Where is it Written?

Published on: 
Pharmaceutical Technology, Pharmaceutical Technology-01-02-2015, Volume 39, Issue 1

Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses how to handle staff challenges to regulation requirements


Q. Our quality assurance (QA) team organizes training sessions for staff at all levels in our organization. We include links to the various applicable regulations in the training materials provided. During the sessions, we have encountered staff that question compliance requirements in our quality system. They argue that they cannot identify applicable requirements written in the regulations. QA teams are challenged and have difficulty obtaining buy-in from the entire staff. How can we navigate their objections?

A. The good news is that your personnel are interested in regulations. This demonstrates that your protocol is successfully engaging non-QA staff on this crucial information, but clearly the contents and intent of the regulations, as well as the function of the quality unit, need further clarification.

The rules and regulations typically only specify the principles, minimum requirements, and expectations for compliance, not necessarily specific details or examples. Companies, therefore, need to interpret the regulations relevant to their business. No two companies have the exact same circumstances, and consequently, there are as many interpretations of the regulations as there are enterprises.

A company’s interpretation of the regulations is reflected in its quality system, which details the organizational structures, processes, systems, and safeguards in place to assure compliance. To assure independence of the quality unit from operations, for example, the head of quality may report to the chief compliance officer in Company A and to the CEO in Company B. While Company A may decide to sign in wet ink every page of a document (e.g., a standard operating procedure) to assure control, Company B may choose to only sign the title page and rely on other safeguards instead (e.g., unique headers and footers in the document).

Whichever approach or solution is selected, it must be compliant--and the QA department is the ultimate authority for determining how a company will implement the regulations. The quality system provides the necessary guidance to avoid regular QA arbitration. The quality system is owned and managed by the QA department, but senior management is accountable for ensuring an effective quality system is in place (1). QA staff will be intimately familiar with the regulations, guidelines, and other helpful documents from regulatory agencies or other sources. They are tasked with the responsibility of maintaining and improving the quality system in real time to ensure it reflects current good manufacturing practices.

The QA department creates the contents of the quality system by amalgamating the wealth of information, knowledge, and expertise. It comes as no surprise that there are many elements where there is no direct equivalent in the rules and regulations (2). Maybe these basic concepts have not been conveyed clearly or assertively enough. Constructive criticism should be welcomed, but obstruction or non-compliance is simply unacceptable. If all else fails, senior management will have to weigh in.

If your staff wants to know where a particular regulation is written, they needn’t look any further than your quality system.

1. EudraLex, The Rules Governing Medicinal Products in the European Union, Volume 4, Part 1, Chapter 2: Personnel, http://ec.europa.eu/health/files/eudralex/vol-4/
2. Dr. B. Renger, The Role of Quality Assurance within the Pharmaceutical Quality System, LOGFILE No. 20 (June 2014), www.gmp-publishing.com.


Article DetailsPharmaceutical Technology
Vol. 39, No. 1
Pages: 78
Citation: When referring to this article, please cite it as S. Schmitt, "Where is it Written?," Pharmaceutical Technology39 (1) 2015.