Ensuring consumer safety and regulatory compliance for OTC drugs, cosmetic products, and dietary supplements

Laurianne Kandalaft, Eurofins Assurance, lauriannekandalaft@eurofins.com

Ensuring consumer safety and regulatory compliance is a constant and key requirement for retailers and manufacturers of healthcare products all over the world. Safety and regulatory risks are mitigated thanks to regular audits of sites, which sometimes leads to a high burden for suppliers and manufacturers, who can have several dozen audits to handle each year.

Trying to address this complexity, several retailers, manufacturers, key industry associations, and regulatory bodies have united in order to form the Global Retailer and Manufacturing Alliance (GRMA) in 2014.

GRMA’s aim is to enhance consistency and harmonisation across quality management systems of the dietary supplement, cosmetic, and over-the-counter (OTC) drug industries. For this, the alliance brings together the requirements of top retailers, manufacturers, and industry associations under one unique standard. The result is a GRMA certification programme, using a single, publicly accredited GMP standard, and covering three health and wellness product categories, which are: OTC drugs, cosmetics, and dietary food supplements.

For suppliers and manufacturers, the advantage of being certified by GRMA is that all members of the alliance will have access to the audit report. This allows a significant reduction of the number of audits to handle by one site and ultimately reduces associated costs.

Eurofins Assurance in the US is proud to become an authorised GRMA Certification Body (CB) and to be able to provide audits to suppliers of members of the alliance and ultimately improve GMP compliance. Our audit team has already begun the process to achieve full approval and accreditation to the GRMA’s OTC Drugs, Dietary Supplements, and Cosmetics certification programme.

Eurofins Assurance experts and auditors have demonstrated excellent understanding of the standard’s criteria, completed required trainings, and showed proficiency in conducting GRMA audits. These audits can be done on sites anywhere in the world thanks to our extensive global network of auditors, which includes experts of the healthcare, food, and cosmetic industries. For more information, visit: www.eurofins.com/GRMA