[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR211.130]

[Page 151]
 
                        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--Table of Contents
 
                Subpart G_Packaging and Labeling Control
 
Sec.  211.130  Packaging and labeling operations.

    There shall be written procedures designed to assure that correct 
labels, labeling, and packaging materials are used for drug products; 
such written procedures shall be followed. These procedures shall 
incorporate the following features:
    (a) Prevention of mixups and cross-contamination by physical or 
spatial separation from operations on other drug products.
    (b) Identification and handling of filled drug product containers 
that are set aside and held in unlabeled condition for future labeling 
operations to preclude mislabeling of individual containers, lots, or 
portions of lots. Identification need not be applied to each individual 
container but shall be sufficient to determine name, strength, quantity 
of contents, and lot or control number of each container.
    (c) Identification of the drug product with a lot or control number 
that permits determination of the history of the manufacture and control 
of the batch.
    (d) Examination of packaging and labeling materials for suitability 
and correctness before packaging operations, and documentation of such 
examination in the batch production record.
    (e) Inspection of the packaging and labeling facilities immediately 
before use to assure that all drug products have been removed from 
previous operations. Inspection shall also be made to assure that 
packaging and labeling materials not suitable for subsequent operations 
have been removed. Results of inspection shall be documented in the 
batch production records.

[43 FR 45077, Sept. 29, 1978, as amended at 58 FR 41354, Aug. 3, 1993]