A lab sample you like shows that one batch, made on development equipment, turned out the way you wanted. A production line uses different vessels, batch sizes and filling equipment, so the result can change. Scale-up means handing the formula and process to the manufacturing team, finding out which of those differences matter, and running a pilot designed to answer that question.
This guide is for brand teams coordinating that handover. It covers what to send, what to compare, what to agree before the pilot and how to review the results. Process settings stay with the manufacturer’s technical team. The cosmetic product development roadmap shows where scale-up sits alongside safety, documentation and launch.
Decide what the pilot is for
A pilot is a planned trial run on the proposed production setup. Before booking one, write down the question it should answer. Common ones are:
- Does the documented process work on the receiving site’s equipment?
- Can the filling and packing line handle this product in this pack?
- Do we know enough to commit to a first commercial batch?
Record alongside it what the pilot will leave out and which commitment waits on the result. That way, when someone later says the pilot passed, everyone knows what was tested. Whether formal process validation is also needed is for the manufacturer’s quality team to decide.
In the EU, Article 8 of Regulation (EC) No 1223/2009 requires cosmetics to be manufactured under good manufacturing practice, presumed where the relevant harmonised standards are followed. The regulation sets no pilot size.
Step 1: Assemble the transfer package
The receiving team needs the documents behind the sample, in their current versions:
- Formula and materials: formula reference and version, quantitative composition (as far as your agreement allows disclosure), raw-material identities and specifications, and any known substitutions.
- Manufacturing instructions: the written process, including handling, transfer, holding and filling steps.
- Product specifications: what gets checked, by which method, against which limits, and who owns each.
- Pack references: container, closure and dispenser specifications for the intended configuration.
- History: development reports, changes, deviations and open questions.
- Gaps: anything missing, and who is supposed to supply it.
The Production section of the FDA’s GMP guidelines/inspection checklist for cosmetics asks whether written formulations, processing, transfer and filling instructions and in-process control methods are maintained. MoCRA requires FDA to set GMP regulations for cosmetic facilities. Meanwhile the checklist is a fair baseline for what a manufacturer should hold.
Check that the receiving team is allowed to see each document under your agreements. If you are unsure who controls the formula, read who owns your cosmetic formula first. List any missing item by name, with an owner, before the handover counts as complete.
Step 2: Compare the development and production setups
Ask the technical teams to name each difference that could change the product and say how the pilot will test it. The FDA checklist’s Equipment section asks whether equipment for processing, holding, transfer and filling is of appropriate design and material. It gives no scale-up ratio and no test for whether two machines are equivalent, so that judgment has to come from the people who know the equipment.
Resist the urge to scale lab settings in proportion to batch size. Ask the team to propose the production process and explain their reasoning.
Step 3: Agree the plan and acceptance criteria before the run
Settle how results will be judged before anyone runs the batch. The FDA checklist’s Production section expects samples to be taken during or after processing, transfer or filling, and its Laboratory Controls section expects testing against specifications. The manufacturer and its quality reviewers should propose that plan. Your role is to check that it answers your question.
Copy this checklist into the project record and get it completed before the pilot is authorized:
PROJECT / PLAN VERSION / DATE:
QUESTION THE PILOT ANSWERS:
DECISION THAT WAITS ON IT:
FORMULA / MATERIAL / PACK / INSTRUCTION REFERENCES:
READINESS
- Transfer documents received / still missing:
- Receiving equipment and the differences that matter:
- Who may receive confidential information:
- Technical, quality and brand decision owners:
SCOPE
- Steps covered / excluded / only partly represented:
- How the pilot relates to commercial manufacture:
- Checks, methods and acceptance criteria:
- Sampling plan and rationale:
- Records and report contents required:
- How deviations and unexpected findings are reported:
AFTER THE RUN
- Who reviews the results:
- Questions the pilot will not answer:
- What may proceed next, and what stays on hold:
- Changes that would trigger a re-review:
Close any missing input before the run. If a step is excluded, state it in both the report and the decision record.
Step 4: Keep the record of what actually happened
Reviewers need the executed batch record, which can differ from the plan. The FDA checklist’s Records section lists what to keep for each batch: kinds, lots and quantities of material; processing, handling, transfer, holding and filling; sampling, adjusting and reworking; batch code marks; and finished-product test results.
Ask the receiving team to reconcile:
- Formula, material, equipment and pack identities against the agreed references.
- Work done against the planned steps and checks.
- Any deviation, substitution or adjustment, with its explanation.
- Results against the agreed criteria.
- Open questions, each with an owner.
A side-by-side sensory comparison with the lab sample can be one of the agreed checks, alongside the specified tests.
Step 5: Review the results before the next commitment
Three separate questions need answers. Did the run meet its agreed criteria? Do the results apply to the product and process you intend to sell? What may happen next? The lab, the manufacturer and the brand may each answer a different one, so record who answered which.
A successful pilot can justify a first commercial batch, another trial or further investigation. Process validation, the safety assessment and batch release each have their own owners and evidence.
When the review finds a gap, write it down with an owner and a hold. For example: “Production mixer differs from development equipment; effect on the process not yet assessed. Manufacturing lead to describe the setup and propose the pilot scope. Pilot authorization on hold until the quality reviewer accepts the plan.”
Step 6: Re-check earlier results after a change
When something changes, ask which earlier results still apply. Some evidence may carry over and some may need repeating. Log changes to formula, material source, site, equipment, instructions, holding or filling, and pack, and ask the technical team which earlier evidence each one affects. Two versions sold under the same product name can still differ in ways that matter.
Formula-pack and microbiology questions need their own evidence. See the stability and packaging compatibility guide and the preservative efficacy versus microbiological quality comparison.
Update the transfer package and decision record together, so anyone can identify the current production version and the evidence behind it.
Where to start
Send the receiving team the transfer package and the pilot question from the top of your checklist, and ask them to return the setup comparison table filled in. Their answers will show whether you are ready to schedule a pilot or still have documents to chase.
