[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR820.40]

[Page 151-152]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 820_QUALITY SYSTEM REGULATION--Table of Contents
 
                       Subpart D_Document Controls
 
Sec. 820.40  Document controls.


    Each manufacturer shall establish and maintain procedures to control 
all documents that are required by this part. The procedures shall 
provide for the following:
    (a) Document approval and distribution. Each manufacturer shall 
designate an individual(s) to review for adequacy and approve prior to 
issuance all documents established to meet the

[[Page 152]]

requirements of this part. The approval, including the date and 
signature of the individual(s) approving the document, shall be 
documented. Documents established to meet the requirements of this part 
shall be available at all locations for which they are designated, used, 
or otherwise necessary, and all obsolete documents shall be promptly 
removed from all points of use or otherwise prevented from unintended 
use.
    (b) Document changes. Changes to documents shall be reviewed and 
approved by an individual(s) in the same function or organization that 
performed the original review and approval, unless specifically 
designated otherwise. Approved changes shall be communicated to the 
appropriate personnel in a timely manner. Each manufacturer shall 
maintain records of changes to documents. Change records shall include a 
description of the change, identification of the affected documents, the 
signature of the approving individual(s), the approval date, and when 
the change becomes effective.