[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR820.75]

[Page 145-146]
 
                        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 G--Production and Process Controls
 
Sec. 820.75  Process validation.

    (a) Where the results of a process cannot be fully verified by 
subsequent

[[Page 146]]

inspection and test, the process shall be validated with a high degree 
of assurance and approved according to established procedures. The 
validation activities and results, including the date and signature of 
the individual(s) approving the validation and where appropriate the 
major equipment validated, shall be documented.
    (b) Each manufacturer shall establish and maintain procedures for 
monitoring and control of process parameters for validated processes to 
ensure that the specified requirements continue to be met.
    (1) Each manufacturer shall ensure that validated processes are 
performed by qualified individual(s).
    (2) For validated processes, the monitoring and control methods and 
data, the date performed, and, where appropriate, the individual(s) 
performing the process or the major equipment used shall be documented.
    (c) When changes or process deviations occur, the manufacturer shall 
review and evaluate the process and perform revalidation where 
appropriate. These activities shall be documented.