One of the biggest and most important aspects of quality management is a system to monitor changes and how they impact the product. Change management is an approach for changing processes or products in a way which adheres to regulatory standards by ensuring stability and consistency throughout processes. It applies across all changes within a process and throughout an entire products life cycle.
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.
Since its inception, EMMA International has been dedicated to providing consulting services to help ensure clients' products advance seamlessly from concept to approval. Throughout this time, the company has continued to grow and expand, solidifying its position as a leader in the field. This growth and success are evident in EMMA International's multiple recognitions on the Inc 5000 list, which highlights the fastest-growing private companies in the United States. The company's unwavering commitment to delivering exceptional services and its ability to adapt to an ever-changing industry have been key to its continued growth and recognition.
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.
How does a medical device manufacturer make sure that they prevent garbage from coming into their factory, and therefore lessen the ways that garbage can go out? Supplier controls are a set of useful tools to evaluate potential suppliers for product quality, as well as other important capabilities of suppliers. It’s not just a good idea, it’s the law, according to 21 CFR 820.50.
The European Commission has implemented a proposal to extend the transitional period to certify medical devices under the Medical Devices Regulation (MDR). The proposal allows more time for manufacturers to transition from the previously applicable rules to the new requirements of the Regulation
After over 3 years, the COVID-19 Public Health Emergency (PHE) will end on May 11, 2023, the Biden Administration announced last week.1After 3.5 years of the modified policy to allow for amore efficient path for COVID-19-related medical products to get to market, this begs the question of how it will impact the MedTech world.