APR Nov/Dec 2022 - 14

»
MANUFACTURING
»
Right First Time:
Unlocking the Competitive
Benefits of Better
Batch Release
Aladdin Mandishah
Global Life Sciences Industry Solutions Manager
SAP
The soul-searching began soon after reports emerged this fall linking
the tragic deaths of 70 children in the West African nation of Gambia
to cough syrups produced in India. How could incidents like this be
prevented from happening again?
Finding an answer to that question could very well depend on making
strides on two fronts. The first is strengthening regulatory oversight
of manufacturers in certain jurisdictions, a difficult proposition given
the complex political, market and stakeholder dynamics in play.
The second is improving batch release processes and practices, so
contaminated or substandard medical products never make it out
of the production facility and onto the shelves. That could be a more
straightforward undertaking, for a variety of reasons. First, of course, is
the desire to avoid tragic outcomes like what occurred in Gambia. As
infrequent as incidents like this are, the damage they inflict in terms of
human life is immeasurable. What's more, they undermine consumer
confidence and extract a huge cost on the individual companies and
brands involved.
These
aren't
the
only
compelling
reasons
for
pharmaceutical
manufacturers to take steps internally to streamline and strengthen
the practices and processes behind batch release. Among the others:
Meeting carbon footprint, sustainability and ESG (environmental,
social and governance) goals, priorities and requirements -
and in doing so, potentially gaining a competitive advantage.
Pharmaceutical companies are feeling pressure on multiple fronts
to behave more sustainably. Using integrated, automated and
standardized batch release processes instead of the siloed, manual
processes that are common today can lead to substantial reductions
in carbon footprint by facilitating faster supply chains, reducing
inventory levels, reinforcing right-first-time releases and reducing
product recalls.
Avoiding the potentially large costs associated with recalling and
disposing of a substandard or contaminated batch. According to
estimates from McKinsey, a single warranty or recall process can cost
a medical manufacturer up to $600 million (exclusive of recall-related
costs like lawsuits).
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| November/December 2022
APR Nov/Dec 2022

Table of Contents for the Digital Edition of APR Nov/Dec 2022
