§ 211.184 Component, drug product container, closure, and labeling records.
These records shall include the following:
(a) The identity and quantity of each shipment of each lot of components, drug product containers, closures, and labeling; the name of the supplier; the supplier's lot number(s) if known; the receiving code as specified in § 211.80; and the date of receipt. The name and location of the prime manufacturer, if different from the supplier, shall be listed if known.
(b) The results of any test or examination performed (including those performed as required by § 211.82(a), § 211.84(d), or § 211.122(a)) and the conclusions derived therefrom.
(c) An individual inventory record of each component, drug product container, and closure and, for each component, a reconciliation of the use of each lot of such component. The inventory record shall contain sufficient information to allow determination of any batch or lot of drug product associated with the use of each component, drug product container, and closure.
(d) Documentation of the examination and review of labels and labeling for conformity with established specifications in accord with §§ 211.122(c) and 211.130(c).
(e) The disposition of rejected components, drug product containers, closure, and labeling.
How BatchGlow handles this
For each received lot, BatchGlow records the supplier, the manufacturer and the supplier's lot from the purchase receipt. Staging and weighing use a lot only when its supplier and manufacturer are on the formula's supplier list and qualified for it.
What it asks for, in plain words
- 21 CFR 211.184
- Records of components, containers, closures and labeling give for each shipment of each lot the identity, quantity, supplier, supplier's lot, receiving code and date, and the name and location of the prime manufacturer if it is not the supplier and is known; the test results and conclusions; an inventory record of each component, container and closure that identifies the batches made with it, and for each component a reconciliation of each lot's use; label examinations; and what was done with rejected material.
These summaries are BatchGlow's reading of the text on this page, checked against it on 5 Oct 2026. The text governs.