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 design an integral part of development. As a result, …
Current Good Manufacturing Practices (CGMPs) enforced by the FDA require that all manufacturing processes be validated. Validation ensures that controlling the inputs (i.e. parameters) within an acceptable range will consistently produce outputs (i.e. products) of acceptable quality. The current FDA view of CGMPs emphasizes a risk and science-based approach to biopharmaceutical manufacturing. As a result, Process Validation is viewed as …
Is your process not running consistently? Are some pieces of equipment requiring too much attention from maintenance and engineering? We all know how frustrating this can be – sometimes it feels like you’re running in circles. You also understand the importance of a structured approach to analysis, troubleshooting, and problem solving. Kymanox utilizes Ideal Knowledge Transfer (IKT) and Formal Problem …
In the pharma industry, manufacturing operations are routinely in the pursuit of perfection. There have been a number of initiatives to foster this pursuit; Six Sigma, Kaizen, and many other efforts. All of them at their core are for the search for one thing: Process Optimization. They are looking for the core elements that are needed to efficiently and effectively …
Are you thinking of designing, planning, installing, modifying, or validating a cleanroom? Kymanox can help you with that! We are experts in cleanroom engineering and can assist you with your cleanroom no matter if you are in the design phase, needing construction support, or validation. Our reputation has been built on quality work, prompt reporting, and engineering excellence. We work …
One of the most important elements of a Quality Management System (QMS) is the Corrective and Preventive Action (CAPA) system. The purpose of the CAPA system is to identify, investigate, and correct or prevent product and quality nonconformities or other undesirable situations. Corrective action is an action taken to eliminate the cause(s) of a detected nonconformity or other undesirable situation. …