[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: 21CFR211.110]

[Page 123-124]
 
                        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 F--Production and Process Controls
 
Sec. 211.110  Sampling and testing of in-process materials and drug products.

    (a) To assure batch uniformity and integrity of drug products, 
written procedures shall be established and followed that describe the 
in-process controls, and tests, or examinations to be conducted on 
appropriate samples of in-process materials of each batch. Such control 
procedures shall be established to monitor the output and to validate 
the performance of those manufacturing processes that may be responsible 
for causing variability in the characteristics of in-process material

[[Page 124]]

and the drug product. Such control procedures shall include, but are not 
limited to, the following, where appropriate:
    (1) Tablet or capsule weight variation;
    (2) Disintegration time;
    (3) Adequacy of mixing to assure uniformity and homogeneity;
    (4) Dissolution time and rate;
    (5) Clarity, completeness, or pH of solutions.
    (b) Valid in-process specifications for such characteristics shall 
be consistent with drug product final specifications and shall be 
derived from previous acceptable process average and process variability 
estimates where possible and determined by the application of suitable 
statistical procedures where appropriate. Examination and testing of 
samples shall assure that the drug product and in-process material 
conform to specifications.
    (c) In-process materials shall be tested for identity, strength, 
quality, and purity as appropriate, and approved or rejected by the 
quality control unit, during the production process, e.g., at 
commencement or completion of significant phases or after storage for 
long periods.
    (d) Rejected in-process materials shall be identified and controlled 
under a quarantine system designed to prevent their use in manufacturing 
or processing operations for which they are unsuitable.