Quality System Regulations

Quality System Regulation, Production and Process Controls, (1998), CER, Title 21, Part 820, Volume 8, Section 820.75. 

Good manufacturing practice See Quality system regulation. 

Quality system regulation The past good manufacturing practice (GMP) and process validation (PV) was renamed to quality system regulation (QSR). It is important for the medical device industry (that uses an extensive amount of plastics) and also in other product industries where they want to follow strict processing procedures. It sets up an important procedure for many plastic fabricators to consider that targets to ensure meeting zero defects. 

The Quality System Regulation is introduced for medical devices, requiring developers of high-risk devices to apply design controls. 

Figure 9.10 Comparison of headings of the design control elements of IS013485 and the Quality System Regulation (QSR).

Risk Class Device Evaluation Quality System Regulations Marketing Authorisation... 

Sec. 820.130 Device packaging - Packaging must provide adequate protection of the device Figure 11.15 Headings of the Quality System Regulations (QSR) from 21 CFR Part 820. 

GER Part 820 Quality System Regulation Medical Devices Current Good... 

Figure12.4 Quality System Regulation subsystems from the FDA guide to inspection of quality systems.

One of the alternative approaches under the 510(k) paradigm is Special 510(k) Device Modifications. This approach utilizes certain aspects of the Quality System Regulations (Quality System Requirements for Good Manufacturing Practices). The other alternative is the Abbreviated 510(k). This approach utilizes special controls in which standards or voluntary guidelines can facilitate 510(k) review and expedite evaluation. 

Quality System Regulation, Code of Federal Regulations, 21 CFR 820 (1996)... 

U.S. Code of Federal Regulations (CFR), Title 21, Part 820, Quality system regulation for medical devices, available http //www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/ CFRSearch.cfm CFRPart=820, accessed Dec. 5, 2006. 

Software validation is not separately defined in the quality system regulation. The FDA considers software validation to be the confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled [14]. Software validations have special concerns on software installation, implementation, and utilization. A software validation consists in several tests, inspections, and verifications performed to assure the adequate installation and use of software and that the tasks performed meet all the specifications defined. Software validations must be performed under the environmental conditions to which software will be submitted. This is particularly important in medical devices that are used under special conditions, such as close to or inside the human body. 

In the United States, revisions of the GMP regulations became effective in June 1997 under the Code of Federal Regulations, Quality System Regulation (21 CFR 820). This was the first GMP revision since 1978, and included changes to ensure that the new regulation was compatible with ISO 9000, such as preproduction design control and validation. It was felt that if quality-associ-... 

U.S. Food and Drug Administration. Medical devices current good manufacturing practice (CGMP). Fed Reg Part 820, Quality System Regulation. Rockville, MD (1996). 

From the device regulations 21 Code of Federal Register (CFR) 820.50 Quality System Regulation Subpart E—Purchasing Controls Each manufacturer shall establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, (a) Evaluation of suppliers, contractors, and consultants. Each manufacturer shall establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants. ... 

The quality systems regulations (QSR) that were codified in October 1996 for the medical device industry are more specific than the above regulations, which govern change management for pharmaceutical products. 

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