The system list then needs to be set. Klopfenstein recommended to build the system list from equipment lists and piping and instrumentation diagrams (P&IDs). “Mark boundaries early, and make systems isolatable and testable,” he added. He continued that there are consequences to having bad boundaries or no boundaries, as well as waiting for final P&IDs. There are a number of methods that can be used to do a first pass system classification to drive deliverables.
3. Planning and Resources
“This is a big one here,” began Klopfenstein with his third step, which entails creating a deliverables list from the strategies and systems lists. This list is essentially everything you need to complete a CQV.
“That list is very important, and it has a lot of value to it,” added Klopfenstein. He uses AI to craft this list, and added that each system should have an owner. Once this list is created, it can be expanded with effort details such as complexity, hours and timing. Not only does this list detail all of your deliverables and how long they are going to take, but it also can be used as a timeline. It can also be replicated. “This is granular and it is a very good estimate that you can use to put together your team early. Probably one of the best tools that is in this tool kit,” explained Klopfenstein.
4. Vendors, contracts and tools
The fourth step of the foundation for improved CQV involves vendor communication and documentation. Details on Vendor Document Requirements (VDR) are included in the ISPE C&Q guide, according to Klopfenstein. He added, “I always say I need to be part of the procurement process.” He recommended embedding CQV boilerplate into POS and construction management/sub contracts.
“It is important to get these types of statements in the vendor docs, so that CQV can review documents at any point in time. This way, we don’t have to wait to get it until the end,” he explained. Without CQV involved early in vendor contracts, there could be exceptions missing in bid review, and vendors may push back later. He lets vendors know that his review of the document will be turned over quickly and added that all you need is one person to review that understands what is needed.
Klopfenstein added that validation tools should be configured early before execution begins. It is also important to get the construction management tool set up early.
“It is important that you get the contracts in place, and your vendors in place, but you get your tools set up as well during your early phase, noted Klopfenstein, who added that if tools are picked late, templates, workflows, and trainings slip.
5. Turnover Readiness
The turnover from construction to operation is a critical point for CQV to be involved. CTOP contents and document expectations as well as mechanical completion (MC) and handover must all be defined.
Klopfenstein also recommended to define CQV-OPEX transfer (TCCC) with operations early. “Makes sure this is all well documented. If you don’t have this one, it just becomes chaos trying to turn over. There are missing documents, late documents, late operations engagement, startup readiness suffers and production commitments are not met. Lobby for an operation readiness person if you don’t have that person in place,” he explained.
Early Involvement
With detailed design, Klopfenstein noted that execution runs smoothly. He concluded to engage CQV at BOD every time, insert CQV into procurement, dig into the details on strategy, and make sure everyone understands it.
He summarized, “Early CQV enables predictable CQV execution with less firefighting. If we can engage CQV early, the truth will show up when we can do something about it.”