FDA Compliance

Following any tech transfer project, the subsequent startup of the manufacturing line is almost always full of challenges.

In regulated industries, every step of the production process must be verified to some sort of guidance or standard. What this comes down to, practically speaking, is an enormous amount of time and effort spent on actions outside the sphere of production.

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To meet increasingly strict compliance standards, such as the Food Safety Modernization Act (FSMA) and Global Food Safety Initiative (GFSI), food processors now regularly use adenosine triphosphate (ATP) testing to monitor equipment surfaces for microbial growth.

Medical-device usability testing and validation are critical tasks leading up to a medical device’s debut on the market. “Usability” looks at how the user interacts with your device and forms a key component of overall risk management and safety.

Food manufacturers must carry out numerous specific processes to check that the foods they produce and distribute are safe for consumers. Analytical testing plays a vital role in meeting that goal.

During the past year, the U.S. Food and Drug Administration’s (FDA) approach to foreign and domestic inspections for food and medical products has been both risk-based and deliberate.

There are many important issues to be considered in the food industry, such as consumer tastes, environmental impact, and economic aspects, but the most important is food safety.

Never have we been more acutely aware of the importance of reliability when it comes to laboratory testing. As the ongoing Covid-19 pandemic has highlighted, the development of accurate diagnostic tests plays an important role in outbreak management.