A quality management system, QMS,  is a crucial requirement for any organization in the life sciences industry. While the requirement to have a QMS is the same across all life sciences the requirements of what the QMS must contain will differ between the different industries within life sciences. For example, while a QMS for a medical device company would require design controls processes to be built in, a QMS for a pharmaceutical company would not have that same requirement.

A pharmaceutical QMS would have a few of the same basic requirements as any other QMS. Those requirements are:

  • Management Repsonibilities
  • Resource Management, including personnel management
  • CAPA management
  • Internal Audit

While the basics of the pharmaceutical QMS may be the same as others there are a few key differences. One such difference is the need for laboratory controls. In the pharmaceutical industry, a lab is used for the quality control checks of products. This includes testing products to ensure they meet the required specifications. Processes and procedures to govern the lab and all the testing done will need to be created as part of the QMS.

Incoming inspection is one process common to many other quality management systems, in a pharmaceutical lab, however, there are many tests more tests involved as each chemical, physical component, and label that enters the facility will need to be examined and tested. In addition, the lab will also Out-Of-Specification (OOS) processes.[1] These processes govern what to do when the testing of a finished product testing comes back out of the proper ranges, i.e. out-of-specification.

The creation of a quality management system is challenging. There can be a lot of confusion about which processes are actually required per regulations. A proper QMS should be able to grow and adapt to the needs of the company. EMMA International’s team of experts are capable of developing a QMS that perfectly matches the needs of the company. EMMA International provides Full Circle Consulting services, give us a call at 248-987-4497 or email us at info@emmainternational.com to get in touch with our team of experts today.

[1] FDA (November 2014) Pharmaceutical Quality Control Labs (7/93), Retrieved 03/26/2022 from https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-guides/pharmaceutical-quality-control-labs-793

Gabe Kadoo

Gabe Kadoo

Mr. Kadoo is a Quality Engineer at EMMA International. He has experience in statistical analysis, performance improvement, quality assurance, and value stream mapping in the clinical setting. Mr. Kadoo also has experience as a clinical researcher and medical technologist. Mr. Kadoo holds a Bachelor of Science in Biology and a Master of Public Administration with a concentration in Healthcare Administration. He is also a Six Sigma Green Belt.

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