[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR211.80]

[Page 140]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 211_CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS--
 
Subpart E_Control of Components and Drug Product Containers and Closures
 
Sec.  211.80  General requirements.


    (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).