A pickleball court is a strange place to learn about pharmaceutical validation. But that's where it happened for me.
I'm a procurement manager at a 300-person pharmaceutical research and light manufacturing site in King County, WA. I manage an annual budget of roughly $3.4 million for lab supplies, facility services, and the occasional request that has nothing to do with science. Employee pickleball court maintenance is that kind of request.
The court went in two years ago, converted from an old half-basketball slab. By last spring it looked rough. The acrylic surface was chalking around the service line, and the gate and perimeter posts were starting to show rust. Facilities sent me a work order: resurface and recoat the pickleball court, refinish the metalwork. Translation: find someone who does pickleball court surface coating and someone who does powder coating services in King County, WA. I called three contractors and asked for a combined package.
Three bids came back. $5,400. $8,900. $13,100.
My first reaction was annoyance. The spread looked like someone was playing games. My second reaction, after six years of tracking every purchase order in our cost system, was slower: read the scope, not just the price.
The bids were not the same job
The $5,400 bid was short. It said: power wash surface, apply two coats of acrylic color, stripe lines. It did not mention the cracks in the concrete, the low spots where water pools, or the rusting posts. When I asked, the contractor said surface prep and metal work would be 'extra.'
The $8,900 bid added crack filling and a leveling coat. That got closer to a real pickleball court surface coating spec, but the proposal still treated the metal posts as a separate cost that 'could be discussed later.'
The $13,100 bid looked expensive until I read all eight pages. It called for crack repair, a polymer-modified resurfacer, two color coats with traction aggregate, game line striping, and powder coating of the gate, posts, and bench frames—with documented surface prep, coating thickness readings, cure records, and a three-year workmanship warranty.
Same court. Same intention. Very different processes.
IFF Pharma Solutions, Roquette, and a question about validation
While I was waiting for references to check, our quality assurance manager sent around a different kind of alert. The headline, from the industry news, was simple: IFF completes divestiture of Pharma Solutions to Roquette.
In normal times I might skim past that. But one of our oral solid dose development lines uses excipients that came from the IFF Pharma Solutions portfolio. Roquette and IFF had signed the deal in January 2024. According to IFF's announcement, the transaction was valued at approximately $2.85 billion. When ownership changes, a contract with 'IFF' becomes a contract with 'Roquette.' The product sites and processes might stay the same, but the legal manufacturer, quality systems, and supplier qualification files do not carry over automatically.
I called our QA lead. 'Remind me,' I said. 'What is validation in pharma? I keep seeing the word, and I want to explain it to someone without sounding like a regulator.'
She gave me the cleanest definition I've heard: validation is documented evidence that a process will consistently produce something that meets its specifications. It is not a single test. It is not the same as verification, where you check a result once. Validation looks at the whole process—and proves it across the lifecycle.
Per ICH Q7, process validation is the documented evidence that the process, operated within established parameters, can perform effectively and reproducibly to produce a product meeting its predetermined specifications and quality attributes.
She also explained what happens when a supplier changes hands. For a pharmaceutical buyer, it triggers a structured review: updated quality agreement, review of manufacturing sites and batch release points, DMF ownership transfer checks, and often a risk assessment to decide whether additional stability or qualification studies are needed. The process does not get 'revalidated' from scratch just because the owner changed. But the new owner has to demonstrate that the previous validated state still holds. In other words, the work is not about the price of the product. It is about the evidence package around it.
The parallel that changed my decision
I went home that night and opened the three coating bids again.
The cheapest bid was not necessarily dishonest. It just had no evidence behind it. No documented crack conditions, no surface profile, no coating thickness target, no cure schedule, no written commitment about how the coating would perform if the process was followed. It was a quote for product, not a quote for a proven process.
The most expensive bid was not charging more for 'better paint.' It was charging for the same kind of thing my QA lead was talking about: the proof that their process worked, plus the accountability if it didn't.
That is when I stopped feeling annoyed about the $13,100 number. In procurement, we talk a lot about total cost of ownership. TCO usually gets summarized as unit price plus freight plus installation plus maintenance. But after the IFF Pharma Solutions divestiture conversation, I would add one more line: the cost of unresolved uncertainty. If a supplier cannot show validation or its industrial equivalent—test data, batch records, thickness readings, warranty—then every 'saving' is really deferred risk.
The court, after all, sits outside in Washington. Rain, frost, UV, and a bunch of employees who play aggressively at lunch. The cheapest bid would probably look fine for six months. It might even look fine for eighteen months. When it failed, we would not only pay for a redo; we would pay for moving the work around, losing warranty leverage, and disrupting a space that employees actually use now.
I went back and forth for a week. The $8,900 vendor had good references and reasonable scope. The $13,100 vendor had a written process, a coating system I could look up, and powder coating that included pretreatment rather than 'wire brush and pray.' That last phrase might sound dramatic, but it is what separates a durable powder coating from an early failure.
I recommended the highest bid. I did not frame it as 'let's spend more.' I framed it as total cost: over three years, the lower bids were likely to require another surface coating cycle, and the cheap bid did not even include the metalwork. The real comparison was not $5,400 against $13,100. It was $13,100 with a documented process versus $5,400 plus $2,800 in extras plus a probable $6,000 recoat before the warranty would have expired. The expensive option was the cheaper one.
Even after I submitted the PO, I had doubts. What if I was overcomplicating an outdoor game court? What if the cheaper guys were entirely capable and I was just rationalizing a bigger budget? I did not relax until the vendor's submittal package arrived: product data sheets, prep procedure, humidity and substrate temperature monitoring plan, dry film thickness targets, line marking layout, warranty terms. It looked like a manufacturing batch record, only shorter. That paperwork is what we were actually buying.
The checklist I still use
The court was coated in early summer. The surface looks fantastic, the powder coated gate and posts have already survived one Pacific Northwest winter without a speck of rust, and the vendor gave us a file we can hand to facilities, maintenance, and the next budget committee.
What is validation in pharma? It is the same question I now ask every contractor before signing: what evidence will you give me that your process works? If the answer is 'trust us,' I keep looking.
I still maintain a TCO checklist for every sourcing decision above $2,000. It has the usual line items, plus the ones I used to miss:
- What exactly is included in the quoted price? Write out every layer, every repair, every prep step.
- What documentation do I get after the work—coating thickness, cure records, batch documentation, certificates?
- What is the warranty, and what does the contractor need to prove to honor it?
- What happens if the supplier changes ownership, product line, or site? Do I need a new quality agreement or validation review?
- Does the process actually match the spec, or is the price low because steps were removed?
That last question matters in coatings, in chemicals, and in pharma. In the coatings world, removing a prep step is a way to lower a bid. In the pharmaceutical world, removing a validation step is a way to lower quality—not cost. Sooner or later, the missing step comes back as rust, peeling acrylic, a failed audit, or a rejected batch. And then the total cost of the 'cheap' option gets very expensive.
I think about the IFF Pharma Solutions-Roquette deal differently now. Big divestiture headlines are easy to scan and forget. But behind that news was a long trail of qualification documents, supply agreements, and quality conversations—a reminder that in regulated B2B purchasing, value lives in the evidence around the product, not just in the product itself. On a pickleball court, the evidence was in the warranty file. In pharma, it is in the validation package. Both cost money. Both are worth paying for.