Operate
Documentation, storage and inventory practice
Reference material for organisations that receive, store and forward research materials. It covers record-keeping and handling only.
This is general educational material about documentation practice. It is not legal or regulatory advice, and the rules that apply to you depend on your jurisdiction, your products and your claims. Take advice from a qualified regulatory professional before relying on any of it.
Your private workspace
Signed-in accounts get a private place to keep certificates and follow compounds. Nothing you upload is shared, listed publicly or shown to suppliers.
Lot traceability
Every unit should trace back to a lot, and every lot to a certificate, a supplier and a receipt date. The practical test: pick any vial at random and reconstruct its full history in under a minute. If you cannot, the records are decorative.
- Record supplier, lot, quantity received, receipt date and storage location at intake, not later
- Keep the certificate filed against the lot, not against the supplier
- Log every movement between storage locations, including temporary ones
- Keep retained samples where your obligations require them
Cold chain and storage
Lyophilised peptides are generally stable frozen and dark; in solution most are not. Freeze-thaw cycles and light exposure are the two failure modes that leave no visible trace.
- Log the temperature of storage units, not just the setpoint
- Record excursions with duration and peak temperature, and decide against a written rule
- Keep shipping conditions on file: courier, transit time, coolant type
- Treat 'arrived warm' as a documented event, not a judgement call
Labelling and packaging
Labelling is where educational material and regulated claims separate. What a label says determines how a product is classified, regardless of what the seller intends.
- Product name, lot, quantity and storage conditions belong on the primary label
- Research-use statements do not neutralise a therapeutic claim made elsewhere in your material
- Human-use language, dosing instructions and health claims change a product's regulatory category
- Keep marketing copy under the same version control as labels
Inventory records
A workable record is one row per lot with the fields below. Spreadsheets are acceptable; undocumented memory is not.
- SKU, lot, quantity on hand, unit cost, supplier
- Certificate reference and test date
- Received date, retest or review date, storage location
- Disposition history: sold, damaged, destroyed, quarantined
Related
The testing guide explains what each analytical method on a certificate demonstrates, and the calculators cover the routine concentration and molar arithmetic.
Crimson Index