<span class="archive__title-prefix>Posts Categorized:</span> Blog

In Peter Baker’s first presentation with Redica Systems on quality intelligence, he spells out how he sees pharma companies actually reaching the goal of modern quality intelligence, based on FDA guidance, 483s, and other sources—a long road trip with several stops and no shortcuts.  The former FDA investigator and current President of Live Oak Quality […]

Early-phase cell and gene therapy (CGT) product development focuses primarily on product safety issues. However, it is also critical to demonstrate the firm’s capability to consistently and reproducibly manufacture its investigational product. At the ISPE Annual Meeting held in Orlando, Florida, in early November 2022, Center for Biologics Evaluation and Research (CBER) Office of Tissues […]

When an FDA-regulated company interacts with the FDA, there are a few things on the line, such as consumer and patient well-being, millions or even billions of dollars, and your company’s reputation. Advice on the legal implications and how to be prepared can help you and your team through inspections with the FDA and other […]

Redica Responds is an article series where we take common/unique questions from customers and industry events and answer them with our data. What are the top 483 observations involving laboratories over the past five years (2018-2022)? The laboratory is a critical element of a human drug GMP site. Laboratory roles include testing raw materials, conducting […]

Cell and gene therapy (CGT) is an emerging and promising field of medicine that offers cures for rare and debilitating diseases, though often at exorbitant costs. The science supporting CGT is complex, and serious side effects are possible. The complexity and variability of these technologies, their novelty, the assays required, and the excitement of the […]

Is it True that Health Regulatory Authorities Do Not Have Access to Internal Audit Reports? Yes and no. It is true that FDA has a policy not to review internal pharma company audit reports during facility inspections, although there are circumstances where the reports must be provided. In the case of FDA, investigators can ask […]

This article covers additional questions submitted following the webinar, “Data Integrity and Quality Culture – Enabling far more than “just” compliance.” presented by Ulrich Köllisch, Manager and Subject Matter Expert on Data Integrity, at GxP-CC on November 10, 2022.  In the webinar, Köllisch shares insights into the latest discussions on merging data integrity and quality […]

Which GMP quality system was most often linked to FDA drug recalls since 2012?  Redica’s Jerry Chapman asked the audience that question at the February Pharma Hot Topics Conference in San Diego during his presentation, “A Deep Dive Into Industry-Wide Recall Data: Leveraging an Expert Ontology and AI to Uncover Patterns and Insights.” A senior […]

As the life sciences industry moves towards a more automated and data-centric world, we need to implement best practices in data management. One area of focus is quality intelligence. Staying current on your QMS needs, inspectional information, and analyzing the data are essential skill sets that your team needs.  Download our recent webinar, Quality Intelligence: […]

“Data as an asset opens the way for a data-driven future,” proclaims Ulrich Köllisch.  In that future, life sciences manufacturers regularly rely on data-intensive, validated tools: natural language processing (NLP) for categorizing and parsing long lists of deviations, for example, real-time multivariate process control guided toward a “golden batch”; or even more exotic data applications. […]