[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR820.70]

[Page 152-154]
 
                        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. 820.70  Production and process controls.


    (a) General. Each manufacturer shall develop, conduct, control, and 
monitor production processes to ensure that a device conforms to its 
specifications. Where deviations from device specifications could occur 
as a result of the manufacturing process, the manufacturer shall 
establish and maintain

[[Page 153]]

process control procedures that describe any process controls necessary 
to ensure conformance to specifications. Where process controls are 
needed they shall include:
    (1) Documented instructions, standard operating procedures (SOP's), 
and methods that define and control the manner of production;
    (2) Monitoring and control of process parameters and component and 
device characteristics during production;
    (3) Compliance with specified reference standards or codes;
    (4) The approval of processes and process equipment; and
    (5) Criteria for workmanship which shall be expressed in documented 
standards or by means of identified and approved representative samples.
    (b) Production and process changes. Each manufacturer shall 
establish and maintain procedures for changes to a specification, 
method, process, or procedure. Such changes shall be verified or where 
appropriate validated according to Sec. 820.75, before implementation 
and these activities shall be documented. Changes shall be approved in 
accordance with Sec. 820.40.
    (c) Environmental control. Where environmental conditions could 
reasonably be expected to have an adverse effect on product quality, the 
manufacturer shall establish and maintain procedures to adequately 
control these environmental conditions. Environmental control system(s) 
shall be periodically inspected to verify that the system, including 
necessary equipment, is adequate and functioning properly. These 
activities shall be documented and reviewed.
    (d) Personnel. Each manufacturer shall establish and maintain 
requirements for the health, cleanliness, personal practices, and 
clothing of personnel if contact between such personnel and product or 
environment could reasonably be expected to have an adverse effect on 
product quality. The manufacturer shall ensure that maintenance and 
other personnel who are required to work temporarily under special 
environmental conditions are appropriately trained or supervised by a 
trained individual.
    (e) Contamination control. Each manufacturer shall establish and 
maintain procedures to prevent contamination of equipment or product by 
substances that could reasonably be expected to have an adverse effect 
on product quality.
    (f) Buildings. Buildings shall be of suitable design and contain 
sufficient space to perform necessary operations, prevent mixups, and 
assure orderly handling.
    (g) Equipment. Each manufacturer shall ensure that all equipment 
used in the manufacturing process meets specified requirements and is 
appropriately designed, constructed, placed, and installed to facilitate 
maintenance, adjustment, cleaning, and use.
    (1) Maintenance schedule. Each manufacturer shall establish and 
maintain schedules for the adjustment, cleaning, and other maintenance 
of equipment to ensure that manufacturing specifications are met. 
Maintenance activities, including the date and individual(s) performing 
the maintenance activities, shall be documented.
    (2) Inspection. Each manufacturer shall conduct periodic inspections 
in accordance with established procedures to ensure adherence to 
applicable equipment maintenance schedules. The inspections, including 
the date and individual(s) conducting the inspections, shall be 
documented.
    (3) Adjustment. Each manufacturer shall ensure that any inherent 
limitations or allowable tolerances are visibly posted on or near 
equipment requiring periodic adjustments or are readily available to 
personnel performing these adjustments.
    (h) Manufacturing material. Where a manufacturing material could 
reasonably be expected to have an adverse effect on product quality, the 
manufacturer shall establish and maintain procedures for the use and 
removal of such manufacturing material to ensure that it is removed or 
limited to an amount that does not adversely affect the device's 
quality. The removal or reduction of such manufacturing material shall 
be documented.
    (i) Automated processes. When computers or automated data processing 
systems are used as part of production or the quality system, the 
manufacturer shall validate computer software

[[Page 154]]

for its intended use according to an established protocol. All software 
changes shall be validated before approval and issuance. These 
validation activities and results shall be documented.