What you have to write down
Updated
More records here than anywhere else in this estate, because more regimes reach the product.
Four record sets
Batch records, one per batch.
Raw material records: supplier, lot, certificate of analysis, safety data sheet.
Stability and test records: container compatibility, freeze-thaw, challenge test.
The compliance file, which is the set that distinguishes this category.
The batch record
Batch code and date. Formula with the actual weights. Lot number of every raw material. Order of addition and any deviation. pH before and after adjustment, and the adjuster used. Viscosity. Appearance and odor. Batch weight. Units filled, units rejected, where they went.
The batch code goes on the bottle, or the record cannot be connected to a product in somebody's hand.
The compliance file
The current label artwork for each product, dated, with a note of what changed and when.
The hazard classification and the basis for the cautionary labeling.
The calculation showing where each listed substance sits against the child-resistant packaging thresholds, recalculated on every reformulation. This is the one nobody keeps and the one that answers the hardest question.
Safety data sheets, yours and your suppliers'.
The ingredient disclosure as published, with dates.
And a record of the claim review: what the label, the listings and the marketing say, checked against the claim rules, with a date.
The retrieval test
Hand yourself a bottle with a code on it. How long to produce the formula as made, the lots of every material, the pH and viscosity on release, the label version, the hazard basis and the list of who received the batch?
Under an hour is a working system. Run it on a quiet afternoon rather than on the day it matters.