ISO 9001:2015 Versus ICH Q10 — A Comparison

References

1. 1.↵
   International Conference for Harmonisation. ICH Harmonised Tripartite Guideline Q10: Pharmaceutical Quality System, current step 4 version, dated 4 June 2008. https://database.ich.org/sites/default/files/Q10%20Guideline.pdf (accessed April 6, 2020).

   Google Scholar
2. 2.↵
   International Organization for Standardization, ISO 9001:2008 Quality Management Systems—Requirements. ISO: Geneva, 2008.

   Google Scholar
3. 3.↵
   International Organization for Standardization, ISO 9001:2015 Quality Management Systems—Requirements. ISO: Geneva, 2015.

   Google Scholar
4. 4.↵
   International Organization for Standardization, ISO 9001:2015 Quality Management Systems—Fundamentals and Vocabulary. ISO: Geneva, 2015.

   Google Scholar
5. 5.↵
   1. Calabrese R.,
   2. Trotter A. M.,
   3. Foo L. T.

   Finding Common Ground with ISO 9001 and FDA Good Manufacturing Practices. Quality Digest [Online] 2008, March, https://www.qualitydigest.com/mar08/articles/05_article.shtml (accessed May 14, 2019).

   Google Scholar
6. 6.↵
   U.S. Food and Drug Administration. Guidance for Industry: Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations, 2016. FDA Web site. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/quality-systems-approach-pharmaceutical-current-good-manufacturing-practice-regulations (accessed May 20, 2019).

   Google Scholar
7. 7.↵
   U.S. Food and Drug Administration. Department of Health and Human Services. [Docket No. 2007D-0266] International Conference on Harmonisation; Draft Guidance on Q10 Pharmaceutical Quality System. Fed. Regist. 2007, 72 (134), 38604–38605. https://elsmar.com/elsmarqualityforum/attachments/fed-register.pdf (accessed May 14, 2019).

   OpenUrlGoogle Scholar
8. 8.↵
   International Conference for Harmonisation. Final Concept Paper Q10: Pharmaceutical Quality Systems, ICH: Geneva, 2005 https://database.ich.org/sites/default/files/Q10%20Concept%20Paper.pdf (accessed May 17, 2019).

   Google Scholar
9. 9.↵
   Food and Drug Administration. Department of Health and Human Services. [Docket No. FDA–2007–D–0370] (formerly Docket No. 2007–D–0266) International Conference on Harmonisation; Guidance on Q10 Pharmaceutical Quality System; Availability. Fed. Regist. 2009, 74 (66), 15990–15991. https://www.fda.gov/media/71553/download (accessed April 6, 2020).

   OpenUrlPubMedGoogle Scholar
10. 10.↵
    European Commission, EudraLex—The Rules Governing Medicinal products in the European Union, Volume 4: Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, Part III: GMP Related Documents. https://ec.europa.eu/health/documents/eudralex/vol-4_en (accessed April 6, 2020).

    Google Scholar
11. 11.↵
    International Organization for Standardization, ISO 9001:2008 to ISO 9001:2015: Summary of Changes, 2017. https://www.sciqual.com.au/sites/default/files/iso_9001-2015_summary_of_changes_from_9001-2008.pdf) (accessed April 6, 2020).

    Google Scholar