[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: 21CFR211.160]

[Page 129]
 
                        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 I--Laboratory Controls
 
Sec. 211.160  General requirements.


    (a) The establishment of any specifications, standards, sampling 
plans, test procedures, or other laboratory control mechanisms required 
by this subpart, including any change in such specifications, standards, 
sampling plans, test procedures, or other laboratory control mechanisms, 
shall be drafted by the appropriate organizational unit and reviewed and 
approved by the quality control unit. The requirements in this subpart 
shall be followed and shall be documented at the time of performance. 
Any deviation from the written specifications, standards, sampling 
plans, test procedures, or other laboratory control mechanisms shall be 
recorded and justified.
    (b) Laboratory controls shall include the establishment of 
scientifically sound and appropriate specifications, standards, sampling 
plans, and test procedures designed to assure that components, drug 
product containers, closures, in-process materials, labeling, and drug 
products conform to appropriate standards of identity, strength, 
quality, and purity. Laboratory controls shall include:
    (1) Determination of conformance to appropriate written 
specifications for the acceptance of each lot within each shipment of 
components, drug product containers, closures, and labeling used in the 
manufacture, processing, packing, or holding of drug products. The 
specifications shall include a description of the sampling and testing 
procedures used. Samples shall be representative and adequately 
identified. Such procedures shall also require appropriate retesting of 
any component, drug product container, or closure that is subject to 
deterioration.
    (2) Determination of conformance to written specifications and a 
description of sampling and testing procedures for in-process materials. 
Such samples shall be representative and properly identified.
    (3) Determination of conformance to written descriptions of sampling 
procedures and appropriate specifications for drug products. Such 
samples shall be representative and properly identified.
    (4) The calibration of instruments, apparatus, gauges, and recording 
devices at suitable intervals in accordance with an established written 
program containing specific directions, schedules, limits for accuracy 
and precision, and provisions for remedial action in the event accuracy 
and/or precision limits are not met. Instruments, apparatus, gauges, and 
recording devices not meeting established specifications shall not be 
used.