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 …

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 accurate. The FDA and other regulatory agencies …

Kymanox Celebrates Diversity at Triangle Curling Club

On a regular basis, Kymanox honors its diverse employee base by gathering together and celebrating one of its team member’s heritage. As there are two Canadians on the team, Triangle Curling Club was the chosen venue. Along with this challenging team-building activity, those in attendance got to enjoy a delectable Canadian dessert, butter tarts!

Kymanox partners with Shire at CPhI North American Conference

The inaugural CPhI North American conference in Philadelphia, PA proved to be a great event for pharmaceutical industry professionals. Kymanox’s CEO Stephen M. Perry and Shire’s Head of Global Drug Product Manufacturing Science & Technology Stelios Tsinontides, PhD presented on Proven Practices to Speed Up Commercial Tech Transfers & Achieve RFT.

Gap and Risk 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 the necessary tasks needed to close all gaps. Kymanox can …

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 this equipment runs the high risk of being …