21 CFR 211.184 - Component, Container, Closure and Labeling Records

What it says

Records must be kept for each shipment of each lot of components, drug product containers, closures and labeling, including the identity and quantity, the supplier's name and the supplier's lot number, the date of receipt, the expiration or retest date if any, the results of testing or examination and the conclusions, and a record of the disposition, whether approved or rejected.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• These records link each incoming lot to what was done with it, and so support traceability into finished batches.
• Both the supplier's lot number and the firm's own control number should be captured, so material can be traced either way.
• Records are the proof of the testing and examination required by sections such as 211.84.

What FDA inspectors look for

• Whether records exist for each lot and include the required elements.
• Whether disposition decisions are recorded and match the testing results.
• Whether lot numbers support tracing from supplier to batch.

Related regulations