[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR211.180]

[Page 132]
 
                        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 J--Records and Reports
 
Sec. 211.180  General requirements.


    (a) Any production, control, or distribution record that is required 
to be maintained in compliance with this part and is specifically 
associated with a batch of a drug product shall be retained for at least 
1 year after the expiration date of the batch or, in the case of certain 
OTC drug products lacking expiration dating because they meet the 
criteria for exemption under Sec. 211.137, 3 years after distribution of 
the batch.
    (b) Records shall be maintained for all components, drug product 
containers, closures, and labeling for at least 1 year after the 
expiration date or, in the case of certain OTC drug products lacking 
expiration dating because they meet the criteria for exemption under 
Sec. 211.137, 3 years after distribution of the last lot of drug product 
incorporating the component or using the container, closure, or 
labeling.
    (c) All records required under this part, or copies of such records, 
shall be readily available for authorized inspection during the 
retention period at the establishment where the activities described in 
such records occurred. These records or copies thereof shall be subject 
to photocopying or other means of reproduction as part of such 
inspection. Records that can be immediately retrieved from another 
location by computer or other electronic means shall be considered as 
meeting the requirements of this paragraph.
    (d) Records required under this part may be retained either as 
original records or as true copies such as photocopies, microfilm, 
microfiche, or other accurate reproductions of the original records. 
Where reduction techniques, such as microfilming, are used, suitable 
reader and photocopying equipment shall be readily available.
    (e) Written records required by this part shall be maintained so 
that data therein can be used for evaluating, at least annually, the 
quality standards of each drug product to determine the need for changes 
in drug product specifications or manufacturing or control procedures. 
Written procedures shall be established and followed for such 
evaluations and shall include provisions for:
    (1) A review of a representative number of batches, whether approved 
or rejected, and, where applicable, records associated with the batch.
    (2) A review of complaints, recalls, returned or salvaged drug 
products, and investigations conducted under Sec. 211.192 for each drug 
product.
    (f) Procedures shall be established to assure that the responsible 
officials of the firm, if they are not personally involved in or 
immediately aware of such actions, are notified in writing of any 
investigations conducted under Secs. 211.198, 211.204, or 211.208 of 
these regulations, any recalls, reports of inspectional observations 
issued by the Food and Drug Administration, or any regulatory actions 
relating to good manufacturing practices brought by the Food and Drug 
Administration.

[43 FR 45077, Sept. 29, 1978, as amended at 60 FR 4091, Jan. 20, 1995]