Covering Global Pharmaceutical Regulations in a Quality System

  • Siegfried Schmitt univ

Abstract

This article describes how to address compliance with a wide range of applicable regulations within a company’s quality system. The focus is on the way regulatory intelligence can be obtained and subsequently be interpreted within the quality system. Roles and responsibilities of those involved are also discussed.


Regulatory agencies try to harmonise regulations regionally and to some extent globally, but that still requires a lot of work. To remain up-to-date with the Good Practices, i.e. remain in a continued state of compliance, one needs to be aware of the regulations, interpret their impact on the quality system and operations, and if necessary, then change, adapt and improve these. This process is a continuous improvement process cycle in Pharmaceutical Industries (1).

Keywords: Quality system, regulatory intelligence, QMS, SOP, data integrity (DI), SME.

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References

1. Schmitt S. Covering Global Regulations in a Quality System. Pharmaceutical Technology. 2017 Mar 02; 41(3):106.
2. US FDA. CFR - Code of Federal Regulations Title 21 [Internet]. US FDA; 2018 Apr. 09 [cited 2018 Jun 12]. Available from:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=210
3. US FDA. CFR - Code of Federal Regulations Title 21 [Internet]. US FDA; 2018 Apr. 09 [cited 2018 Jun 12]. Available from:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=211
4. ICH. Quality Risk Management Q9 [Internet]. ICH; 2005 Nov. 09 [cited 2018 Jun 17]. Available from:
https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q9/Step4/Q9_Guideline.pdf
5. Badjatya J, Bodla R. Harmonization & advancement in Pharmaceutical industry. International Journal of Drug Regulatory Affairs [Internet]. 2018 Feb. 06 [cited 2018 Sep 12]; 1(2):7-10. Available from:
http://ijdra.com/index.php/journal/article/view/4
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How to Cite
Schmitt, S. “Covering Global Pharmaceutical Regulations in a Quality System”. International Journal of Drug Regulatory Affairs, Vol. 6, no. 3, Sept. 2018, pp. 1-4, doi:https://doi.org/10.22270/ijdra.v6i3.257.