Quality System for a Regulatory Affairs Department

Published on: 
Pharmaceutical Technology, Pharmaceutical Technology-07-02-2016, Volume 40, Issue 7

Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses standard operating procedures for the regulatory affairs department.

Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses standard operating procedures for the regulatory affairs department.

Q: Our company’s quality unit performs internal audits of all departments that have to comply with healthcare regulations. During a recent internal audit of the regulatory affairs (RA) department, we noted that there were no standard operating procedures (SOPs) in place. The RA department has asked for our help and would like to know which SOPs they will have to create and follow. What advice can you give?

A: The RA department must embed SOPs within a quality management system and create a quality unit responsible for maintaining it. RA departments perform activities that play a critical role in assuring product quality and patient health. Activities include preparing submissions (e.g., new drug applications or variations), label management, and pharmacovigilance. Regulatory authorities typically inspect RA departments because of complaints, recalls, or other non-conformance factors.

In terms of implementation, many companies will create a central regulatory affairs unit (e.g., RA headquarters) with supporting RA departments distributed across other locations. These are typically referred to as affiliates. The SOPs listed in Table I are typically associated with the RA headquarters, whereby those listed in Table II are typically adopted by the RA affiliates.


To sum up, controlled and documented processes assure compliance with the regulations, enhance the quality of all deliverables, and ultimately assure patient safety. For that reason, RA departments need to create, adopt, and implement the SOPs that cover their regulated activities. 

Article DetailsPharmaceutical Technology
Vol. 40, No. 7
Pages: 73–74

When referring to this article, please cite it as S. Schmitt, “Quality System for a Regulatory Affairs Department," Pharmaceutical Technology 40 (7) 2016.