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FDA Title 21 Information for GLP and GMP facilities.
Part 820 - GLP For Nonclinical Laboratory Studies

Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR820.72]
[Page 159-160]
 
                        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 G_Production and Process Controls
 
Sec. 820.72  Inspection, measuring, and test equipment.
 
    (a) Control of inspection, measuring, and test equipment. Each 
manufacturer shall ensure that all inspection, measuring, and test 
equipment, including mechanical, automated, or electronic inspection and 
test equipment, is suitable for its intended purposes and is capable of 
producing valid results. Each manufacturer shall establish and maintain 
procedures to ensure that equipment is routinely calibrated, inspected, 
checked, and maintained. The procedures shall include provisions for 
handling, preservation, and storage of equipment, so that its accuracy 
and fitness for use are maintained. These activities shall be 
documented.
    (b) Calibration. Calibration procedures shall include specific 
directions and limits for accuracy and precision. When accuracy and 
precision limits are not met, there shall be provisions for remedial 
action to reestablish the limits and to evaluate whether there was any 
adverse effect on the device's quality. These activities shall be 
documented.
    (1) Calibration standards. Calibration standards used for 
inspection, measuring, and test equipment shall be traceable to national 
or international standards. If national or international standards are 
not practical or available, the manufacturer shall use an independent 
reproducible standard. If
 
[[Page 160]]
 
no applicable standard exists, the manufacturer shall establish and 
maintain an in-house standard.
    (2) Calibration records. The equipment identification, calibration 
dates, the individual performing each calibration, and the next 
calibration date shall be documented. These records shall be displayed 
on or near each piece of equipment or shall be readily available to the 
personnel using such equipment and to the individuals responsible for 
calibrating the equipment.
 
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