The Journal of GXP Compliance
Vol. 24, Issue 4, Jul 2020

Umit Kartoglu, Kevin O'Donnell and James Vesper
The COVID-19 pandemic requires robust risk control strategies; these should be multi-layered, science-based and subjected to effectiveness checks and formal reviews, to identify any unintended consequences. They should be supported by communications informed by an understanding of biases and risk perception.
Tim Sandle
The concept of lean production or lean manufacturing was probably developed by the Japanese car manufacturer Toyota (Toyota were the first to publish case studies). The lean approach is founded on the concept of continuous and incremental improvements on product and process while eliminating redundant activities. The concept can be applied to a...
Cliff Campbell
This paper introduces and discusses the concept of intrinsic compliance as an enabler of accelerated and economical qualification/validation. It utilises rudimentary set theory in support of this objective. It also defines a number of technical terms, including process parts, facility counterparts, composite objects, relational data, risk flags,...
Ivan Soto
The investigation of deviations is a critical component of the Quality Management System. Investigation of deviations is intended to determine the root cause of a deviation event. During the product lifecycle at a GMP manufacturing facility, many deviation events are encountered related to issues such as neglecting to follow procedures, inadequate...
Karen R. Zimm and Renee King-Alliego
Regulatory Affairs has an alphabet, acronyms and language seemingly all its own. It can be daunting to colleagues and professionals working in the industry who are not in Regulatory Affairs (RA), but working with and alongside RA. There are many terms employed when discussing anything in RA and it can be helpful to lay them out in a way that gives...
Ratul Saha
To develop an effective contamination control strategy for a viral vector manufacturing facility, two points are important to consider from microbial control perspective: 1. Contamination of the manufactured product (i.e. cell bank or viral vector) from exogenous microbial sources and 2. Cross-contamination between product types (viral vectors)....
Kevin O’Donnell, Deidre Tobin, Stephanie Butler, Ghada Haddad, and Donal Kelleher
Formality in Quality Risk Management (QRM) is an interesting concept. What makes a QRM activity ‘formal’ and what makes one ‘informal’? A simplistic viewpoint might be that formal is when a QRM tool is used to manage risks, and informal is when no such tool is used. But is it that simple? And are there different degrees of formality in QRM - is...
Paul L. Pluta
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Stacey L. Bruzzese
Pharma managers in the US and Europe have expressed that they simply do not have time to talk about management. They are too busy fighting fires in their plants, approving protocols, releasing batches, doing investigations, fixing problems, responding to emergencies, and so on - doing the activities essential to their respective site businesses...
Daniel O'Regan and Cliff Campbell
This paper highlights the practical benefits to the industry, of adopting the concept of the Spectrum of Importance (SOFI) an alternate approach to understanding and prioritizing process parameters. This approach represents a move away from the current binary critical/non-critical one that is widely used by many companies today; instead, it...
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