The Parenteral Drug Association (PDA) has published a document addressing the challenges of aging facilities – and strategies for modernization.
To learn more about the initiative, Outsourcing-Pharma.com caught up with Maik W. Jornitz, president and CEO of G-Con Manufacturing Inc. and co-chair of the PDA Aging Facilities Task Force.
Why was the document created and how was it developed?
PDA via its membership realized that aging facilities become a major concern, especially being a major contributor to drug shortage or stock-out situations. Initial discussion showed a variety of opinions and approaches how to define and to approach aging facilities. It was realized that we require creating consensus and support to be able to either avoid incidence due to aging facilities and to determine potential preventative measurements.
To do so the science advisory board agreed to form a task force to address aging facilities. The task force realized very soon that the task requires to broken up in three sub-section, which were facilities, processes and analytics.
Once done we run a survey to gain further information about aging facilities and run a workshop to trigger discussions on how aging can be remediated. These two activities, information collection and discussions within a very knowledgeable team of experts in the task force formed the points to consider paper.
What are some of the main impediments to modernization?
The two common statements we received repeatedly were the difficulty to gain approval for investments to modernize the facility and the lengthy regulatory post approval process.
Both are interconnected, as global post approval can take up to 5 years, which also means the possible need to run multiple process scenarios parallel and the increase of financial risks impacting the business. Therefore, the approval process for investments and processes or facility changes may be delayed or not even considered.
In instances, one saw that the facility was used till the end of the product lifecycle without any initiative of modernization, which may enhance financial and quality risks, but certainly equipment or process break-down.
The approach to prevent investment hesitancy has to be to visualize the cost of bad quality versus investments into good quality. The lengthy post approval change problem is now being focused on by another PDA Task Force.
How does modernization benefit manufacturers?
Again, the cost of bad quality is much higher than the cost of producing good quality. Since cost of goods sold is a major focus within our industry, costs require to be reduced and best would be to do so with robust and reliably running facilities and processes.
Modernization avoids break-down or deviations, it will run the system efficiently and reliably, a key element not just for capacity utilization purposes, but also to keep the manufacturer out of the media by annulling recalls or drug shortages.
What are some of the key ways companies can slow the aging process at facilities?
The key activity is rigid and thorough maintenance schedules, which either remedy process or facility weaknesses or are able to forecast when equipment requires to be exchanged.
Often break-down happens when systems run constantly without the proper time investments for maintenance. It though is essential to be able to verify the systems are running as specified, but also to see when such system could break-down.
Maintenance should not be restricted to the fixing the systems, but also checking whether the system becomes obsolete or spare parts are still available. Often there is a surprise factor when parts of machinery are not any longer available and an alternative requires to be evaluated with haste.
Supply agreements can remedy such situation to assure the supplier informs the end-user in advance that a system requires upgrading as parts are not any longer available.
The maintenance and systems review requires much more proactivity than reactivity, as the latter can cause an implementation of a compromise and not the robust solution needed.
How has the regulatory landscape changed and how will manufacturers need to keep pace?
It probably is not necessarily the regulatory landscape change, but the technology changes, which make it difficult for the industry to keep pace with. There are more and more innovative technologies launched, which will enhance the efficiencies and the safety of manufacturing processes and facilities.
However, due to the regulatory burdens of post approval change and the time consumption of this process, the industry hesitates to implement new technologies.
The major change needed is a harmonized global regulatory post approval change process, where one regulatory agencies recognizes the approval of a change from another agency. This would cut down the tremendous time needs to have a change approved and reduce the technology implementation aversion level.