Kymanox is Hiring!

–To see the new available positions visit our Careers Page!– Kymanox Expanding, Hiring For Several New Positions New Full-Time, Permanent Jobs Have Been Created at Kymanox Research Triangle Park, North Carolina, United States  |  Thursday, 13 July 2017  |  Kymanox management has approved seven new positions to usher in next growth spurt. Kymanox is working… Read More

Device Design Dossier, History and Technical Files

-Keeping Up with Device Record Requirements- 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… Read More

GMP Facility Design

-Manufacturing GMP Facility Design- 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… Read More

Mechanical Integrity

-Risk Based Inspection- Pharmaceutical and biotech production facilities, and the processing equipment are aging, with many systems aging beyond 20 years. Manufacturers are now beginning to experience problems associated with aging, and are having to develop strategies to respond to the approaching equipment end of lifetime. Traditionally, manual inspections are used to detect potential issues… Read More

Process Development

-Manufacturing Process Development- One of the most important steps in bringing any pharmaceutical product to market is designing and developing a robust manufacturing process that can reliably create a product that meets customer needs. Significant challenges can occur when scaling a product from the lab bench to commercial scale manufacturing and a poorly designed manufacturing… Read More

Risk Evaluation and Mitigation Strategies (REMS)

-Risk Evaluation and Mitigation Strategies (REMS)- In 2007, a new law was enacted that provided the FDA many new authorities and responsibilities to enhance drug safety. The new law is termed the Food and Drug Administration Amendments Act- sometimes referred to as “FDAAA”- and one of its provisions gave FDA the authority to require a… Read More

Quality by Design

-Quality by Design- 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… Read More

Quality Management Systems

-Quality Management System (QMS)- A quality management system (QMS) is a set of policies, processes and procedures required for planning and execution (production/development/service) in the core business area of an organization and is focused on achieving the organization’s quality policy and quality objectives.  Implementing and establishing a QMS affects every aspect of an organization’s performance.… Read More

Materials Management

Materials Management Of all the subsystems of a Pharmaceutical Quality System, the Materials Management subsystem may require the most cross-functional collaboration and teamwork. For example, the Materials Management subsystem does not simply apply to warehouse personnel. This subsystem includes the warehouse personnel who receive, store and handle components and raw materials and distribute final products,… Read More

Data Integrity

Data Integrity Data integrity within a CGMP environment is defined as “the assurance that data records are accurate, completed, intact, and maintained within their original context, including their relationship to other data records”. This requirement applies to paper, electronic, and hybrids of both electronic and paper records to ensure that data is reliable, true and… Read More