Notices about specific lots are rare for a product as simple as bacteriostatic water, but they happen, and the response is much easier when it has been thought through in advance. A notice may come from the manufacturer, from the distributor or supplier that sold the lot, or from a public listing of product notices. Whatever the source, the procedure is the same.
1. Read the notice and identify the lots
A notice names one or more lot numbers, states the reason (a test result, a labeling error, a packaging defect, a stability concern) and says what to do with affected stock. Note whether the notice covers every vial size or only some, and whether it applies to specific expiration dates. See lot numbers and traceability for where the lot number appears on the vial and carton.
2. Check stock
Check unopened cartons, opened vials on benches and any vials retained as samples. The receiving log lists every lot that entered the laboratory and when; it is the quickest way to know whether an affected lot is present at all.
3. Quarantine
Move affected vials to a marked quarantine location, label them “DO NOT USE: NOTICE” with the date, and record the quantity. Do not discard them yet: the supplier may ask for them back or for photographs, and the count is needed for the response.
4. Trace what was prepared with the lot
Search preparation records and the opened-vial log for the lot number. Every solution made with an affected vial is listed, together with what it was used for. This step is only possible if the diluent lot was recorded at the time each solution was made, which is the reason that record is kept. See labeling and record-keeping for prepared solutions.
5. Assess the impact
The reason for the notice decides the impact. A labeling error on the carton may affect nothing already done. A sterility or endotoxin result may mean that solutions prepared from the lot are discarded and work repeated. A container-closure concern may only apply to unopened stock. Write the assessment down, including the decision to repeat or not repeat work and who made it.
6. Respond and document
Reply to the supplier as the notice instructs (return, destroy with confirmation, or hold), keep a copy of the notice and the reply in the reagent file for the lot, and record the disposal of quarantined vials in the waste log. If the laboratory operates under a quality system, the event is also logged as a deviation or nonconformance and closed with the records above. See documentation in GLP and ISO/IEC 17025 laboratories.
Being ready in advance
- Keep the certificate of analysis for every lot, and keep receiving records by lot.
- Record the diluent lot in every preparation record.
- Keep the supplier’s contact details with the reagent file, and make sure the supplier has a current e-mail address for notices.
- Buy in quantities that turn over: a laboratory holding a year of stock has more exposure to any single lot than one holding a month. See running a stockroom supply.
Related
How to read a COA · Real vs. substandard bacteriostatic water · SOP template
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