PharmaceuticalOutsourcingQ42020 - 17


Real-time schedules for a QC lab can be synchronized and adapted
to sense and respond to live anomalies in the plant, allowing for
schedule editing and re-optimization. Smart grouping of tests can
also increase efficiency.
Process Optimization: Greater operational consistency can be
achieved using advanced analytics. Batch multivariate analysis
models and predictive control strategies can be constructed based on
design-of-experiment (DOE) principles to control and realize higher
yields. Potential sources of product losses can also be identified early
on to reduce variability.
Integration of advanced analytics to control the batch trajectory and
enable consistent yield improvement has the potential to increase
yield by 30% or more, which would also result in optimized plant
revenue and decreased costs.
Maximized Plant Throughput: Unplanned maintenance and
equipment downtime leads to excessive costs and disruptions,
resulting in lost batches and reduced throughput overall. Equipment
health tracking and fault classification can be aligned with corrective
action and prescription, and an integrated knowledge system can be
combined with dynamic maintenance scheduling.
The ability to predict quality events with adequate time for response
increases maintenance efficiency, reduces human errors and
unplanned downtime, and can result in higher OEE and increased
manufacturing throughput.
100% Visual Inspection: Using smart design, manufacturers can
achieve 100% visual inspection in real-time without the need for
large, expensive machines.

Two Avenues for Adoption
Despite the growing list of benefits, roadblocks remain for Pharma 4.0
adoption due to the controlled nature of the industry. For products
and processes that already have regulatory approval, the risk can
often outweigh the rewards of making any change or upgrade to
the process. But instead of asking " if " Pharma 4.0 should be adopted,
today's manufacturers are more focused on finding out " how " to start
adopting Pharma 4.0.
Whether it is for a manufacturing plant with thousands of unit
operations and 10-20 recipes per unit, or one module within a larger |


facility, today's advanced digital tools and technologies offer a myriad
of efficiencies that are hard to ignore. Two potential avenues for the
adoption of smart solutions include:

Integrating them as part of the addition of new manufacturing lines/facilities to produce new products.
Implementing them in non-good manufacturing
practice (GMP) laboratories where the benefits of new
technologies can be fully evaluated and validated for
commercial application.

Realizing the Future in the Present
In essence, integrated data solutions and digital tools transform
connected, contextualized data into knowledge that can be used
to take action to improve manufacturing processes and realize
the future now. These systems leverage experience gained in the
semiconductor and electronics industries to improve productivity
and reduce waste. Tools that feature modules to cover process,
maintenance, scheduling, and inspection are designed to help
pharmaceutical manufacturers achieve advanced manufacturing
goals related to improving process performance, equipment health,
knowledge management, and scheduling.
Working with real-time data improves plant efficiency via continuous
plant activity monitoring and predictive performance. Whether
on site or offsite, prescriptive actions can help to improve visibility,
quality, safety, yield, and throughput while reducing cycle times to
increase profitability.
Within just two to three months of adopting Pharma 4.0 concepts,
companies can often see double-digit production improvements
that translate to better quality and safety for the most important
customer: patients in need of safe and cost-effective medicines.

1.	 American Pharmaceutical Review:
2.	 McKinsey:
3.	 McKinsey:

| October/November/December 2020 Featured-Articles/333897-Towards-Pharma-4-0-Leveraging-Lessons-and-Innovation-from-Silicon-Valley/ our-insights/how-pharma-can-accelerate-business-impact-from-advanced-analytics our-insights/digitization-automation-and-online-testing-the-future-of-pharma-qualitycontrol#


Table of Contents for the Digital Edition of PharmaceuticalOutsourcingQ42020

Editor's Message
Editorial Advisory Board
CN Perspectives
Social Media Connections
Insider Insight - Price
Insider Insight - Ventura
Contract Manufacturing
Supply Chain
Contract Manufacturing
Interview with Yourway
Supply Chain
Clinical Trials
Supply Chain
Analytical Testing
Supply Chain
Clinical Trials
Analytical Testing
Horizon Lines
Industry News
Advertiser's Index
PharmaceuticalOutsourcingQ42020 - Cover1
PharmaceuticalOutsourcingQ42020 - Cover2
PharmaceuticalOutsourcingQ42020 - 1
PharmaceuticalOutsourcingQ42020 - Editor's Message
PharmaceuticalOutsourcingQ42020 - 3
PharmaceuticalOutsourcingQ42020 - 4
PharmaceuticalOutsourcingQ42020 - 5
PharmaceuticalOutsourcingQ42020 - Editorial Advisory Board
PharmaceuticalOutsourcingQ42020 - 7
PharmaceuticalOutsourcingQ42020 - CN Perspectives
PharmaceuticalOutsourcingQ42020 - Social Media Connections
PharmaceuticalOutsourcingQ42020 - Insider Insight - Price
PharmaceuticalOutsourcingQ42020 - 11
PharmaceuticalOutsourcingQ42020 - Insider Insight - Ventura
PharmaceuticalOutsourcingQ42020 - 13
PharmaceuticalOutsourcingQ42020 - Contract Manufacturing
PharmaceuticalOutsourcingQ42020 - 15
PharmaceuticalOutsourcingQ42020 - 16
PharmaceuticalOutsourcingQ42020 - 17
PharmaceuticalOutsourcingQ42020 - Supply Chain
PharmaceuticalOutsourcingQ42020 - 19
PharmaceuticalOutsourcingQ42020 - Contract Manufacturing
PharmaceuticalOutsourcingQ42020 - 21
PharmaceuticalOutsourcingQ42020 - Interview with Yourway
PharmaceuticalOutsourcingQ42020 - 23
PharmaceuticalOutsourcingQ42020 - Supply Chain
PharmaceuticalOutsourcingQ42020 - 25
PharmaceuticalOutsourcingQ42020 - 26
PharmaceuticalOutsourcingQ42020 - 27
PharmaceuticalOutsourcingQ42020 - 28
PharmaceuticalOutsourcingQ42020 - 29
PharmaceuticalOutsourcingQ42020 - Clinical Trials
PharmaceuticalOutsourcingQ42020 - 31
PharmaceuticalOutsourcingQ42020 - 32
PharmaceuticalOutsourcingQ42020 - Roundtable
PharmaceuticalOutsourcingQ42020 - 34
PharmaceuticalOutsourcingQ42020 - 35
PharmaceuticalOutsourcingQ42020 - Supply Chain
PharmaceuticalOutsourcingQ42020 - 37
PharmaceuticalOutsourcingQ42020 - 38
PharmaceuticalOutsourcingQ42020 - 39
PharmaceuticalOutsourcingQ42020 - Analytical Testing
PharmaceuticalOutsourcingQ42020 - 41
PharmaceuticalOutsourcingQ42020 - 42
PharmaceuticalOutsourcingQ42020 - 43
PharmaceuticalOutsourcingQ42020 - Supply Chain
PharmaceuticalOutsourcingQ42020 - 45
PharmaceuticalOutsourcingQ42020 - 46
PharmaceuticalOutsourcingQ42020 - 47
PharmaceuticalOutsourcingQ42020 - Clinical Trials
PharmaceuticalOutsourcingQ42020 - 49
PharmaceuticalOutsourcingQ42020 - 50
PharmaceuticalOutsourcingQ42020 - Analytical Testing
PharmaceuticalOutsourcingQ42020 - 52
PharmaceuticalOutsourcingQ42020 - 53
PharmaceuticalOutsourcingQ42020 - Horizon Lines
PharmaceuticalOutsourcingQ42020 - 55
PharmaceuticalOutsourcingQ42020 - 56
PharmaceuticalOutsourcingQ42020 - 57
PharmaceuticalOutsourcingQ42020 - Industry News
PharmaceuticalOutsourcingQ42020 - 59
PharmaceuticalOutsourcingQ42020 - 60
PharmaceuticalOutsourcingQ42020 - 61
PharmaceuticalOutsourcingQ42020 - 62
PharmaceuticalOutsourcingQ42020 - 63
PharmaceuticalOutsourcingQ42020 - Advertiser's Index
PharmaceuticalOutsourcingQ42020 - Cover3
PharmaceuticalOutsourcingQ42020 - Cover4