Quality Management Systems for Drugs and Devices
33
25. “A Brief History of the GMPs.” Compliance Leadership
Series. Immel Resources. http://biomanufacturing.org/uploads/
files/305429596362804820-brief-history-of-gmps.pdf.
26. A History of Medical Device Regulation and Oversight
in the United States. FDA website. https://www.fda.
gov/medical-devices/overview-device-regulation/
history-medical-device-regulation-oversight-united-states.
27. Medical Device Reporting Regulation History. FDA website.
https://www.fda.gov/medical-devices/mandatory-reporting-re-
quirements-manufacturers-importers-and-device-user-facilities/
medical-device-reporting-regulation-history.
28. 21 CFR Part 803 Medical Device Reporting. FDA website.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/
CFRSearch.cfm?CFRPart=803.
29. 21 CFR Part 806 Medical Devices: Reports of Corrections and
Removals. FDA website. https://www.accessdata.fda.gov/scripts/
cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=806. FDA website.
30. 21 CFR Part 821 Medical Device Tracking Requirements. FDA
website. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/
cfcfr/CFRSearch.cfm?CFRPart=821.
31. The Global Harmonization Task Force (GHTF) Guidance,
GHTF/SG3/N17:2008 Quality Management Systems—Medical
Devices—Guidance on the Control of Products and Services
Obtained From Suppliers. IMDRF website. http://www.imdrf.
org/docs/ghtf/final/sg3/technical-docs/ghtf-sg3-n17-guidance-
on-quality-management-system-081211.pdf.
32. Guidance for Industry: Process Validation: General Principles and
Practices. FDA website. https://www.fda.gov/files/drugs/pub-
lished/Process-Validation--General-Principles-and-Practices.pdf.
33. Overview of Medical Device Process Validation and Regulatory
Requirements. April 2019. Oriel Stat a Matrix website. https://
www.orielstat.com/blog/medical-device-process-validation/.
34. Op cit 20.
All website links were reverified in September 2021.
33
25. “A Brief History of the GMPs.” Compliance Leadership
Series. Immel Resources. http://biomanufacturing.org/uploads/
files/305429596362804820-brief-history-of-gmps.pdf.
26. A History of Medical Device Regulation and Oversight
in the United States. FDA website. https://www.fda.
gov/medical-devices/overview-device-regulation/
history-medical-device-regulation-oversight-united-states.
27. Medical Device Reporting Regulation History. FDA website.
https://www.fda.gov/medical-devices/mandatory-reporting-re-
quirements-manufacturers-importers-and-device-user-facilities/
medical-device-reporting-regulation-history.
28. 21 CFR Part 803 Medical Device Reporting. FDA website.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/
CFRSearch.cfm?CFRPart=803.
29. 21 CFR Part 806 Medical Devices: Reports of Corrections and
Removals. FDA website. https://www.accessdata.fda.gov/scripts/
cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=806. FDA website.
30. 21 CFR Part 821 Medical Device Tracking Requirements. FDA
website. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/
cfcfr/CFRSearch.cfm?CFRPart=821.
31. The Global Harmonization Task Force (GHTF) Guidance,
GHTF/SG3/N17:2008 Quality Management Systems—Medical
Devices—Guidance on the Control of Products and Services
Obtained From Suppliers. IMDRF website. http://www.imdrf.
org/docs/ghtf/final/sg3/technical-docs/ghtf-sg3-n17-guidance-
on-quality-management-system-081211.pdf.
32. Guidance for Industry: Process Validation: General Principles and
Practices. FDA website. https://www.fda.gov/files/drugs/pub-
lished/Process-Validation--General-Principles-and-Practices.pdf.
33. Overview of Medical Device Process Validation and Regulatory
Requirements. April 2019. Oriel Stat a Matrix website. https://
www.orielstat.com/blog/medical-device-process-validation/.
34. Op cit 20.
All website links were reverified in September 2021.