Section 22-B10710. PRODUCTION AND PROCESS CONTROLS

 

10710.1Each 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 process control procedures that describe any process controls necessary to ensure conformance to specifications. Where process controls are needed they shall include:

 

(a) Documented instructions, standard operating procedures (SOPs), and methods that define and control the manner of production;

 

(b) Monitoring and control of process parameters and component and device characteristics during production;

 

(c) Compliance with specified reference standards or codes;

 

(d) The approval of processes and process equipment; and

 

(e)Criteria for workmanship which shall be expressed in documented standards or by means of identified and approved representative samples.
 

10710.2Each 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 § 10713, before implementation and these activities shall be documented. Changes shall be approved in accordance with § 10706.

 

10710.3Where 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.

 

10710.4Each 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.
 

10710.5Each 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.

 

10710.6Buildings shall be of suitable design and contain sufficient space to perform necessary operations, prevent mix-ups, and assure orderly handling.

 

10710.7Each 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.

 

10710.8Each 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.

 

10710.9Each 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.

 

10710.10Each 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.

 

10710.11Where 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.
 

10710.12When computers or automated data processing systems are used as part of production or the quality system, the manufacturer shall validate computer software 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.

 

 

authority

Section 19(a)(3) of the District of Columbia Pharmacist and Pharmacy Regulation Act of 1980, effective September 16, 1980 (D.C. Law 3-98; D.C. Official Code § 47-2885.18(a)(3) (2005 Repl.)); Mayor’s Order 98-48, dated April 15, 1998; Section 4902 of the Fiscal Year 2002 Budget Support Act of 2001, effective October 3, 2001 (D.C. Law 14-28; D.C. Official Code § 7-731 (2008 Repl.)); Section 15 of the District of Columbia Medical Device Manufacture and Distribution Licensure Act of 1990, effective June 13, 1990 (D.C. Law 8-137; D.C. Official Code § 48-714(a) (2005 Repl.)); and Mayor’s Order 98-88, dated May 29, 1998.

source

Final Rulemaking published at 60 DCR 10252 (July 12, 2013).