Lonza Quality Manager's Chemical Buying Checklist: 6 Steps Before You Approve an Order

This checklist is for anyone who buys chemicals, intermediates, or pharma-related raw materials. It's also for teams that are tired of approving a batch and then hoping the next one looks as good as the sample. I'm a quality manager at Lonza. I review product specifications and batch documentation before they reach customers—roughly 200+ unique items a year. Over four years, I've rejected deliveries that looked right on paper but didn't hold up in practice. This is the checklist I wish someone had given me before I started approving orders.

I only believed in checking specs after ignoring them once. We approved a 'close enough' batch on a 50,000-unit order. It failed under storage conditions, the redo cost us $22,000, and the launch slipped. Honestly, this is one of those checklists that exists because someone paid for the lesson.

Use this checklist when you're qualifying a new supplier, renewing a contract, or approving a material you haven't bought in 12 months. It's also useful when a product is going into a new application. That's when hidden assumptions get exposed.

Here are the six checks I run. They're in order, and the last one is the one most buyers forget.

1. Confirm product identity and formula

Start with the basics. If someone asks 'what is the chemical formula for sulfuric acid?' the answer is H₂SO₄. That's not a trick question—it's a screening question. If the technical rep can't answer it without checking, you're talking to the wrong person.

The formula alone still isn't a spec. Sulfuric acid can be concentrated or diluted, reagent grade or technical grade. So ask for the full product identity: formula, grade, CAS number, concentration, and impurity limits. For ethylene glycol, the molecular formula is C₂H₆O₂, but the structural identity—HOCH₂CH₂OH—matters even more. Match everything against your approved list before you go further.

2. Ask about the production process

The process tells you what the certificate of analysis won't. A CoA reports what came out of a batch. It doesn't tell you how it was made. For some products, 'how it was made' is exactly what determines whether it works in your formulation.

Take the ethylene glycol production process. Ethylene glycol is made from ethylene oxide, usually through thermal or catalytic hydration. The catalyst, reaction conditions, and purification steps can influence residual impurities like diethylene glycol. A producer who can explain their ethylene glycol production process is a supplier. A trader who only reads you the label is a middleman. Both can be okay, but you should know which one you're buying from before the batch fails.

Basically, you need to hear enough to confirm they understand which process steps can create the impurities that matter in your application. You don't need a full lecture.

3. Match the quality system to the end use

This is where buyers get into trouble with 'same product, different spec.' GMP materials for pharma and biotech are not the same as industrial-grade chemicals. If you're evaluating Lonza pharma services, the conversation should start with the quality system, not the price per kilogram.

Ask: Which site produced this? Which quality standard is it made under? Does it follow a pharmacopeia method? Is there a certificate of analysis for this specific lot? If the answer is 'we can get that after you order,' flag it.

Also, check the scope. A GMP certificate isn't a blanket license. It covers a specific site, a specific product type, and a specific set of activities. Ask to see that scope and make sure it matches what you're buying.

4. Check packaging, labeling, and documentation

Some buyers ignore everything outside the drum. That's a mistake. For hydrochloric acid for pools, the specification isn't just 'hydrochloric acid.' It's concentration, iron content, container compatibility, and label accuracy. If the iron content is high, it can stain pool surfaces. If the concentration drifts between lots, your dosing calculations drift with it.

The label tells you what's supposed to be inside. The certificate of analysis tells you what's actually inside. Keep the CoA with the lot, and ask for it before shipment, not after. (Should mention: I've rejected orders where the paperwork was perfect but the container markings were wrong. It's not a small detail. It's a traceability failure.)

5. Test consistency, not just purity

A single CoA is a snapshot, not a pattern. Ask for three to five recent lots. Ask if any failed release and why. Most buyers focus on per-unit pricing and completely miss batch-to-batch consistency, and consistency is what separates raw materials from reliable raw materials.

If you're qualifying a new supplier, run a small pilot batch under your own conditions. It costs less than a full shipment and tells you more than any brochure. Even a simple stability check can expose whether the material is the same when you use it, not just when it leaves their factory.

6. Talk to the right contact

The last step is the one people forget. A Lonza contact for a GMP pharma project is not the same Lonza contact for a pool chemicals question. We have separate business units for pharma, biotech, cell culture, chemicals, and pool products. If you email the wrong one, you lose a week.

The question everyone asks is 'do you have this product?' The better question is 'who handles this product for this industry and this specification?' Find that person before you send a request.

When you need a Lonza contact, start from the product line you're buying, not from the company name alone. Include the exact product name, the application, the specification, the volume, and your timeline. A specific request gets to the right person faster than a general inquiry.

Common mistakes that show up in purchase orders

• Buying on a grade name alone. 'Technical grade' means nothing unless it's tied to a standard.
• Only looking at one CoA.
• Ignoring the production process until there's an impurity issue.
• Forgetting to match the quality system to the end use.
• Calling the general contact line instead of the right business unit.
• Not defining acceptance thresholds before the batch arrives.

The best time to ask these questions is before you commit. A supplier who can explain their own process and send the right documents is a supplier who will survive an audit. An informed customer asks better questions and makes faster decisions. That's the kind of customer we like working with at Lonza, and it's probably the kind of customer your current supplier wants too.

If you have a spec you want to pressure-test, find the right Lonza contact and bring this checklist. We'll do the rest.