References
- Chen Y-L. Two-level process validation approach for medical devices. J Med Eng Technol. 2019;43(2):139–149.
- FDA guidance for industry, process validation: general principles and practices; January 2011. Available from: https://www.fda.gov/media/71021/download
- GHTF/SG3/N99-10, quality management systems - process validation guidance; January 2004. Available from: http://www.imdrf.org/docs/ghtf/final/sg3/technical-docs/ghtf-sg3-n99-10-2004-qms-process-guidance-04010.pdf
- Katz P, Campbell C. FDA 2011 process validation guidance: process validation revisited. J GXP Compliance. 2012;16(4):18–29.
- PIC/S. Recommendation on validation master plan, installation and operational qualification, non-sterile process validation, cleaning validation; September 2007. Available from: https://www.picscheme.org/layout/document.php?id=152
- 21 CFR Part 820, medical devices - quality system regulation QSR; April 2019. Available from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820
- ISO 2859-1, Sampling procedures for inspection by attributes - Part 1: sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection; 1999. Available from: https://www.iso.org/obp/ui/#iso:std:iso:2859:-1:en
- ANSI/ASQ Z1.4, Sampling procedures and tables for inspection by attributes, 2003. Available from: https://asq.org/quality-resources/z14-z19
- ISO 3951-2, Sampling procedures for inspection by variables — part 2: general specification for single sampling plans indexed by acceptance quality limit (AQL) for lot-by-lot inspection of independent quality characteristics, 2013. Available from: https://www.iso.org/standard/57491.html
- ANSI/ASQ Z1.9, Sampling procedures and tables for inspection by variables for percent non-conforming, 2003. Available from: https://asq.org/quality-resources/z14-z19
- EU Guidelines for good manufacturing practice for medicinal products for human and veterinary use, annex 15: qualification and validation; March 2015. Available from: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/2015-10_annex15.pdf