Monday, September 17, 2012

Topic14: SOPs in MA

Now for a topic no one wants to talk about but everyone should become more familiar with – Standard Operating Procedures.  The hard truth of today’s world is that SOPs are no longer optional for MA.  In fact, SOPs are critical for success in today’s global MA.  In this post, I will discuss SOPs in general as well as share some do’s and don’ts for developing effective MA SOPs.

Our brethren in Clinical Development have been living in a world of SOPs for much longer than MA because their work was more explicitly regulated.  When you are regularly audited by agencies looking for an excuse to delay the marketing of your next blockbuster, you are highly motivated to have whatever documentation they are looking for.  And, in CD, that means SOPs that clearly demonstrate that all clinical trials are conducted following GCP and other related standards.

In MA we used to be less concerned about regulation enforcement, but those days are over.  So, what is the state of MA’s SOPs?  If your environment is like those in my experience, the answer is a mixed bag.  Many organizations have some good SOPs but few organizations would claim their SOPs are simultaneously:

  1. Complete

  2. Accurate

  3. Trained and understood by the relevant staff

  4. Consistently updated

Most MA leaders will tell you it’s important and on the organizational To Do list but it rarely seems to rise up to the top of that list and almost nothing below number 3 on that list can get addressed in any given year.

Yet SOPs represent one of the very best defenses any organization has to arguments that it is operating contra to regulations.  By having clearly defined processes that are compliant, a training program to show that people learned and understood those processes and a program to ensure that those SOPs remain updated, the organization has a very strong argument in its favor, even if a single actor is caught performing incorrectly, the argument can be made that it is a single bad actor not an institutional problem.

But SOPs are not just defensive in nature.  When well done, SOPs represent an opportunity to capture best practice and apply that best practice on a global level.  Every country, every region does not need to re-invent the wheel.  What we do in MA is standard enough that we should be able to build a single optimized approach that we can apply on a global basis.

When building SOPs there are some definite Do’s and Don’ts.


  • Leverage major disruptive changes to implement or enhance SOPs

    • SOPs are a major effort and often difficult to justify on their own (see To Do comment above)

    • Instead, leverage a new system implementation, new regulatory regime or other major change that seems to hit every year or two as the vehicle for investing in SOPs

  • Be inclusive

    • Ensure to involve every function and every region that is affected by the SOPs, even those that are outside MA

    • Make sure the SOPs remain valuable throughout the globe if possible

  • Develop MA-specific SOP templates and development processes

    • Trying to take the CD SOP development templates and processes can result in over engineered MA SOPs

    • MA SOPs don’t need to be as detailed or structured as CD SOPs because the goals are different in terms of regulatory support – CD SOPs need to comply with GCP at a minimum which drives a certain level of depth that is not necessarily required in MA

  • Remember the Training

    • Training is the link between SOP development and real world value, yet many organizations fall down on this important step

    • SOP development efforts seem to lose steam after the creation effort and often result in training programs that fail to ensure that everyone who should learn does learn


  • Pave the Cow Path

    • Don’t just document the current process (cow path), instead take the opportunity of SOP development to do some process improvement work capturing best practices and defining new approaches

    • This may take a bit longer but the results are significantly more valuable

  • Get Overly Complex

    • SOPs are guidelines not computer programs – the more detail the LESS valuable the SOPs can become as more and more real world situations don’t fit into the very specific processes

  • Forget Certification

    • Its great to train, but in the future someone will question whether the training was effective – without some type of certification to prove understanding on the part of the trainees this is very difficult to prove

    • Certification does not, and should not, be onerous – just enough to prove that the key points are understood

SOPs in MA – not a topic anyone gets excited about tackling.  Yet, SOPs are going to grow increasingly important as the regulatory burden on MA grows.

What is your experience with MA SOPs?  Leave a comment and let me know!

1 comment:

  1. Indeed Gary we now have many more MA-specific SOPs or Local Working Instructions to clearly delineate key activities that MA personnel do. Many of these relate to increased scrutiny of MA activities and so are both protective of the company and for the first time clearly outline how to do many of these important MA acitvities.


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