Pharmaceutical Quality
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Automation Opportunities Abound for Quality Inspections | Automation World

Automation Opportunities Abound for Quality Inspections | Automation World | Pharmaceutical Quality | Scoop.it
Almost half of the respondents to a recent Automation World survey use little to no automation in quality inspection. Those that do, however
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"Automation moves manufacturers from visual inspection by line operators and QC specialists to automated measurements, Montpas says. “As these devices are getting smarter and the automation pieces and sensors are getting better...we get more accurate data with less human intervention.”

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Pharma’s Great Automation Migration

Pharma’s Great Automation Migration | Pharmaceutical Quality | Scoop.it
Companies should focus on the collection and curation of data because the variables selected could be the game changers when machine learning becomes standard
Christophe Riboulet's insight:

"Now is the time for the businesses to collect and curate data, all while pondering the possibilities that Industry 4.0 could create for the future of the company."

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Deming, Finally! — Part 3 – Celine Schillinger – Medium

Deming, Finally! — Part 3 – Celine Schillinger – Medium | Pharmaceutical Quality | Scoop.it
This is the third of an eight-post series, by Anders Vinther, Sanofi Pasteur Chief Quality Officer and Celine Schillinger, Sanofi Pasteur Head of Quality Innovation & Engagement. Part 1 introduced…
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Excellent series of posts on the Pharma Industry Quality by Celine Schillinger. "Focus on quality first and cost reduction will come as a consequence."

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Improving Manufacturing Product Quality with Flexible Automation & Software - Supply Chain 24/7

Manufacturers can improve quality using flexible automation by improving sanitation, safety & inspection while speeding production, reducing bad parts and increasing consistency.
Christophe Riboulet's insight:

“Vision systems can be a key analytical tool for quality teams,” said Scott Klimczak former president of CHAD Industries. “Not only does an automation inspection process track pass or fail parts but it can also track failure modes. An analysis of a group of similar failures can lead to uncovering issues in the manufacturing process either on site or from a vendor.”

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Digitizing Quality Management is the Name of the Game | Engineering the future|TCS Engineering & Industrial Services Blog

Digitizing Quality Management is the Name of the Game | Engineering the future|TCS Engineering & Industrial Services Blog | Pharmaceutical Quality | Scoop.it
Digitizing quality management helps you consistently deliver quality products within shorter timelines while optimizing costs and efforts
Christophe Riboulet's insight:

"Visibility into real-time defect data will maximize supply chain operations and efficiencies. Toyota uses advanced analytics and advanced process controls (APC) to troubleshoot quality problems in production, in real time. This has minimized scrap and rework and enabled the manufacturer to reduce the cost of quality assurance by 10 to 20%."

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Quality Control under the Industry 4.0

Quality Control under the Industry 4.0 | Pharmaceutical Quality | Scoop.it
Higher technologies and more complicated manufacturing processes used, the quality system concept requires change and modifications to current processes.
Christophe Riboulet's insight:

"The zero defects attitude will require manufacturers to design their own approach for total product control."

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Near-infrared spectroscopy in the pharmaceutical industry | Chemgineering Holding AG

Near-infrared spectroscopy in the pharmaceutical industry | Chemgineering Holding AG | Pharmaceutical Quality | Scoop.it
Scientific Articles Near-infrared spectroscopy in the pharmaceutical industry Efficient process monitoring and quality control with near-infrared in the pharmaceutical process chain. The amount and variety of work in the quality control laboratorie
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Pharma, Robotics and Jidoka: Perspectives from ABB’s Bengt Stom



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Innovation and Continuous Improvement in Pharmaceutical
Manufacturing

Pharmaceutical manufacturing operations are inefficient and costly. The cost of low efficiency is generally not understood or appreciated (e.g., manufacturing costs far exceed those for research and development operations).

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Continuous improvement is an essential element in a modern quality system and it aims at improving efficiency by optimizing a process and eliminating wasted efforts in production. In the current system continuous improvement is difficult, if not impossible. Reducing variability provides a "win-win" opportunity from both public health and industry perspectives, therefore continuous improvement needs to be facilitated.

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Quality Digest Magazine

Quality Digest Magazine | Pharmaceutical Quality | Scoop.it
Christophe Riboulet's insight:

"After 25 years, it’s time to stop accepting this double standard. Defects are not normally accepted events in life; there’s no reason that they should be accepted normally in service or manufacturing organizations. Zero defects have a place in the real world, as the ultimate standard by which all processes should be measured. Settling for less should never be an option."

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Costs of Failure in Product Quality

Costs of Failure in Product Quality | Pharmaceutical Quality | Scoop.it
The authors detail the possible consequences of noncompliance and a lack of quality control.
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Pharma 4.0 – time to rethink manufacturing and quality | Veeva Systems EU Site

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Achieving Manufacturing Excellence

Achieving Manufacturing Excellence | Pharmaceutical Quality | Scoop.it
Moving to the next level of productive, reliable performance in bio/pharmaceutical manufacturing requires a willingness to make changes and create a quality culture.
Christophe Riboulet's insight:

“Automation, data collection, and data handling are part of the informatics movement that is one of the fastest growing areas in manufacturing. Compared to other industries, pharma is well behind the curve in this respect and it represents a huge improvement opportunity for the entire industry,” suggests Marc Bonner

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Using Robotics In Pharmaceutical Manufacturing

Robots are proving advantageous in filling, inspection, packaging, laboratories, and the manufacture of personalized medicine.
Christophe Riboulet's insight:

"Automatic inspection, as part of a robotic system, has the advantage of enabling 100% part inspection."

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Steps to Zero Defects

Steps to Zero Defects | Pharmaceutical Quality | Scoop.it
The idea that you can get to zero defects causes people problems. It sounds impossible. Most people agree with the aim, and are happy with the idea that there are only two numbers to which you should aspire in quality - 0% and 100%, depending on how the target is worded. Aspirations are fine, but…
Christophe Riboulet's insight:

"All work requires inspection, Shingo felt, because no defect is acceptable. If a defect reaches a customer, then that person experiences 100% defects, because the only product they experience is defective. That is not acceptable, said Shingo, so all defects must be found – you cannot, he argued, rely on statistical quality control, or sampling inspection alone."

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How Pharma Companies Game the System to Keep Drugs Expensive

How Pharma Companies Game the System to Keep Drugs Expensive | Pharmaceutical Quality | Scoop.it
The promise of generics remains unfulfilled.
Christophe Riboulet's insight:

"Although makers of a branded drug are using a variety of tactics to create barriers to healthy competition, generic drug companies are often not helping their own case. In 2015, there were 267 recalls of generic drug products—more than one every other day. These recalls are for quality issues such as products not dissolving properly, becoming contaminated, or even being outright counterfeits."

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The Pharma Digitalization: the new Pharma Reality, beyond the Pill | Make Helsinki

The Pharma Digitalization: the new Pharma Reality, beyond the Pill | Make Helsinki | Pharmaceutical Quality | Scoop.it
Christophe Riboulet's insight:

"The FDA’s a vision for the 21st century pharmaceutical quality manufacturing is a maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high quality drugs without extensive regulatory oversight "

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PAT: “Gateway Drug” to the 21st Century for the Pharma Industry

Process analytical technology paved the way for continuous manufacturing.
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Indian Pharma Is Committed to the Future, Says Biocon Managing Director

Investment in talent and infrastructure, more quality-by-design skills, and increased communication with global regulators will be needed to combat compliance issues at API and drug manufacturing facilities in India.
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The Fate of Pharma | Healthcare Packaging

The Fate of Pharma | Healthcare Packaging | Pharmaceutical Quality | Scoop.it
The pharmaceutical industry is under pressure to lower drug prices, improve product quality and accelerate time to market. Here’s how Big Dat
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Yet Another Post About Poka-Yoke

Yet Another Post About Poka-Yoke | Pharmaceutical Quality | Scoop.it
A week ago, José Roberto Rolim Nunes  started a new discussion on the TPS Principles and Practice discussion group on LinkedIn by asking “What is Poka-Yoke?” As of today, it has had 42 …
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Defects can be a driver for the creation of a lean culture

Defects can be a driver for the creation of a lean culture | Pharmaceutical Quality | Scoop.it
The fifth article in the series Hazards on the road to lean analyzes the role of quality defects in helping to develop a lean management culture.
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It’s Time for Quality Leadership in the Pharmaceutical Industry

It’s Time for Quality Leadership in the Pharmaceutical Industry | Pharmaceutical Quality | Scoop.it
The way that we have set about delivering this quality has led to an environment where improvements to processes and systems are typically gradual and linear — focusing on reducing waste and variab…
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The Cost of Poor Quality, Too High a Price?

The Cost of Poor Quality, Too High a Price? | Pharmaceutical Quality | Scoop.it
Assessing the cost of poor quality doesn’t just prevent disasters; it’s good for business.
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