Manufacturing
A facility that runs capsules well is not automatically a facility that runs stick packs well. Equipment, tooling, experience and failure modes are format specific, and a site taking on a format it rarely produces will learn on your batch.
Ask what proportion of their volume is your dosage form, what batch sizes they run it at routinely rather than at maximum, and what their scrap rate looks like on that line. A manufacturer who has run your format a hundred times will anticipate problems a capable generalist will discover.
The same applies to your ingredient set. Facilities develop expertise in particular material classes. A site experienced with botanicals handles identity verification and pesticide screening as routine. A site that mostly runs synthetic actives may treat it as an exception.
Every manufacturer will say they are GMP compliant. The question is what evidence supports that and who has verified it.
Ask what certifications they hold, who issued them and when they were last audited. Ask to see the scope, because a certificate can cover some activities at a site and not others. Ask about their most recent regulatory inspection and what was found, since a facility with nothing to hide will discuss its findings and corrective actions.
Ask how they qualify their own suppliers, because their supply chain becomes yours. Ask whether the quality unit reports independently of production, since a quality lead reporting to the plant manager has a conflict at exactly the moment it matters.
For Canadian sales the facility needs a site licence. For Australia it needs TGA GMP licensing or clearance. These are not optional and they regularly disqualify an otherwise good manufacturer late in the process, so confirm them before you invest in the relationship.
A manufacturer’s minimum order quantity tells you less than where your volume places you among their customers.
A brand that is a small account at a large facility gets scheduled around larger customers, and a line changeover for your twenty thousand units competes with a run of two hundred thousand. The same brand at a smaller facility is a significant customer with corresponding attention.
Ask about their customer concentration, their typical batch sizes, and what scheduling looks like when a larger customer moves a run. Ask what happens to your timeline in that scenario, because it will happen.
A few questions consistently separate manufacturers who will be straightforward to work with from those who will not.
How do you handle a deviation mid-run, and who makes the call? The answer reveals whether quality has real authority.
What happens if the first production batch fails specification? Who pays, and what is the process? Agreeing this before it happens is considerably easier than after.
Can I attend the first production run? A refusal is a significant signal.
Who writes the master batch record, you or us? Manufacturers who insist on writing it from your formula sheet are often the ones whose documentation is strongest.
What is your change control process when I need a supplier substitution? A vague answer here predicts problems that surface as stability failures eighteen months out.
A per-unit price covers manufacturing. It does not cover tooling, artwork setup, film plates, minimum raw material purchases, stability testing, certification fees, freight, or the inventory sitting on a pallet while you sell through.
Model the landed cost across all of it before comparing quotes, because the cheapest per-unit price frequently belongs to the manufacturer with the highest minimums and the longest lead times, and the total is worse.
Stage the commitment where you can. Structuring the first run so that pilot results inform the raw material purchase, rather than following it, means a formula change after pilot does not write off the entire ingredient buy.
Two things should remain yours regardless of who manufactures.
The formula, documented in a form you could hand to another site. A manufacturer holding your formula as their proprietary blend has made switching very expensive by design.
The supplier relationships for your critical ingredients, or at minimum visibility of them. A branded ingredient licensed to you rather than to your manufacturer travels with you.
Both of these are negotiated at the start of the relationship or not at all.