Developing a QMS in an FDA-Regulated Industry

by | Feb 5, 2021 | Compliance, FDA, QMS, Quality, Quality Systems, Standardization

No matter what scope your product falls under (medical device, drug, biologic, IVD) the regulatory requirements for your Quality Management System are strict. The FDA established its various Codes of Federal Regulations to enforce that a QMS is not just a “nice-to-have” for the life-science industry, it is the law. To me, however, a QMS should do more than just check a box for the FDA. Your QMS should be optimized towards your actual operations, to ensure it fulfills its purpose of supporting the several GxP standards, and ultimately facilitates your organization in creating safe and effective products.

A simple Google search would show you an abundance of options for off-the-shelf QMS’s. These are usually advertised as a full suite of ready to implement procedures that are compliant with an array of regulatory requirements and international standards. While these procedures may check the box of compliance, assuming they actually are compliant with the regulations, I have seen numerous instances of these off-the-shelf QMS’s causing more headaches for firms. The main reason is that the FDA tells you what to implement, but not how to implement it. So, for example, when you purchase a CAPA procedure you are stuck with whatever the author of that procedure thinks you should do in a CAPA process, without considering your firm’s actual scenario. If that CAPA procedure is too strict you could run into “death by CAPA”, if the procedure is not strict enough you could be letting serious quality issues go unnoticed.  To use the Goldilocks Principle, your QMS must be “just right”, otherwise you will run into serious compliance issues.

So, how do you develop an optimized QMS? It starts by having a thorough understanding of your product and which regulatory requirements and international standards applicable to it. Once you have that you need to start developing your procedures, the framework of your QMS. Developing a QMS infrastructure takes a balance of both understanding the previously mentioned requirements, and how your organization applies them. A review of the citation sources for 483’s that the FDA issued in FY 2020 shows you that most are due to “lack of or inadequate procedures”.1 While developing documentation seems fairly straightforward, there are a lot of ways you can fall into the trap of “inadequate” procedures.

Developing a QMS in an FDA-regulated industry is not always for the faint of heart. It takes not only a complete understanding of the regulatory requirements and international standards but also an alignment with your organization’s processes. EMMA International has helped countless clients by supporting their QMS development with our proprietary methodology, CLIC®. Our team of experts has experience both developing QMS’s from the ground-up and assisting firms in QMS remediation efforts. If you need help developing, implementing, optimizing, or maintaining your QMS, EMMA International is available 24/7. Call us at 248-987-4497 or email info@emmainternational.com to get connected with our team of experts today!


1FDA (Nov 2020) Inspection Observations retrieved on 02/02/21 from: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/inspection-observations

 

Madison Green

Madison Green

Director of Technical Operations - Mrs. Green serves as EMMA International’s Director of Technical Operations. She has experience in technical writing, nonconforming product management, issue evaluations, and implementing corrective and preventative actions in the pharmaceuticals and medical device industries. She has experience cross-functionally between R&D, lean manufacturing operations, and RA compliance. Mrs. Green also has academic and work experience with human health-risk engineering controls, physiological biophysics, and clinical research. Mrs. Green holds a Bachelor of Science in Biosystems Engineering with a concentration in Biomedical Engineering from Michigan State University. She is also a Certified Quality Auditor (CQA), and is currently pursuing her M.S. in Quality Management.

More Resources

Change Management And Control

Change Management And Control

One of the biggest and most important aspects of quality management is a system to monitor changes and how they impact the product. Change management is an approach for changing processes or products in a way which adheres to regulatory standards by ensuring stability and consistency throughout processes. It applies across all changes within a process and throughout an entire products life cycle.
Aseptic Technique and Gowning

Aseptic Technique and Gowning

One of the most common techniques to prevent contamination of products and reduce quality impacts in the pharmaceutical industry is called aseptic gowning. Humans are the biggest sources of microbial contamination in cleanroom environments and therefore proper gowning procedures are essential to ensuring product quality. Proper training, education, hygiene, qualification, and authorization must be put in place and be required for entry to all clean room environments...
Importance of Pharmaceutical GMP

Importance of Pharmaceutical GMP

Having high quality standards is vital to any organization but is even more essential in the pharmaceutical industry. Practices that are governed by these standards are commonly called Good Manufacturing Practices (GMP) and ensure consistent and controlled production of products. These practices govern all aspects and procedures within production and provide documented proof that procedures are consistently followed during the manufacturing processes every time products are made. They are designed to minimize risks throughout the manufacturing process that are not able to be eliminated in final product testing so that pharmaceuticals are safe for use...

Ready to learn more about working with us?

Pin It on Pinterest

Share This