[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR820.80]

[Page 146]
 
                        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 H--Acceptance Activities
 
Sec. 820.80  Receiving, in-process, and finished device acceptance.


    (a) General. Each manufacturer shall establish and maintain 
procedures for acceptance activities. Acceptance activities include 
inspections, tests, or other verification activities.
    (b) Receiving acceptance activities. Each manufacturer shall 
establish and maintain procedures for acceptance of incoming product. 
Incoming product shall be inspected, tested, or otherwise verified as 
conforming to specified requirements. Acceptance or rejection shall be 
documented.
    (c) In-process acceptance activities. Each manufacturer shall 
establish and maintain acceptance procedures, where appropriate, to 
ensure that specified requirements for in-process product are met. Such 
procedures shall ensure that in-process product is controlled until the 
required inspection and tests or other verification activities have been 
completed, or necessary approvals are received, and are documented.
    (d) Final acceptance activities. Each manufacturer shall establish 
and maintain procedures for finished device acceptance to ensure that 
each production run, lot, or batch of finished devices meets acceptance 
criteria. Finished devices shall be held in quarantine or otherwise 
adequately controlled until released. Finished devices shall not be 
released for distribution until:
    (1) The activities required in the DMR are completed;
    (2) the associated data and documentation is reviewed;
    (3) the release is authorized by the signature of a designated 
individual(s); and
    (4) the authorization is dated.
    (e) Acceptance records. Each manufacturer shall document acceptance 
activities required by this part. These records shall include:
    (1) The acceptance activities performed;
    (2) the dates acceptance activities are performed;
    (3) the results;
    (4) the signature of the individual(s) conducting the acceptance 
activities; and
    (5) where appropriate the equipment used. These records shall be 
part of the DHR.