[This article pertains to nonclinical laboratory studies.]

 

Suppose you were just hired in a Quality role (QA specialist, tester, auditor, inspector, reviewer, technical data specialist, etc.). During your orientation and training people bandy about such acronyms and initialisms as the GLPs, the OECD, the QAU, and 21 CFR 58.

 

You probably have questions. Are you supposed to know all these regulations and guidance documents in addition to training on your organization’s protocols and standard operating procedures? Not to mention the underlying science of the testing your company does? What is the history of this kind of role? Where does your role fit in with the overall business and with the science and technology going on around you?

 

First, take a deep breath and remind yourself that you don’t need to figure it out on your own. This article will give you an overview of the QAU from the United States regulatory perspective, the international guidance, and some organizational particulars. Finally, you’ll find links to help you learn further on your own.

US FDA regulations

Take a few minutes to read the Quality Assurance Unit (QAU) section of 21 CFR 58. Do it. It’s several concise paragraphs that are free of jargon:

 

(https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=58.35)

 

What you find is that the QAU is one of three very important groups of personnel defined in the regulations:

 

• Test facility management
• The study director
• The QAU

 

The section on the QAU is the lengthiest of the three.

 

Five things stand out. The QAU:

 

1. Monitors each study to assure management that facilities, equipment, personnel, methods, practices, records, and controls are in conformance with the regulations in this Part.
2. Inspects each nonclinical laboratory study at intervals adequate to assure the integrity of the study.
3. Determines that no deviations from approved protocols or standard operating procedures were made without proper authorization and documentation.
4. Reviews the final study report to assure that the methods and results are true to the standard operating procedures and raw data.
5. Prepares and signs a statement to be included with the final study report which specifies the dates inspections were made and findings reported to management and to the study director.

 

Scanning the above for keywords, you see such action terms as monitoring, inspecting, reviewing, and reporting, all of which you will do as a Quality professional.

 

Consider this a touchpoint. As you learn and grow in Quality and come take on decisionmaking responsibilities, revisit 21CFR58 occasionally. Read the Guidance for Industry document (linked below) for questions raised by other professionals and answers provided directly by the FDA.

International guidance

The Organisation for Economic Co-operation and Development (OECD) is not a governmental body, but it is composed of representatives of governments.

 

The OECD published their own GLPs, and these align for the most part with the FDA regulations. Foreign governments can hold organizations to these OECD standards. Reading them can provide you with an international perspective on the sometimes jargon-filled US regulatory environment.

 

Some individual differences between the FDA and the OECD GLP requirements regarding the QAU follow:

• There is more specific language on how the Quality Assurance Programme should be carried out by individuals designated by and directly responsible to management and who are familiar with the test procedures.
• There is more specific language on how there must be clear lines of communication in a multi-site study between the Study Director, Principal Investigator(s), the Quality Assurance Programme and study personnel.
• There is language on ensuring that the Quality Assurance personnel have a copy of the study plan and any amendments in a timely manner and that the study director will communicate effectively with the Quality Assurance personnel as required during the conduct of the study.

Particulars of an organization

How your organization meets these QAU requirements will vary quite a bit.

 

Take the example of “inspecting the study.” You may decide that every study gets inspected at an interval of one week. You might decide that these inspections will occur during critical phases such as preparation or dosing, where mix-ups and mistakes are highly consequential.

 

The reporting of the inspection to the study director and management could be a paper form, or an online tracking system. You may decide that only deviations from the protocol get reported. Or you may inspect the raw data accumulated so far very thoroughly, with the goal of finding and fixing problems as far upstream as possible.

 

After getting comfortable with your procedures, you might all of a sudden have an executive, Lean project team, or consultant come in who brings new ideas and revolutionizes the way you do things.

 

Although the particulars may vary, every company is under constant pressure from regulators, clients, and their own leadership to improve their QAU’s effectiveness and continue the upward spiral of quality.

New Quality software and other techniques

Your QAU will use third-party software to do its job. Some examples of quality management software include:

• MasterControl
• uniPoint Quality Management
• TrueERP
• QT9 Quality Management
• Verse Solutions

 

This list will only grow. You will need to master one, two or more of these systems at the user level. You may need to train others in your organization in how to use them. You may need to work closely with the software vendor to get the specific functionality your organization needs. Finally, as you gain decisionmaking authority, you will need to be a smart buyer and decide which quality management software is worth the price.

What next?

The particulars of the QAU are constantly changing as business and technology change. But the underlying principles of independence, inspection, thorough review, documentation and reporting will remain the same. Some of the GLP regulations we follow go back to 1979. But the software we use to assure quality may have just been invented a year ago.

 

Be prepared to continually question the way your QAU operates and grows with the rest of the organization. As always, if you found this article insightful (or found it to be the opposite), let me know!

Some further reading

Read about the astonishing scientific fraud scandal that led to the development of the US GLP regulations:

(http://planetwaves.net/contents/faking_it.html)

 

FDA 21CFR58, Good Laboratory Practice for Nonclinical Laboratory Studies

(https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=58)

 

FDA Comparison Chart of FDA and EPA Good Laboratory Practice (GLP) Regulations and the OECD Principles of GLP

(https://www.fda.gov/ICECI/EnforcementActions/BioresearchMonitoring/ucm135197.htm)

 

FDA Guidance for Industry Good Laboratory Practices Questions and Answers

(https://www.fda.gov/downloads/ICECI/EnforcementActions/BioresearchMonitoring/ucm133748.pdf)

 

OECD Quality Assurance and GLP guidance

(http://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=env/jm/mono(99)20&doclanguage=en)