Glossary
Distribution Records
The record of which lot of which product went to whom, when, and in what quantity — the basis for finding where product is if a recall becomes necessary.
Details
21 CFR 211.196 requires distribution records to contain the name, strength, and dosage form of the product, the name and address of the consignee, the date and quantity shipped, and the lot or control number; 211.150(b) requires a system by which the distribution of each lot can be readily determined to facilitate recall if necessary, and (a) requires a procedure whereby the oldest approved stock is distributed first. If a return is the record of product that came back and a recall is the decision to call product in, the distribution record is the only basis for answering which lot is where and in what quantity when a recall has to be executed — without it the scope of a recall cannot be set. Inspections cite distribution records missing the lot number or the consignee's address, records kept by product rather than by lot, and, in a Canadian finding, a computerised system managing distribution records that had not been validated.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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For example, your QU failed to ensure the following: • An adequate system for retention of production, control, or distribution records…
FDA · FDA Warning Letter · 2024-08-27 -
Your firm failed to maintain written production, control, or distribution records specifically associated with a batch of a drug product for at least one year after the expiration date of the batch (CFR 211.180(a)).
FDA · FDA Warning Letter · 2022-11-01 -
Distribution records do not contain the lot or control number of drug product.
FDA · FDA 483 · 2022-04-15
