Scaling Up Without Re-checking the Numbers
A lab-scale trial of a new fragrance in a cream base was assessed and approved. The pilot batch used a concentrate at 1.2% in the cream. For the production batch, the factory scales up and, to compensate for what it believes is weaker odour intensity in the larger vessel, increases the concentrate to 1.8% without telling the safety assessor. The factory also substitutes one minor ingredient in the base cream with a cheaper equivalent from a different supplier. The production batch is packaged and shipped before the safety file is updated. A retailer later asks for the safety documentation.
1. What compliance problems arise from the two changes made at scale-up?
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Two distinct problems:
- Increased concentrate loading from 1.2% to 1.8% raises every restricted material in the concentrate by 50%. A material that was compliant at 1.2% may now exceed its finished-product limit at 1.8%. The approved assessment no longer describes the product.
- Base ingredient substitution introduces an unassessed material. The new supplier's equivalent may differ in composition, purity, or restricted content, and it was never evaluated. The safety file therefore does not cover the product as shipped.
Both changes were made without notifying the assessor, so the shipped product is outside the scope of its safety assessment - a documentation and compliance failure independent of whether the product happens to be safe.
2. How should the assessor respond when the retailer requests documentation?
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The assessor cannot issue documentation that misrepresents the shipped product. The honest response is to disclose that the shipped batch differs from the assessed formulation and to initiate a retrospective assessment of the actual formulation: recalculate restricted materials at 1.8% loading, obtain the composition of the substituted base ingredient, and evaluate it. If the shipped product is found compliant, the file can be updated to cover it. If not, the assessor must escalate - potentially a market withdrawal or reformulation - and inform the retailer of the status rather than supplying a document that describes a different product.
3. What controls should be put in place to prevent recurrence?
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Implement a change-control procedure requiring safety-assessor sign-off before any change to concentrate loading, formulation, or supplier of a fragrance or base ingredient. Tie the safety file to a controlled formulation version, so that production cannot run a different version without a new assessment. Require batch records to state the assessed formulation version and loading. Add a gate before packaging and shipping that checks the batch against the current approved file. Train factory staff that odour adjustment by changing loading is a formulation change, not a production tweak, and that supplier substitution requires quality and safety review.