Is your product a combination product? Combination products are defined in 21 CFR 3.2(e) and more products than ever now fall into this category but many manufacturers are unaware of that fact nine types of combination products. The FDA identifies.Take a look at the table below to see if your …
by Faith Fraley, Director, CQV Engineering at Kymanox Every pharmaceutical manufacturing facility requires a controlled manufacturing environment. Temperature, humidity, and pressure are crucial to products and processes. Deviations can be disastrous, but environmental controls mean nothing if they aren’t properly qualified and validated. A programming issue with humidity controls could …
by Brian Freymann, Director, Enterprise Solutions The core issue that drives compliant solutions is that drug, medical device, and instrumentation companies are monitored closely by the FDA/EMA. The regulatory requirements are designed for the purpose of managing all data that has an impact on patient safety. Both the FDA’s Title …
For more than 25 years, the U.S. FDA and PDA have collaborated on the PDA/FDA Joint Regulatory conference. Participants have the opportunity to engage directly with FDA representatives and hear updates on current efforts affecting the development of global regulatory strategies. Industry experts present case studies illustrating how they use global …
QUALITY BY DESIGN (QBD) & PATIENT CENTRICITY Our overall approach to providing solutions is based upon the principles of Quality by Design (QbD) and patient centricity. In addition to the standard ISO and ICH methodologies, we leverage practical life sciences experience, sincere advocacy for patient impact, expert planning, and sound engineering. We utilize rapid knowledge transfer, real …
Developing a new medical device from concept to market can be a complex process. Design controls are an interrelated set of practices and procedures that are incorporated into the design and development process (i.e., a system of checks and balances) for a medical device. Design controls make systematic assessment of …
The Federal Food, Drug, and Cosmetic Act (FDCA), signed into law in 1938, gives the FDA the authority to regulate the sale of food, drugs, and cosmetics. The regulations that guide the enforcement of the FDCA are given in Title 21 of the Code of Federal Regulation (21 CFR). In …
In 1988, Cholestyramine Resin USP finished drug product (a cholesterol medication) was recalled due to cross-contamination with low levels of an agricultural pesticide. The contamination was a result of a lack of validated cleaning procedures and inadequate control of recovered solvent drums. This recall reinforced the need for validated cleaning …
Practical Hands-On Experience Kymanox has a diverse body of work, practice, and professional experience – exclusively focused on the life sciences. We understand your business in a way that translates into collaborative, cost-effective solutions. We provide: • Clinical Quality Management System Development and Optimization • Clinical Compliance Gap Assessments • …
