Microbial contamination is of great concern in pharmaceutical and biotech manufacturing. Many organizations struggle with determining the root cause of contamination when it occurs, and identifying effective safeguards to prevent future contaminations. This article will introduce a new model for understanding microbial contamination in biopharmaceutical and sterile products and processes. The āContamination Triangleā identifies the three factors necessary for microbial ingress into a sterile (or pure) system. The use of this model will provide guidance for contamination investigations, clarify the explanation of the contributing root causes in Non-Conformances, and assist in identifying risks and risk mitigation measures as part of a Failure Modes and Effects Analysis (FMEA) or other risk assessment methodā¦
Tag: <span>fmea</span>
Implementation of āreal-timeā analytics (RTA) in processes for biologics is challenging from a technological and timeline perspective. Therefore, there need to be significant drivers from both a regulatory (quality) and a monetary standpoint to justify investment. Understanding how regulatory agencies define real-time analytics and the expectations for implementations (how and when) is a key component to rational decision-making, and dovetailing process improvement and facility design is important in the planning and development processā¦
Biologics Production Cell & Gene Therapy Cell Lines Mammalian Cell Culture Manufacturing Regulatory Viral Reference Materials Viral Vectors
at-line analytics biolgics design space biologics cpp critical process parameters design-of-experiments doe fda guidance fmea in-line analytics ind investigational new drug mabs monoclonal antibodies on-line analytics pat process analytical technology real-time analytics regulatory considerations rta
An interesting situation occurred ten years ago in an industry where quality had been the critical factor in management decision-making. Quality was abruptly bumped to second place behind pricing, which started a global rush to find lower-cost suppliers and eventually resulted in massive outsourcing. During this evolution, the importance of quality systems for the pharmaceutical and biopharmaceutical community was recognized by regulatory agencies that began establishing risk management standards.