Regulatory inspections from the FDA are often nerve-wracking for a manufacturing company and its employees. An inspection can come along at any time, which is why you must be fully prepared for the possibility in order to perform well. The FDA wants to know that there are systems in place that allow your company to show exactly what is going into its manufacturing processes and that you are working to make things better if they are not yet perfect. Read more »
New legislation was introduced in January of 2015 which seeks to change the way a new drug will be defined and, eventually, the amount of manufacturers interested in creating combination drugs. As a combination manufacturer, you will need to know how this specific legislation will affect you and how new combination drugs will be defined as well as how other companies may receive incentives to start manufacturing these products. Read more »
In January 2015 the FDA issued a new draft guidance document regarding the final rule on current good manufacturing practice requirements (cGMP) for combination products that was issued on January 22, 2013 and made effective on July 22, 2013. The guidance describes and explains the final rule, so it is important for all combination product manufacturers to understand the most influential topics that were covered. Read more »
For medical manufacturers, compliance with the FDA regulations is paramount, as the device or product itself as well as the manufacturing process must all meet these specific standards. With the rise in mobile medical apps in the past few years, there is a growing concern about the FDA’s regulation of these devices, and it is important for all manufacturers to understand which apps are to be regulated, why, and how. Read more »
Biomanufacturing is a difficult process, as anyone who works in the field understands, and there continues to be a great need for the work of biomanufacturing to become less expensive, more streamlined, and all around less problematic for biologics manufacturing companies. Understanding why biomanufacturing is so difficult and getting to the root of the problem can help change the process for the better and make it much more reliable for your company. Read more »
For your pharmaceutical company, reducing operating costs and improving service are possible with a large-scale supply chain transformation. While this kind of extensive reworking of your supply chain may seem intimidating and unnecessary, it can help make your company’s costs smaller, its reach greater, and its manufacturing needs more streamlined which will, in turn, positively affect your company as a whole. Read more »
For medical device managers, it is that time of the year when precautions should be especially considered. Medical products have international standards which must be complied with if these devices are to be internationally used and shipped. Most importantly, understanding and complying with ISO 14971 and its most recent version is necessary, and you must be prepared to lead your team in a risk evaluation that follows these standards. But first, what are the standards of the ISO 14971:2012 exactly, and what is it all about? Read more »
According to RAPS, the new 510(k) ruling by FDA details “how regulators will evaluate applications in order to determine ‘substantial equivalence.'” In the past, medical device manufacturers were able to reference separate but similar devices or products (called predicate devices) that had already been marketed in order to assess the safety of their new device. Read more »
In the business of medical device manufacturing, validating the cleaning process of products is a top priority. You must always ask yourself the two most important questions: will the device be safe for the patient, and will it continue to function properly? If it is not cleaned thoroughly during its production, it could be an issue. Consider these useful tips for validating your cleaning process to help ensure your medical device products will be safe and effective. Read more »
The recent drug recall surge from the FDA has been somewhat staggering. According to RAPS, “2014 is already shaping up to be the biggest year for serious drug recalls in the last decade.” The total number of drug recalls so far almost surpasses that of 2013, which in itself was extremely high. With the year not over yet, 2013 and 2014 could see more recalls than the previous nine years combined. Read more »
