Navigating MoCRA Compliance: Ensuring Your Laboratory Partner is Prepared

Is your laboratory testing partner ready for MoCRA?

Cosmetics manufacturers around the globe have been busy registering their facilities with the United States Food & Drug Administration (FDA) as required by the Modernization of Cosmetics Regulations Act (MoCRA). Did you know that contract laboratories also need to register?

While it has been a hotly debated topic for the past year or so, the FDA released its final draft guidance which indicates that, if they perform “cosmetic product batch release testing,” a laboratory is considered part of the manufacturing process, and therefore, they need to register as facilities under MoCRA.

Q Labs has long been registered with the FDA for drug testing (FEI: 152760), and we are proud to announce that we have expanded the scope of our registration to include cosmetic testing, to continue to support our valued cosmetic clients. Per our FDA registration, we are now required to gather all the required brand information from our clients to comply with MoCRA. We have been diligently working to gather this information and anticipate the final registration to be completed in March.

What do you need to do as a cosmetic manufacturer?

As a cosmetic manufacturer, you are responsible for ensuring that your laboratory partner is appropriately qualified, including maintaining any required registrations. If you currently outsource or plan to outsource quality control testing of your cosmetic products to an external laboratory, you need to ensure that your laboratory partner is properly registered with the FDA.

You should also make sure that your laboratory partner has experience working with regulatory agencies, including hosting inspections. It is also important that they be competent and equipped to stay up to date on changing regulations. This is particularly important with MoCRA as draft Good Manufacturing Practices, guidance documents, and various other MoCRA-related items can be expected to be rapidly evolving over the coming years.

How can Q Labs help?

Q Labs has extensive knowledge and experience evaluating cosmetic products including chemistry, microbiology, and stability testing. We are excited to combine our cosmetic testing experience with our regulatory expertise to support your company as you grow. All our employees are trained in drug GMPs, as well as what have historically been “best practices” for cosmetics. As such, Q Labs is exceptionally positioned to help our clients maintain compliance in their quality control testing while navigating the MoCRA landscape.

Outside of laboratory testing, Q Labs is also proud to offer assistance with gap analysis and working toward compliance with MoCRA through Q Labs Consulting LLC. Whether it be GMP training, mock audits, mock recalls, right-sizing testing programs, developing validation protocols, or simply having experts to discuss questions, our scientists and regulatory experts stand ready to assist you as you work towards MoCRA compliance.

Later this spring Q Labs will also be hosting an online webinar, to provide further information and answer any questions about MoCRA. We have also built an easy-to-use tool for current clients to provide us with the required cosmetic brand updates in real-time.

Stay tuned for more information!