OTC Drug GMP Process Certification to NSF/ANSI 455-4 – 2024
Looking for GRMA NSF/ANSI 455-4 for OTC Drugs certification? Check out the details here.
Over-the-counter (OTC) drug manufacturing increasingly requires third party certification to meet retail requirements. Regardless of mandates, certification always remains an excellent means to demonstrate commitment to quality by your company and to distinguish your brand from competitors. Eurofins Assurance now offers GMP certification to NSF/ANSI 455-4 to meet this need.
In the U.S. market, NSF/ANSI 455-4 – 2024 has been developed as a public standard by the industry, retailers and users of this standard to Represent best practices in OTC drug manufacturing meeting retailer expectations for quality.
Certification requirements of ANSI/NSF 455-2024
Certification to ANSI/ NSF 455-4 – 2024 includes 21 CFR Part 210 & 211, 21 CFR Part 11, 21 CFR Part 7 Subpart C, and ICH Q1, Q7, & Q10.
This standard is organized into a quality systems approach based on ISO principles and US GMP regulations 21 CFR 210/211. Like all Eurofins Assurance GMP certifications, this is both a quality management system and scope-based process certification evaluating all product types and significant manufacturing technologies active at the site while in production against all of the technical requirements of the standard, ensuring full implementation of drug GMPs throughout the manufacturer’s capabilities.
Certification to this standard provides assurance to your customers of your commitment to quality and continuous improvement, and is widely recognized by retailers and brands.
A GMP certificate of conformity and the Eurofins Assurance certification marks are issued to the company after all program requirements are met and the company can market its certification to its customers and distinguish itself from competitors.
ANSI/NSF 455-4 – 2024 GMP certification process overview
To initiate the certification process, Eurofins will collect detailed information about your company’s manufacturing sites, including some pre audit documentation to ensure preparedness and proper audit scope and duration is agreed.
The audit duration is based upon the scope and complexity of the operation but is usually 3 or more days for a single manufacturing location.
Eurofins Assurance OTC Drugs ANSI/NSF 455-4 – 2024 GMP Process Certification Documentation
Manufacturers who meet all certification requirements receive a GMP Certificate of Conformity issued by Eurofins Healthcare Assurance.
Companies are also licensed to use and display the Eurofins OTC Drugs ANSI/NSF 455-4 – 2024 Certification Mark on corporate marketing materials to communicate the achievement and highlight the company commitment to quality and continuous improvement.
Please refer to the Policies and Procedures for Good Manufacturing Practices (GMPs) and Management Systems Certification. The certification is conducted by Eurofins Assurance Audit and Certification Services US, LLC and the Terms & Conditions can be viewed here.
Why choosing Eurofins for your OTC drugs certification
With experts in the US and around the world, the Eurofins Assurance team possesses strong expertise in drug manufacturing certification and ANSI/NSF 455-4 – 2024. Our team are third party conformity assessment experts and leverage the most experienced, well-trained auditors located globally to support customers with geographic proximity.
Our certification activities are provided by independent companies and separate from consulting activities. Such services are also presented and sold to clients separately, not in bundle or packaged format. Impartiality is safeguarded by Eurofins Assurance’ relevant policies to avoid conflicts of interest.
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