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A ‘CS’ was to be a ‘Common Specification,’ intended to satisfy the EU MDR requirements. If you were working to comply with the EU’s Regulation on in vitro Diagnostic Medical Devices ((EU) 2017/746)2, or EU IVDR, the equivalent to a CS was referred to as a ‘CTS’ (“Common Technical Specification”).
What makes teams successful, based upon a study of employees working within process improvement teams for each of six large corporations, led to a list of approaches for achieving organizational quality, albeit one improvement project at a time. When I parsed these lists together with a focus upon leadership to achieve organizational quality, I was able to place the key concepts into the seven categories listed below.
Coronavirus (COVID-19) has been prevalent in the United States for over 2 years, on July 6th, the Food and Drug Administration (FDA) modified the Emergency Use Authorization (EUA) for Paxlovid for COVID-19 treatment. Paxlovid is a co-packaged, nirmatrelvir tablet and ritonavir tablet for oral use to assist with the treatment of COVID-19 in adult and pediatric patients with positive SARS-CoV-2 testing1. The nirmatrelvir inhibits the SARS-Cov-2 protein to stop the virus whereas the ritonavir slows down the breakdown of nirmatrelvir to help it remain in the body for a longer period.
If you are a drug manufacturer in the US, an Annual Drug Product Review (ADPR) should be familiar to you. ADPRs are exactly what they sound like – an annual review of your drug product based on product batch and product yield, customer complaints, recalls, stability data, and validation data just to name a few. ADPRs should be performed in order to maintain compliance with 21 CFR 211.180 and to be in alignment with the FDA’s Guidance for Industry, Q7A GMP for Active Pharmaceutical Ingredients.[1]
When reporting an Adverse Event to the Food and Drug Administration (FDA) the best method is to utilize the FDA Adverse Event Reporting System (FAERS). FAERS is a database that contains adverse event reports, product quality complaints that led to an adverse event, and medication error reports1. All FAERS reports are easily accessible to the public.
A device can be registered for the De Novo pathway if there is evidence of the safety and effectiveness of the device and there is not a previously legally marketed predicate device1. When determining if your device can go through the De Novo process there are two pathways available to determine the device classification.
There are three types of 510K, Premarket Notifications, which can be submitted to the Food and Drug Administration (FDA) traditional, abbreviated, and special. Abbreviated and Special 510K submissions can be utilized when the submissions meet the certain factors presented by the FDA. When submitting an abbreviated 510K the submission must include the elements that are identified in 21CFR 807.87 for the information required in a premarket notification submission.
Many marketed products are classified as medical devices and you would not even know it. Medical devices range from latex gloves and tongue depressors to respirators and heart valves. To determine if the product is considered a medical device by the Food and Drug Administration (FDA) you will need to analyze if your product meets the definition of a medical device per the Food, Drug, and Cosmetic Act1.
There are many ways to sterilize medical devices before use in the industry. The common methods utilized are steam, radiation, dry heat, ethylene oxide, and vaporized hydrogen peroxide. There are two methods of sterilization for medical devices recognized by the Food and Drug Administration (FDA), established and novel.
Many companies do not understand the benefits of having a structured Quality Management System (QMS). A QMS is a system that documents procedures, processes, and responsibilities to achieve quality objectives and policies1. Quality management systems can be utilized in many industries especially the pharmaceutical and medical device industries, to provide structure for all processes at a facility.
A Fishbone diagram is a risk management tool used to visualize cause and effect to analyze the root cause of a product or quality problem in the pharmaceutical and medical device industry. The fishbone diagram is additionally known as the Ishikawa diagram, created by Kaoru Ishikawa in the 1940s.
A Corrective and Preventative Action (CAPA) is a tool utilized in order to address an issue or a potential issue with a product or process. According to the FDA “The purpose of the corrective and preventive action subsystem is to collect information,...
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