Breaking Bad: When It Comes to
Technology Transfer, Old Habits
You know you should be using the FDA 2011 Process Validation
(PV) Guidance, so why aren’t you?
By Walt Murray, CEO of ARC Experts and a MasterControl Quality & Compliance Consulting Partner
Bad habits interrupt our lives and prevent us from accomplishing our goals. Some, like smoking, jeopardize our physical health. Others, like self-criticism, take a heavy
mental toll. All bad habits waste time and energy.
So, why do we cling to them?
Change is hard, uncomfortable even. Habits
are so ingrained in our brain, we perform them
automatically, even when we stop benefiting
The same holds true for detrimental work
habits. You know you shouldn’t check your email
every five minutes or gossip at the water cooler,
but you do. While some bad habits can zap your
productivity, in high-risk environments, such as
pharmaceutical manufacturing, they can be deadly.
Yet time and again, I see process people (R&D,
production, engineering, QC, QA) clinging to the
FDA’s 1987 process validation (PV) guidance (i.e.,
IQ/OQ/PQ) as a framework for technology transfer
rather than adopting the risk-based 2011 version.
I frequently speak at seminars and conferences
nationwide about the subject of process validation.
When I query the crowd, virtually no one raises
their hand to confirm they are using the 2011
guidance. This is shocking to me. After all, it’s
been five years!
Whether they avoid using it out of habit or
hubris (“we know our processes better than
regulators”), it is, in my opinion, like playing with
a loaded gun. Before I explain why, let’s define
technology transfer, and why it is such a critical
step in the lifecycle of a drug (figure 1), or, more
importantly, in the processes that produce drugs.
Figure 1: For a typical research-based pharmaceutical company, drug
discovery and development can be broken down into distinct stages.
Technology Transfer: 10,000-Foot View
Technology transfer is now specifically an element
of design and development for pharmaceutical
drugs; it’s governed by ICH Q10. In the
pharmaceutical industry, technology transfer can
mean many things:
• The processes that are needed to transfer all of
the information and technology necessary to
manufacture a drug product consistently
• The process of taking a drug from R&D to
full-scale commercialized product
• The process by which a developer of a drug
makes the drug available to a commercial
partner (e.g., CMO, compounding pharmacy,
or supplier) that will exploit or manufacture
• The process of moving a drug from one
process train to the next—e.g., from base