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.
Quality Through Automation
Whether looking to update an existing process or implement something brand new, process design is a critical aspect to...
Accurate and precise measurements are vital in the pharmaceutical, medical device, and other FDA regulated industries....
The environmental monitoring program in sterile drug manufacturing
Many controls are well-designed and put in place to help drive and maintain the quality of the sterile drugs produced by aseptic processing. Perhaps one of the most important controls is the environmental monitoring (EM) program. The main purpose of the program is to document the state of control of the facility and aseptic process; however, it does not determine the quality of the finished drug product.
All right, you have just gotten all of your paperwork together, submitted the right forms to the right people, set up your factory, hired and trained your staff; now it’s time to make the medical devices. The regulatory nonsense is over and done, right?
FDA Adverse Event Reporting
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.
De Novo Classification
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.
Abbreviated 510k submission
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.
Is your product a medical device?
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.
Intended Use Validation
Medical Device Manufacturers in the United States have to comply with intended use validation (IUV) requirements....
Quality Management Systems that CLIC™
While a Quality Management System (QMS) is a necessary and foundational element of any life-science...
Is Electronic-IFU an Option?
Changes in technology call for changes in the ways we use that technology. This means that the instructions for use...