In order to market a medical device in the United States or the European Union (as well as other regions of the world), a manufacturer must comply with the regulatory body requirements concerning the files and records necessary to prove that a medical device was designed and developed in a manner to maximize its safety and effectiveness while minimizing its …
Kymanox has been designing GMP facilities since its inception. We provide upfront facility design layouts and partner with other engineering firms to produce facility permit drawings. In addition, we offer assistance with facility location selection. Kymanox have produced the conceptual designs for a wide range of GMP manufacturing buildings: Pharmaceutical (Solid and Liquid Dosage); sterile and non-sterile fill; label and …
Quality by Design (QbD) is a structured approach to process development that emphasizes science and risk management principles. Applying QbD allows companies to develop manufacturing processes that are safer and more compliant with CGMP regulations. The fundamentals of the Quality by Design approach are: Develop detailed process and product understanding from historical knowledge and product specific experimental data. Use rationally …
A specification is defined as a list of tests, references to analytical procedures, and appropriate acceptance criteria that are numerical limits, ranges, or other criteria for the tests described. It establishes the set of criteria to which a raw material, drug substance or drug product should conform to be considered acceptable for its intended use. Specifications are chosen to confirm …
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, …
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, …
Greenfield Process Engineering, C&Q and Compliance Support Kymanox consists of a diverse team with a broad range of experience and expertise that allows us to support facility start-up projects from conception to completion. We work with our clients to provide tailored support that meets their specific needs as well as applicable regulatory requirements. We have a diverse team with engineering, …