Managers of legacy pharmaceutical manufacturing facilities continually struggle against aging infrastructure, improvements in technology, as well as catching up and anticipating the evolution of good manufacturing practices. Among the challenges facing legacy facilities are the burden of outmoded infrastructure, equipment that has reached the end of its useful life and production facilities that have not keep pace with current standards for good manufacturing practices. “Current” is a key word in the legacy facility arena, as noted by the FDA’s “Facts About Current Good Manufacturing Practices (cGMPs)”:
“…the “c” in cGMP stands for “current,” requiring companies to use technologies and systems that are up-to-date in order to comply with the regulations. Systems and equipment that may have been “top-of-the-line” to prevent contamination, mix-ups, and errors 10 or 20 years ago may be less than adequate by today’s standards.”
Figure 1: Graph illustrating the effort needed to stay current with aging infrastructure,
improvements in technology, and the evolution of good manufacturing practices.
What Defines a Legacy Facility?
Legacy facilities are defined as those existing manufacturing facilities that have developed over an extended period of time and, in the process, have accrued incremental changes from their original configuration. One oral solid dose (OSD) facility recently renovated was first constructed in 1962 and then expanded in 1966, 1973 and 1989, more than tripling in size over a 30 year period. This facility is over 50 years old now! Changes were made to create more capacity and space for new product lines, interior spaces and the movement of material and personnel were repeatedly reorganized, new production equipment added. However, due to random placement of production areas and lack of integration into existing flows, the facilities have less than ideal material and personnel flows, increased handling and staging, which results in less efficient operation and can lead to issues with compliance with cGMPs. Sound familiar?
Figure 2: Example of an OSD facility first erected in 1962 that more than tripled in size
over 30 years and is still in use after 60 years.
Is There a Business Case for Maintaining Legacy Facilities?
The short answer is: yes.
While problematic to accommodate new products and technologies, an established facility has many embedded attributes that make it attractive as a vital part of a company’s future.
- Capital investment - “Bricks-and-mortar” construction costs for the building structure, utilities and other infrastructure are all realized and readily available for future contributions. Capital costs for equipment have already been invested and the production operations well established.
- Staff at an existing facility – typically the greatest operational expense of any facility. The employer accrues intangible benefits from their investment in personnel in terms of training, experience and knowledge.
- Established logistical Infrastructure – location of every facility is integral to its operations. Support services, vendors, material suppliers, shipping/ transportation services, have integrated the specifics of a location, including established procedures, into the delivery of their services.
So What Should Be Done?
A master plan presents the opportunity to develop a vision for the future. For a legacy facility, the master plan can establish a direction to reinvent a facility that will remain sustainable, viable, productive, successful, and profitable. The master plan provides the comprehensive evaluation of the strengths and weaknesses of the legacy facility and seeks to identify opportunities within constraints. From the analysis of the legacy facility, the master plan will identify specific improvements that will best implement the goals of streamlining materials flows, personnel circulation, and improving the condition of critical utilities. More about specific contents of a master plan in our next blog.
What Does the “Band-Aid” Approach Do?
It is human nature to look at short time horizons, such as the next quarter or the next year, without taking the time to look at the broader life-cycle of a facility. In the fast paced market place of product delivery, it is often critical to implement new production strategies or new product lines in as short a period as possible to accelerate return on investment. Some common objections to taking the time to develop a master plan for the legacy pharmaceutical manufacturing facility include:
- Corporate Pressures: Site management often states that corporate management doesn’t understand site conditions and is always pushing to have things done faster and sooner with less labor and little disruption to the manufacturing process and production schedules.
- Time: It is sometimes argued that site management is already overburdened with day-to-day operational duties. Taking time to meet with design professionals to evaluate legacy facility operations will take away from core responsibilities.
- Money: It may be claimed that money spent on a master plan is not money wisely spent. This simple accounting often does not include lost time and profit due to inefficiencies that accrue in the legacy facility due to the additive nature of previous alterations
- Flexibility: Some fear that adopting a master plan will in some intangible way restrict or limit the ability to rapidly respond to changes in technology, production equipment, or the implementation of new products.
- Tradition and Convention: The “that’s-the-way-we’ve-always-done-things-around-here” mentality. While this is human nature, such an attitude works counter to the need to sustain successful operations into the future.
Legacy facilities represent a significant investment, and by definition, they have been highly productive and profitable and retain the potential – with careful intervention – to remain so into the future.
There is no doubt that developing a strategy to keep these facilities sustainable in a future is necessary. The master plan can provide recommendations of how to do that. In our next blog we explore major components of the master plan and how it helps to concentrate on a “big picture.”
Is your company currently working on a plan for its legacy facilities? What specific questions do you have about the issues involved? Share your thoughts in the comments section.