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

SAP / ERP – FDA Compliance

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… 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

Gap and Risk Assessments

Mission-Critical Technical and Compliance Assessments Gap and risk assessments are commonly used to help improve aspects of your organization, to prepare for an external audit, or to ensure your drug development program is on track. The Kymanox Assessment Team can help you identify the gap between your current state and the desired future state, along with… Read More

Process Equipment Procurement

Process Equipment Procurement Whether you are building a new facility or making upgrades, procuring the proper process equipment can be tricky. Small or large, all pieces of process equipment require the same high level of process knowledge, functional suitability, and the need to be engineered to fit the process, product, and facility requirements. Given that… Read More