Full Circle Consulting
EMMA International can be there every step of the way for your product! From product development to helping with QMS upkeep and post-market monitoring, EMMA is here to bring your product full-circle. The expertise of the EMMA team can help you get through the biggest quality and regulatory hurdles in the life science industry with ease.
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One of the most common techniques to prevent contamination of products and reduce quality impacts in the pharmaceutical industry is called aseptic gowning. Humans are the biggest sources of microbial contamination in cleanroom environments and therefore proper gowning procedures are essential to ensuring product quality. Proper training, education, hygiene, qualification, and authorization must be put in place and be required for entry to all clean room environments...
Having high quality standards is vital to any organization but is even more essential in the pharmaceutical industry. Practices that are governed by these standards are commonly called Good Manufacturing Practices (GMP) and ensure consistent and controlled production of products. These practices govern all aspects and procedures within production and provide documented proof that procedures are consistently followed during the manufacturing processes every time products are made. They are designed to minimize risks throughout the manufacturing process that are not able to be eliminated in final product testing so that pharmaceuticals are safe for use...
Across all industries, documentation is a key aspect of maintaining good quality and traceability over products. Therefore, having good documentation practices (GDP) is an essential tool and something that requires repetitive training to ensure proficiency. Especially in the life science industries, having good documentation improves overall product quality and allows for clearer traceability and validation within processes. GDP practices can be done using the acronym, ALCOA, which stands for Attributable, Legible, Contemporaneous, Original, and Accurate.
A 510(k) is a premarket submission made to the Food and Drug Administration (FDA) by medical device manufacturers to demonstrate that their device is safe and effective for its intended use. The process is required for devices that are not exempt from premarket notification requirements. This article outlines the steps involved in obtaining a 510(k) clearance.
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