503B Outsourcing Facilities

Kymanox Sterile Compounding Expertise Summary For more than a decade, Kymanox has been a recognized leader in the areas of CGMP manufacturing, process engineering, quality assurance, regulatory compliance, validation, and quality control.  Kymanox understands that pharmacies play a major role in the US healthcare system and this industry is undergoing rapid change coupled with difficult economic and regulatory environments.  Ultimately, …

Kymanox is Hiring!

–To see the new available positions visit our Careers Page!– 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 hard to help clients bring modern medicine to patients in need. To …

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 and Liquid Dosage); sterile and non-sterile fill; label and …

Mechanical Integrity

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 inside processing equipment, particularly corrosion, rouging, or scratches. …

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 process can compound these issues. These problems should …

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 Risk Evaluation and Mitigation Strategy (REMS) from manufacturers to ensure that …

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 knowledge and product specific experimental data. Use rationally …

Quality Management Systems

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. Although any QMS should be created to address an …

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, but it also includes the purchasers who …

Item Specifications

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 …

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 transfer, real risk management, data …