In facility design, the term “modular design block” is used for “pre-engineered” or “predesigned” solutions. This approach suggests that a new facility design need not be unique but can use and leverage a pre-engineered set of component pieces. The further down the supply chain standardized modules and components reach, the wider the benefits.
The EU's final version of the GMP Annex 1 is now published, and it's time to take action. This article shares a road map to navigate what is new and different, how to document your "known unknowns," and more. Quality risk management and a contamination control strategy will be key.
You've finally received the grant you need to make your biopharma business a reality. The tough part is over, right? Not exactly. If you mismanage your funds, you could end up on the government’s naughty list.
Two of the most commonly used terms used in pharmaceutical cleaning validation are the Maximum Allowable Carryover (MAC or MACO) and the Maximum Safe Carryover (MSC). This article provides the historical development of both terms and why we should replace the MAC/MACO with the MSC.
The last five years have been disruptive regardless of sector, yet biotech managed to weather the storm. This article looks at the past five years in the industry from a macro view and shares what biotech executives should consider in the months ahead.
This article is the first in a five-part series providing contemporary, practical, and useful examples of data integrity within each of the five traditional principles of ALCOA. This article centers on A: Attributable.
The manufacturing lag in developing innovative biological drug therapeutics has created a bottleneck, so the industry needs better streamlining. That's where establishing a strategic partnership with the right CDMO partner can step in to accelerate your development and manufacturing timeline.
At a recent Evaluating BioPharma virtual event, moderator John Bonham-Carter asked Chris Hwang, chief technology officer at Transcenta Holding Ltd., about Chris’ journey and experiences with continuous bioprocessing thus far in his career.
Part 1 of this two-part series began to compare the environmental impact of biopharma continuous manufacturing with batch manufacturing. In this article, the author considers process efficiency, single-use technology, and facilities requirements.
The FDA will issue a Form 483 for noncompliance in the software validation GxP environment, mostly due to data integrity failures, inadequate written procedures, deficiencies in investigations, and substandard laboratory controls.