We’re using the ANSI standards development process to develop consensus-based auditing standards for dietary supplements, medical devices, over-the-counter drugs and cosmetics/personal care products.
The GRMA is developing a standard for dietary supplements based on 21 CFR Part 111 and relevant criteria from 21 CFR Part 117 (Food Safety Modernization Act) for the production, control, storage and shipment of dietary supplement products.
The GRMA is developing a standard for cosmetic and personal care products based on ISO 22716 and the U.S. FDA Cosmetic GMP Guidance for the production, control, storage and shipment of cosmetic products.
The GRMA is developing a standard for OTC drugs based on GMPs for manufacturing, processing, packing or holding drugs for finished pharmaceuticals (21 CFR Parts 210 and 211). The standard may also include parts of the only standard for GMPs in pharmaceutical excipients, NSF/IPEC/ANSI 363.
The GRMA is using the American National Standards Institute (ANSI) approved GMP standard, ANSI/AAMI/ISO 13485, as the basis to create a consensus-based audit program for medical devices.
Through the development of a single, public standard for each product category that all certification bodies can use, industry will be able to utilize their certification to meet multiple customer and retailer needs.
Retailers and manufacturers can point to the ANSI-approved GMP standards as proof of the industry’s commitment to quality, safety and regulatory compliance.
The GRMA is addressing universally supported objectives that retailers and manufacturers have been seeking. The new, ANSI-approved auditing standards are designed to:
- Protect consumer health and safety
- Provide better risk management programs and protect store brand integrity
- Improve the efficiency of retailer/manufacturer interactions
- Create a single audit report that is accepted by all participating retailers
- Create consistency through auditor qualification, training and calibration requirements
- Reduce the number of audits required by retailers
- Reduce manufacturer audit costs (both time and money)
- Give manufacturers time to address continuous improvement
The standards are expected to be completed throughout 2017, with the Dietary Supplement GMP standard completing first, followed by Cosmetics, OTC drugs and Medical Devices. Once finalized, the new ANSI-approved standards will combine regulatory GMP requirements and retailer requirements. This will strengthen safety, quality and trust throughout the supply chain while also reducing audits, lowering auditing costs and ensuring consistency and proper training of auditors.