Blog
March 18, 2024 || Kevin Hawkins
This is the first installment of a three-part series exploring the transformative power of Virtual Twins when applied to an asset induction effort for facility maintenance. The information in this series is based on the use of Virtual Twin technology for a biomanufacturing site, but the same principles could be…
February 23, 2024 || Mark Burlingham
Facilities Management is a critical aspect of maintaining a safe and efficient workplace. It involves a wide range of tasks, from maintaining the physical infrastructure to managing resources and ensuring a comfortable environment for employees. Below are five key areas where organizations commonly have room to improve their Facilities Management…
February 12, 2024 || Brian Stephens
After several years of conversation with drug manufacturers and consultants about the state of computer system validation, the FDA issued a draft of the Computer Software Assurance guidance in September 2022. Since that time, I have used this guidance to reduce the effort and cost required to complete two large…
February 9, 2024 || Emily Purchase
On January 26, 2024, the Food and Drug Administration (FDA) provided notification of a revised draft guidance on Remote Regulatory Assessments (RRAs). The FDA has updated its guidance on remote regulatory assessments (RRAs), emphasizing that they differ from inspections and outlining new powers granted by a recent spending bill. The…
February 9, 2024 || Joe Leuser
How does your organization determine calibration test points, tolerances, and frequency? A simple rule of thumb to calibrate instruments at 10, 50, and 90% of full-scale range and use a tolerance of 1.5 or 2 times the manufacturers’ tolerance. Many companies standardize frequencies to calibrate all critical instruments every six…
January 15, 2024 || Martina McDonagh
Drug shortages in the pharmaceutical industry is a significant concern that has far-reaching consequences for the industry, the regulators, the healthcare system, and ultimately the patients. These shortages can be for a variety of factors including manufacturing and quality issues. To this end the FDA embarked on the Quality Management…
January 15, 2024 || Robert Ossig
During a pharmaceutical technology transfer (TT) project, the Readiness Stage plays a pivotal role by establishing the groundwork for a successful transition. This phase involves meticulous planning, coordination, and execution of key activities across various functions, each contributing to the readiness of the Receiving Unit (RU) for Process Performance Qualification…
December 27, 2023 || Connie Leech
The Office of Regulatory Affairs (ORA) at the U.S. Food and Drug Administration (FDA) is currently buzzing with activity and exciting developments. Here’s a snapshot of what happened in the last 24 months: In June 2023, the FDA updated its new model for the Office of Regulatory Affairs (ORA). This…
December 20, 2023 || Chris Spiak
As advancements in medical science continue to expand the array of available treatments, the demand for pharmaceuticals has surged. This surge has caused an alarming increase in drug shortages. Complex factors, including regulatory hurdles, supply chain disruptions, and unforeseen global events, have converged to create a landscape where the availability…
December 11, 2023 || David Shenberger
The concept of a “dark factory” conjures images of secrecy and clandestine operations, but in the world of biotechnology manufacturing, it represents an innovative approach to production that promises increased efficiency, quality, and safety. A dark factory is an automated facility that minimizes human intervention, and the operations are primarily…
