APR Nov/Dec 2022 - 17

« MANUFACTURING
which quality assurance teams can view and make sense of
all the data they're getting from disparate sources internally
and across the supply chain. From this centralized hub,
manufacturers can rapidly analyze the data to make faster,
better-informed decisions not only about the release of
finished products to market, but also about validating
the quality of externally sourced goods and internally
manufactured bulk or finished products. Through the hub,
quality assurance teams can more readily detect deviations
early in the process, and identify erroneous batches, then
track the source of error.
3. Quality by Design. " Quality by design is produced, not
checked " should be the mantra that guides a manufacturer's
approach to batch release. The U.S. Food & Drug
Administration endorsed moving from a " quality after design "
approach to a risk-based approach to pharmaceutical quality
15 years ago. Automation and standardization are critical to
(re)designing products and processes for quality.
4. Strengthening carbon footprint tracking and reporting
capabilities. How does producing a batch right the first
time or a substandard batch impact the company's carbon
footprint? How do suppliers and sub-suppliers compare
in terms of their carbon footprint? What steps could your
company take to minimize the resources - energy, paper
and packaging, transportation, etc. - associated with each
and every product? With so much emphasis being placed
on sustainability, ESG and carbon-reduction, it's vital that
pharmaceutical companies arm themselves with tools
to answer these kinds of questions. They must be able to
collect and track the make-up, and prove the origin, of the
materials and equipment they use, as well as the energy
their operations consume and the emissions they produce,
and they also need to embed KPIs related to these factors
across the business, so they can make decisions accordingly.
Incidents like the tragedy in West Africa provide a powerful reminder
of just how much is at stake for pharmaceutical companies to improve
their batch release processes. Now, with the advent of new approaches
that promise big gains in efficiency and significant reductions in cost,
they have the means and the incentive to do so.
About the Author
Aladdin Mandishah has 15-years experience in the life
sciences industry in continuous improvement roles in
operational excellence and business transformation to
help companies become more resilient, productive and
effective. At SAP he works as a trusted advisor to customers worldwide.
He shares industry best practices which companies can use to transform
into Intelligent Enterprises. Ultimately, it allows them to provide better
experiences for their customers and be more resilient to evolving industry
trends and market conditions.
www.americanpharmaceuticalreview.com |
| 17
True Continuous
Measurement for TOC
Full transparency and better process control
of your pharmaceutical water is achievable
with precise, accurate, and continuous TOC
measurement offered from the 6000TOCi by
METTLER TOLEDO. With the fastest response
times available, you will reduce cost and be
able to maintain the highest quality when it
comes to pharmaceutical manufacturing.
Download the eBook
to Learn More
»
http://www.americanpharmaceuticalreview.com
APR Nov/Dec 2022

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