KENX INSIGHT

Medical Product Excursions

Stability excursions are unintended lapses in the control parameters (such as temperature, relative humidity, and light) which are designed to preserve a product at experimental, manufacturing, shipping, and patient environment conditions. Significant excursions bring into doubt the validity of data generated in stability studies and the integrity of product during manufacturing and distribution…

Grouping equipment for cleaning validation is a common practice for reducing execution, resources, and production downtime.  Though regulatory [1] [2] and industry guidelines [3] support the practice and provide guidance, there is a clear requirement for scientific justification.

As capital projects and technology transfers wrap up and facilities grow nearer to startup, site leaders and team members may be filled with a sense of excitement or dread depending on their confidence in the site’s operational readiness…

This is a nontraditional view for understanding and navigating high-stakes change environments, such as FDA Warning Letters….

Emerging technologies are quickly playing a greater role in how the Pharmaceutical and Life Sciences Industry collects,
stores and interprets its data…

The Food and Drug Administration (FDA) has recently proposed dramatic changes to the current Computerized System  Validation (CSV) approach that is being used by most companies in the Life Science Industry...

Software as a Service (SaaS) is a cloud computing delivery model that promises various benefits, but also comes with unique risks. The life science sector has a very slow cloud adoption rate…

Successful product validation depends on operational readiness: facility and equipment, development knowledge with thorough analytical and process design documentation, trained cross functional staff at the manufacturing site and a robust formulation and process…

Despite having robust design and environmental monitoring, cleanrooms are at risk for several sources of contamination…

In 2018, the FDA released “Data Integrity and Compliance with Drug cGMP, Questions and Answers, Guidance for Industry.” Between 2015 and 2019, the number of 483 observations written globally increased by more than 10%. The increase indicates that…