References
- GHTF/SG3/N99-10, quality management systems – process validation guidance; January 2004. [cited Jun 3]. http://www.imdrf.org/docs/ghtf/final/sg3/technical-docs/ghtf-sg3-n99-10-2004-qms-process-guidance-04010.pdf
- Yeong-Lin Chen. Medical device process validation: what we can borrow from pharmaceutical process validation guidance. J Valid Technol. 2019;25. Available from: http://www.ivtnetwork.com/article/medical-device-process-validation-what-we-can-borrow-pharmaceutical-process-validation-guida
- FDA Guidance for industry, process validation: general principles and practices; January 2011. [cited Jun 3]. Available from: http://www.gmp-compliance.org/guidemgr/files/UCM070336.PDF
- EU guidelines for good manufacturing practice for medicinal products for human and veterinary use, Annex 15: qualification and validation; March 2015. [cited Jun 3]. Available from: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/2015-10_annex15.pdf
- PIC/S. Recommendation on validation master plan, installation and operational qualification, non-sterile process validation, cleaning validation; September 2007. [cited Jun 3] Available from: https://www.picscheme.org/layout/document.php?id=152
- General principles of software validation; final guidance for industry and FDA staff; January, 2002. [cited Jun 3]. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-principles-software-validation