09
May
Understanding risk assessment for food safety
Food safety risk assessment is a vital tool for protecting public health. It helps identify, assess, and control potential hazards in the food supply chain, preventing foodborne illnesses before they occur. As a result, ensuring food safety enhances quality and builds consumer trust. In this article, GOL will provide real-life examples of applying food safety […]
09
May
A Guide to Drug Master Files
Among the crucial steps towards FDA approval lies the creation of a Drug Master File (DMF), a comprehensive document that serves as a repository of vital information pertaining to a drug product. This detailed dossier encompasses intricate details about manufacturing facilities, production processes, active ingredients, packaging materials, and other critical aspects of the drug’s journey […]
27
Apr
FDA regulations on color additives used in the US
Color additives play a crucial role in capturing consumer attention and making food, pharmaceuticals, cosmetics, and medical devices more appealing. However, the use of color additives in these products must adhere to strict regulations set forth by the United States Food and Drug Administration (FDA) to ensure consumer safety. In this article, GOL will provide […]
27
Apr
Explaining the Differences of the 3 FDA Medical Device Classes
Success in conquering the U.S. medical device market requires a clear understanding of the FDA classification system. In this article, GOL will provide you with knowledge about the differences of FDA medical device classes: Class I, Class II, and Class III, along with the regulatory requirements and market approval pathways for each type. What are […]
26
Apr
What is FDA QSR? Differences between FDA QSR and ISO 13485
In the realm of medical device manufacturing, compliance with regulatory standards is paramount. Two key frameworks governing quality management are the Food and Drug Administration Quality System Regulation (FDA QSR) and the International Organization for Standardization (ISO) 13485. While both aim to ensure product safety and quality, they differ in scope, certification processes, and global […]
26
Apr
What is FDA 483? Important Details About FDA 483 Forms
The FDA 483 form plays a crucial role in safeguarding consumer health by ensuring that products manufactured and circulated in the US market meet strict quality and safety standards. In this article, GOL will provide you with important information about the FDA 483 form, including its contents, issuance process, response methods, and consequences of non-compliance. […]
26
Apr
FSSC 22000 – Food Safety System Certification Scheme
In the context of the food industry’s continuous growth and increasing emphasis on food safety, FSSC 22000 certification has emerged as a leading standard, providing businesses with an opportunity to affirm their position and expand their market presence. Recognized by the Global Food Safety Initiative (GFSI), FSSC 22000 is built upon the foundation of ISO […]
26
Apr
ISO 22000 Standard and Essential Information You Need to Know
Food safety is a top priority for consumers and businesses in the food industry. To ensure food safety and meet the increasingly high demands of the market, many enterprises have chosen to implement the ISO 22000 standard. ISO 22000 is a food safety management system issued by the International Organization for Standardization (ISO). This standard […]
26
Apr
What is ultra-processed food? How does it affect health?
In today’s modern food landscape, the term “ultra-processed food” has become increasingly prevalent, sparking discussions and debates about its impact on health. As we navigate through aisles lined with brightly colored packaging and seemingly endless options, it’s crucial to understand what exactly constitutes ultra-processed food and the implications it holds for our well-being. From convenience […]
26
Apr
The process of registering medical devices with the FDA
The process of registering medical devices with the FDA is a crucial step for companies looking to bring their products to market in the United States. With a healthcare landscape governed by stringent regulations and evolving standards, understanding and successfully navigating the FDA registration process is essential for ensuring compliance and facilitating market access. From […]
