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Background Information
Outcome CV™ was developed by specialists from Syska Hennessy
Group’s Commissioning Team along with Validation Team experts
from BioMetics, Inc.
Outcome CV was created based on the findings of a tremendous
research project in which companies were studied to determine
where their
true challenges lie. One of those challenges has been the confusion
that surrounds start-up style commissioning and true commissioning.
While commissioning is an integral part of utilizing the building
support systems and process systems, it is traditionally wedged
between the end of construction and beginning of validation. As
a result, any commissioning that is performed does not support
validation. Many firms are using in-house commissioning teams who
have limited experience. Consequently, a myriad of problems are
uncovered during validation, further delaying and complicating
this important process. Costs skyrocket and put pressure on an
already strained budget. These costly delays also affect a product’s
speed to market and take away from valuable patent time.
Case Study
Syska Hennessy Group and Biometics, Inc., give an example of
an East Coast Pharmaceutical Manufacturing Facility who uncovered
various problems in the validation processes, which led to an
untimely completion and a huge loss in revenue.
According to Shaun McCormack of BioMetics, Inc., many problems
were discovered in the validation process:
- The commissioning reports were incomplete. This resulted
in voids in the documentation due to an incomplete or missing
review.
There was no attention to detail, which made the reports
useless for validation.
- The systems were not operating properly. The original commissioning
plan was too simplified and did not relate to actual use
and validation of equipment.
- The systems were not operating according to original
specs.
- Protocol generation was delayed because of improper documents.
Turnover binders, cut sheets and test reports were done
generically without any customization for equipment use. The
equipment,
instead of running correctly, was barely running.
- There was continuous retesting to complete validation.
Due to the issues above that were found during initial
testing, the
work to fix the issues, retesting after documentation and
work completed, caused major overruns on time and money.
“You would be amazed how often this is the scenario we
run into on a validation project,” added McCormack.
Paul Liesman of Syska Hennessy Group says all of these issues
could have been uncovered during the commissioning process and
resolved prior to validation. The result in this case was an
extension of 20 months to complete validation of this facility.
The validation cost originally budgeted at approximately $800,000
escalated to $2.4 million. Then there’s the consideration
of loss of product revenue estimated to be about $16 million,
and valuable patent time running out on this drug. The additional
actions required to make commissioning relevant for validation
are relatively modest. If properly planned, commissioning can
assure an easier and more productive validation cycle.
Leisman also noted the following:
With today’s complex design and construction projects,
most owners are recognizing the value of a rigorous commissioning
program. The additional complexities and critical requirements
present in pharmaceutical manufacturing facilities make commissioning
a much more required phase to most projects. Experienced commissioning
providers will understand the exact technical and procedural
items to add to normal commissioning procedures that will integrate
with the validation activity. This integrated approach of commissioning/validation
will yield a significantly shorter facility construction project
where speed to market is the key goal.
“Based on our industry experience, we have developed Outcome
CV™ which resolves the technical and coordination issues
which cause projects to become delayed and over budget,” said
Liesman.
The chart below clearly shows the cost overruns in this case.
The black indicates the budgeted validation costs. The red indicates
the amount over budget from original estimates.
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