• Lokesh M. S. JSS University
  • N. Vishal Gupta JSS College of Pharmacy, Mysuru


Change is inevitable in a pharmaceutical manufacturing operation. Vendors change processes, sources, and specifications for raw materials, equipment requires repair, service, or replacement, manufacturing locations are changed, batch sizes are increased or decreased and advancements in technology are made that dictate changes to the operations. After issuing of Marketing Authorization and/or manufacturing, many changes occurs across the Product lifecycle, i.e. Scaling up of pilot batch into commercial batch and variation in manufacturing processes, excipients and manufacturing sites. All these changes are considered as post approval changes or variations. These variations need to be approved by the respective regulatory authorities of a country. If not, it puts the marketing authorization holder and/or license holder at risk. Proper management of changes is critical and proper change management reduces the risk of suspension of licenses and the warning letter from the regulatory authorities. The present review provides an industry perception on Change Control system and importance of the Quality Management System.


Keywords: Marketing Authorization, Post Approval Changes, Marketing Authorization Holder


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Author Biography

N. Vishal Gupta, JSS College of Pharmacy, Mysuru

Assistant Professor

Department of Pharmaceutics


1. Water land NH, Kowtna CC. Change control and SUPAC, in Nash RA, Wachter AH. Eds. Pharmaceutical Process Validation, Marcel Dekker, New York; 2003. p. 699, 748.
2. Quality V, Medicines E, Products H. Deviation Handling and Quality Risk Management. 2013: Available from: http://www.whoint/immunization_standards/vaccine_quality/risk_july_2013.pdf
3. Gausepohl C. Deviations–Definition and Requirements Requirements for deviation management. 2013;(10):1–3. 2014; Available from: http://www.gmp-publishing.com/media/ files/leitartikel_2013/lOGFILE-10-2013-Deviations-Definition-Requirements.pdf
4. Freeman S. Change management: a far-reaching, comprehensive, and integrated system compliance. Handbook for Pharmaceuticals, Medical Devices, and Biologics. Ed. Carmen Medina. 1st edition. Marcel Dekker, New York; 2004. p. 315-46.
5. Implementation of pharma change control. Available from: http://www.fdanews.com/ext/resources/files/The_Food_And_Drug_Letter/2013/Pharma-Change-Control-Peither-ExecSeries.pdf. [Last Accessed 15 Dec 2014].
6. Directorate-general C. European commission. 2014. Available from: http://ec.europa.eu/health/files/gmp/2014-02_pc_ draft_gmp_annex.pdf. [Last Accessed 15 Dec 2014].
7. History of Change management. 2014. Available from: http://www.prosci.com/change-management/change-management-history. [Last Accessed 15 Dec 2014].
8. Change Management. 2014. Available from: http:// www.change-management-coach.com/benefits-of-change-management.html. [Last Accessed on 20 Dec 2014].
9. GMP in production. 2014. Available from: http://ec.europa.eu/ health/files/eudralex/vol-4/pdfs-en/cap5en.pdf. [Last Accessed on 20 Dec 2014].
10. Medical devices. CFR-Code of Federal Regulations Title 21. 2014. Available from: http://www.accessdata.fda.gov/ scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=211.100. [Last Accessed on 20th Dec 2014].
11. Medical devices. CFR-Code of Federal Regulations Title 21. 2014;5–7. 2014. Available from: http:// www. accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=211.160. [Accessed on 20 Dec 2014].
12. Committee P. Working party on control of medicines and inspections final version of annex 15 to the EU Guide to Good Manufacturing Practice Title: 2001. 2014. Available from: http://ec.europa.eu/health/files/eudralex/vol-4/pdfs-en/v4an15_en. pdf. [Accessed on 20 Dec 2014].
13. Recommendations on validation master plan for non-sterile process. 2014. Available from: http://www.picscheme.org/ pdf/25_pi-006-3-recommendation-on-validation-master-plan.pdf. [Last Accessed on 20 Dec 2014].
14. Guideline for the establishment of a control procedure for technical equipment, including related utilities, computerised systems and facilities used in the manufacture of API’s. 2014. Available from: http://apic.cefic.org/pub/Guideline Technical Change Control.doc.pdf. [Last Accessed on 20 Dec 2014].
15. International Conference on Harmonization of technical requirements for registration of pharmaceutical for human use guidelines, Q 10, 2008. 2014. Available from: http:// www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q10/Step4/Q10_Guideline.pdf. [Last Accessed on 20 Dec 2014].
16. Questions and answers on post approval change management protocols use of post approval change management protocols. 2014. Available from: http://www.ema.europa.eu/ docs/ en_GB/document_library/Scientific_guideline/2012/04/WC500125400.pdf. [Last Accessed on 20 Dec 2014].
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How to Cite
S., L. M., and N. V. Gupta. “QUALITY MANAGEMENT SYSTEM IN CHANGE CONTROL AT INDUSTRY LEVEL: AN OVERVIEW”. International Journal of Pharmacy and Pharmaceutical Sciences, Vol. 7, no. 5, Apr. 2015, pp. 13-19, https://innovareacademics.in/journals/index.php/ijpps/article/view/4782.
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