Can You Use Your Manufacturer's QMS?

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Quality Management
In this briefing, Regulatory Affairs Specialist Joel Reid discusses outsourcing production to external manufacturers and how that impacts quality management systems, or QMS.

Understanding the nuances regarding QMS is critical in ensuring the smoothest and most efficient path to market. Watch to learn more!

Can't watch right now and rather read a quick summary? Here is a recap of what Joel shares in the video:

Hello, Joel here with the team at Proxima Clinical Research.

Today we'll be talking about quality management systems or QMS and whether you need your own or can rely on your manufacturers.

There are often times when drug or device developers decide that outsourcing production to an external manufacturer is the right move for them. However, when you outsource production to a manufacturer, it can become unclear what the procedure should be for QMS.

Do you need your own QMS or can you rely on theirs?

To answer this question, it's important to consider that the FDA requires owners or operators of establishments involved in producing and distributing drugs or medical devices for use in the US to establish and maintain a quality system. In addition, to complete the annual FDA registration process, establishments must verify that they have a QMS in place to ensure that their products meet FDAs stringent quality requirements.

So yes, device and drug developers need their own QMS from the start and cannot simply outsource one from their manufacturer. But don't panic. Having a QMS does not mean taking on additional burdens. It's possible to establish a system that leverages your suppliers to your best advantages.

According to 21 CFR 820. If the company does not perform all steps in the development and manufacturing quality elements related to production controls such as production and process controls, handling, storage, distribution and calibration may be outsourced and handled by qualified suppliers. In such cases, the companies accountable for overseeing the outsourced activities to ensure compliance with the 21 CFR 820 requirements is part of its QMS. The company can accomplish this by documenting that these quality elements are being managed by a qualified contract manufacturer in its procedures.

In short, you may gear your own QMS to make it known that elements of your products lifecycle are not carried out by your company and have been relinquished to a qualified manufacturer.

This is an example of how quality management systems can be very nuanced and are typically best navigated with the help of an experienced CRO. At Proxima, our team has the knowledge and capabilities to tailor a QMS that best fits your specific needs.

See the difference a next-gen CRO can make by visiting us at