[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR211.165]

[Page 128-129]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 211--CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS--Table of Contents
 
                     Subpart I--Laboratory Controls
 
Sec. 211.165  Testing and release for distribution.

    (a) For each batch of drug product, there shall be appropriate 
laboratory determination of satisfactory conformance to final 
specifications for the drug product, including the identity and strength 
of each active ingredient, prior to release. Where sterility and/or 
pyrogen testing are conducted on specific batches of shortlived 
radiopharmaceuticals, such batches may be released prior to completion 
of sterility and/or pyrogen testing, provided such testing is completed 
as soon as possible.
    (b) There shall be appropriate laboratory testing, as necessary, of 
each

[[Page 129]]

batch of drug product required to be free of objectionable 
microorganisms.
    (c) Any sampling and testing plans shall be described in written 
procedures that shall include the method of sampling and the number of 
units per batch to be tested; such written procedure shall be followed.
    (d) Acceptance criteria for the sampling and testing conducted by 
the quality control unit shall be adequate to assure that batches of 
drug products meet each appropriate specification and appropriate 
statistical quality control criteria as a condition for their approval 
and release. The statistical quality control criteria shall include 
appropriate acceptance levels and/or appropriate rejection levels.
    (e) The accuracy, sensitivity, specificity, and reproducibility of 
test methods employed by the firm shall be established and documented. 
Such validation and documentation may be accomplished in accordance with 
Sec. 211.194(a)(2).
    (f) Drug products failing to meet established standards or 
specifications and any other relevant quality control criteria shall be 
rejected. Reprocessing may be performed. Prior to acceptance and use, 
reprocessed material must meet appropriate standards, specifications, 
and any other relevant critieria.