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. …

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 …

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 …

FAT / SAT Support

Investing in equipment should never have to be a risk. Testing equipment and reviewing documentation for traceability purposes does a great deal towards lowering the risk of your investment. Accepting the equipment only after completing a Factory Acceptance Test (FAT) is industry standard, but the process can be overwhelming. A few ways to make an FAT run smoothly include: Commissioning: …

Quality Risk Management

Quality Risk management (QRM) is a systematic process for the assessment, control, communication, and review of risks to quality of the drug product across the product lifecycle. The approach to managing risk is established via an evaluation of risk to quality. The evaluation is based on scientific knowledge and ultimately linked to the protection of the patient. The level of …

Corrective and Preventive Action (CAPA)

One of the most important elements of a Quality Management System (QMS) is the Corrective and Preventive Action (CAPA) system. The purpose of the CAPA system is to identify, investigate, and correct or prevent product and quality nonconformities or other undesirable situations. Corrective action is an action taken to eliminate the cause(s) of a detected nonconformity or other undesirable situation. …