Aging Facilities and Quality Risk Management

Because the biopharmaceutical pipeline is becoming more complex, with new molecules emerging that are much more challenging to manufacture, the industry is now re-thinking the traditional one product-one facility approach to manufacturing. In an attempt to create much more flexible manufacturing facilities that can be adapted for multiple products concurrently, as well as to market demand. Companies are creating novel facility designs for both newly built facilities, as well as retrofit designs for aging/legacy facilities.

Dr. Christopher Smalley, Director, Global Technical Operations at Merck & Co. provides exclusive insights into a couple key issues – Aging Facilities and Quality Risk Management – issues that he believes to be both a current challenge and a key trend in the bioprocessing industry today.

The following is an excerpt from our conversation with Dr. Smalley – There are several serious issues facing the industry today, and one of those relates to what is sometimes referred to as ‘Aging Facilities.’ Rather than try to describe what an ‘Aging Facility’ is, because there is a great deal of confusion surrounding the definition, let me instead describe how it happens. A facility was build some time ago. At the time, it was considered appropriate for cGMPs, passing inspections and making quality product. Over time, for a variety of reasons, one of which might be that the facility is being operated full out to meet either clinical or market demands and there is no opportunity for downtime without risking drug shortages. Another might be the facility is making product with a very small profit margin and there is little capital available for investment in new equipment or renovations. There are many other reasons, but the result is that the facility is wearing out and a coat of paint on the walls or an oil change in the equipment is not going to do the job anymore. So a time comes when a choice needs to be made. But there might be a myriad of choices – do I continue operating the ‘Aging Facility’ while I build a greenfield facility to replace it? Do I replace the utilities or process equipment? Do I do a complete shutdown, or a rolling shutdown? Should I use the opportunity to revise the personnel and product flow in the facility?

This brings us to another challenge to the industry today, the proper use of Quality Risk Management. Many companies may believe they are using QRM, but they might not be using it effectively. Other companies may not be using QRM, or may in fact be misusing it. There are two keys to QRM that need to be considered, first is to have the right people in the room to determine what the risks truly are – cross contamination, yield, micro contamination, equipment efficiencies, interminal ‘holds’ due to questions about the batches? Second is to obtain the objective information relative to those risks – companies are sitting on a wealth of data and not managing it properly to obtain the information needed to make good decisions. And it is not always a matter of having the latest and best IT system.

Ultimately we will blaze a trail to lead us away from ‘Aging Facilities’ back to efficient and effective cGMP compliant facilities.


Want to hear more from Dr. Christopher Smalley? He will be speaking at the upcoming BioProcess International Conference & Exhibition in Boston, MA.  Click here to find out more.

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