APR Nov/Dec 2022 - 16

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MANUFACTURING
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Reducing cycle time to bring products to market faster. Based on
our internal analysis at SAP, streamlining and digitizing batch release
processes can reduce overall batch review cycle time by more than
90%, enabling companies to bring more products to patients, faster,
with shorter order fulfillment lead times. At one large manufacturer, for
example, batch review processes that used to take a quality assurance
team of five people 40 hours now take a single person just one minute
using intelligent digital tools.
Reducing production and inventory carrying and scrappage costs.
The big efficiency gains that come from accelerating the batch release
cycle time can significantly reduce operating costs by lowering the
cost of meeting quality standards. We calculate that a 5% reduction
in quality costs for a company with operating expenses of $80 - $100
million can result in an average of $5 million in sustainable cost savings.
What's more, shorter order fulfillment lead times also can translate into
as much as 25% reductions in inventory carrying costs.
As compelling as benefits like these are, for pharmaceutical companies
to capture them they have to find ways to fix the well-documented
shortcomings of current batch release approaches. Here's a look at
how they might go about doing so:
1. Boosting automation and standardization. To understand
just how labor-intensive and error-prone the batch release
process is, consider that today close to half - 48% - of
life sciences companies use manual processes for batch
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| November/December 2022
release and 35% check data in multiple siloed systems
during the batch release process, according to our internal
research. Here's where intelligent, machine-learning- and
AI-driven automation tools can overcome those obstacles,
giving quality assurance teams the ability to quickly collect
data from disparate sources: downtime logs, line clearance
logs, equipment and room cleaning logs, calibration labels,
environmental monitoring data, deviations, serialization,
etc. They then can draw insight from that data, evaluate
exceptions and facilitate faster, more informed decisions. With
a greater reliance on automation, manufacturers can shift to a
review-by-exception approach to evaluating batches.
There's also an opportunity for manufacturers to bring muchneeded
standardization within and across quality teams and
departments, as well as along the supply chain (including
contract manufacturers and suppliers) by integrating a variety
of automated checkpoints into the process to ensure adherence
to a set of common practices, processes, systems and functions.
This in turn reinforces thresholds, parameters, workflows, etc.,
that lead to faster, more compliant batch outcomes.
2.
Improving visibility internally and across the supply
chain. Perhaps the most critical missing piece for more
efficient and compliant batch release is a central hub from
APR Nov/Dec 2022

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