21 CFR 211.80 General Requirements

Overview:

21 CFR 211.80 requires written procedures for the receipt, storage, handling, testing, and approval or rejection of components and drug product containers. 

These procedures must ensure contamination prevention, proper storage conditions, and clear identification of each lot with distinctive codes for tracking. Each lot must be marked with its status (quarantined, approved, or rejected).

(a) 

There shall be written procedures describing in sufficient detail the receipt, identification, storage, handling, sampling, testing, and approval or rejection of components and drug product containers and closures; such written procedures shall be followed.

(b) 

Components and drug product containers and closures shall at all times be handled and stored in a manner to prevent contamination.

(c) 

Bagged or boxed components of drug product containers, or closures shall be stored off the floor and suitably spaced to permit cleaning and inspection.

(d) 

Each container or grouping of containers for components or drug product containers, or closures shall be identified with a distinctive code for each lot in each shipment received. This code shall be used in recording the disposition of each lot. Each lot shall be appropriately identified as to its status (i.e., quarantined, approved, or rejected).