ABSTRCT
Over the last decade, as outsourcing has evolved into the rule rather than the exception in the pharmaceutical industry, many
lessons have been gleaned by those involved in the day-to-day business of contracted operations. Experience has shown that
it is imperative to assess and qualify a contract organization to ensure it is capable and compliant, but this practice alone
rarely ensures that contracted operations will go as smoothly as hoped. Just as we have used risk assessment and risk management
techniques in identifying the critical quality parameters of our products and processes, we can likewise use them in our efforts
to identify those factors essential to monitoring and managing outsourced activities. The application of risk assessment principles
to these supporting fundamentals will help us to realize the full benefit of these partnerships, while at the same time ensuring
appropriate and adequate oversight of outsourced activities.
BioConvergence, LLC
|
Between 2001 and 2008, many companies were reporting annual double-digit increases in dollars on outsourced activities. Even
in the current economic climate, as spending is being curbed across the industry in general, the trend toward becoming more
externally vested is still evident. A 2009 industry survey encompassing all categories of pharmaceutical companies reported
that nearly two-thirds of those surveyed expected the amount of outsourcing spending at their company to increase or remain
the same in the coming year.
Experience has shown that it is imperative to assess and qualify a contract organization to ensure it is capable and compliant,
but this practice alone rarely guarantees that contracted operations will go smoothly. These exercises provide valuable information
and assurance concerning a site's or an organization's state of control, but they often have failed to demonstrate any consistent
correlation with successful execution. We should accept initial or re-assessment activities for what they are—a snapshot in
time providing an overview of a site's systems, prefaced with all the caveats and limitations accompanying that understanding.
If assessment and qualification practices cannot secure successful execution, what other practices should an organization
adopt to help ensure that contracted activities meet user group requirements and expectations? There may be a host of technical
causal factors behind outsourcing disaster stories, but, ultimately, most of them can be traced back to a breakdown in systems
or a disregard of certain fundamentals. As with so many other elements within a thriving quality system, risk assessment can
play a critical role, and support the three fundamentals of successful engagement listed below.
1. Clear delineation of roles, responsibilities, and expectations.
2. Providing appropriate oversight of contracted activities.
3. Monitoring performance.
