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How does FSMA 204 differ from other FSMA rules

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The Food Safety Modernization Act Rule for Food Traceability

The Food Safety Modernization Act (FSMA) represents a landmark legislation aimed at revolutionizing food safety practices in the United States. Among its various rules and regulations, the FSMA Rule for Food Traceability stands out as a pivotal measure designed to enhance the transparency and accountability of the food supply chain. This rule, designated as FSMA […]

What is food irradiation

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What is food irradiation and why is it used?

In today’s world, ensuring food safety while minimizing food waste is a paramount concern for both consumers and food producers alike. One innovative technology that addresses these challenges is food irradiation. Food irradiation involves exposing food to controlled amounts of ionizing radiation, which effectively eliminates harmful bacteria, pests, and pathogens while extending the shelf life […]

What is food defense

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What is food defense? Everything you need to know

Food defense is a critical aspect of ensuring the safety and security of the global food supply. In an era where food systems are increasingly interconnected and vulnerabilities can arise from various sources, understanding and implementing effective food defense measures are more important than ever. From intentional acts of sabotage to unintentional contamination, the threats […]

The parts included in CAPA

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What is CAPA (Corrective and preventive action)? Is it important?

In any industry, ensuring product quality and safety is always a top priority. CAPA (Corrective and Preventive Action) plays a crucial role in achieving this goal, providing an effective system to address current issues and prevent potential problems in the future. This article, GOL will delve into CAPA, including its definition, significance, and the steps […]

ISO 22000 Food Safety Management System (FSMS)

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What is FSMS? 4 Elements in Food Safety Management System

In today’s increasingly complex food industry, ensuring the safety and quality of food products is paramount. This is where a Food Safety Management System (FSMS) plays a pivotal role. An FSMS is a systematic approach to identifying, evaluating, and controlling food safety hazards throughout the entire food supply chain. By implementing an FSMS, food businesses […]

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How to comply with the 21 CFR Part 11 standard?

Complying with the 21 CFR Part 11 standard is essential for organizations in FDA-regulated industries that use electronic records and electronic signatures. This regulation ensures the integrity, reliability, and security of electronic documents and forms a crucial part of regulatory compliance. In this article, GOL Solutions will guide you through the key steps and strategies […]

What is GRAS

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What is Generally recognized as safe (GRAS)?

In food production, numerous ingredients are introduced to enhance flavors, preserve freshness, and improve appearance. While these additives offer diversity and convenience, questions arise about their safety. Generally Recognized As Safe (GRAS) designation ensures food safety by certifying substances as safe for consumption, either through scientific consensus or historical use. This article, GOL Solution delves […]

What is FURLS

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FDA Unified Registration and Listing System (FURLS)

In the realm of medical devices, adherence to regulations is non-negotiable. Enter the FDA Unified Registration and Listing System (FURLS), a pivotal tool that streamlines registration and listing procedures, fostering transparency and bolstering oversight for enhanced public health safety. As the FDA continues to refine its regulatory strategies, FURLS stands as a steadfast ally, embodying […]

The ANDA Submission Process

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What Is an Abbreviated New Drug Application (ANDA)?

ANDA (Abbreviated New Drug Applications) play a crucial role in ensuring the accessibility and affordability of healthcare. They serve as the gateway to market for generic drugs, providing consumers with more options at lower prices. In this article, GOL delves into the world of ANDAs, exploring their definition, application process, and important role in the […]

Cosmetic-Direct-2

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Cosmetics Direct: A New Era for FDA Cosmetic Registration – Elevate Your Cosmetics Brand

Cosmetics Direct: A New Era for FDA Cosmetic Registration – Elevate Your Cosmetics Brand December 18, 2023, marked a pivotal moment when the US Food and Drug Administration (FDA) unveiled the Cosmetics Direct online portal, opening doors for Vietnamese cosmetic companies to access the lucrative US market. In parallel, the FDA also released detailed guidelines […]

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