Issue: September / October 2022

Agile supply chain management and blockchain survey

While blockchain was originally designed for secure digital transactions, it has now gained traction in a variety of organizations as well where methodologies such as agile have been enabling true digital transformations.
This paper aims to explore whether blockchain and agile supply chains can contribute to healthcare and pharmaceutical innovation, as well to better understand future trends.
Consequently, we hope to provide strategic insights into major issues healthcare and pharmaceutical companies face, such as counterfeiting and anti-tampering measures, as well as a number of strategic options they are considering, such as agile supply chain management.
As a first step, we reviewed the available literature available to develop an initial theme understanding of the challenges, and the adopted strategies and connections between blockchain and innovation in supply chain management.
By analyzing network analysis results and understanding respondents’ relationships and connections, we can reveal how blockchain and agile supply chain management are interconnected.

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Sustainable, efficient manufacturing is driven by data – Key insights help you reduce the environmental footprint of your operations

The pharmaceutical sector is here to help people live healthier lives. But without a healthy planet, this action is compromised. Therefore, pharmaceutical manufacturers should act now to reduce their emissions and contribute to ambitious net zero targets. By adopting data-driven technologies that characterise Industry 4.0, such as Process Analytical Technology (PAT), companies can reduce the environmental impact of their processes and products. They can also futureproof their facilities, improving their profitability and competitiveness in an increasingly challenging and demanding marketplace.

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Streamlining analytical method development with a focus on genotoxic impurities – Developing analytical methods for a range of genotoxic impurities

Development of chromatographic methods for the determination of genotoxic (GTI) or potential genotoxic (PGI) impurities can be time consuming and laborious. Having a generic approach to a method development strategy can aid in the generation of a suitable method in a shorter space of time. Several different approaches to method development are possible. This paper provides an overview of method development strategies to generate a suitable, reliable, robust, and even validatable method for the determination of genotoxic impurities. The discussion includes several examples of successfully developed and validated methods for a range of genotoxic impurities, including nitrosamines, by liquid chromatography (LC) and gas chromatography (GC).

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Excipient Sustainability – A user and a supplier perspective

To achieve their sustainability ambitions excipient users need to access excipients produced with lower embedded GHG emissions, little or no waste produced and with minimal impact on water quality and availability. As such, in the short-term excipient producers need to optimise processes and switch to renewable or low carbon sources of energy. To achieve the long-term ambitions of the pharmaceutical sector, excipient users and suppliers need to collaborate and share data to identify ways to make step change improvements and identify ways to deliver net zero ingredients within the confines of current legislation. This article sets out the standards and guidance for environmental sustainability best practise and information exchange through the pharmaceutical supply chain.

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Qualifying the EXCiPACT GMP Certification Scheme as a provider of 3rd party audit reports and GMP Certificates

There has always been a regulatory requirement for Pharmaceutical manufacturers to audit their starting material suppliers, but with increasing and sustained use of 3rd party audit solutions, pharmaceutical manufacturers will need to qualify not only the excipient manufacturer but also the 3rd party certification scheme owner and any associated organisations that perform the audits. The use of the new IPEC GMP Certification Scheme Certification Body Qualification Guide by EXCiPACT is used to explain an efficient means of qualifying these organisations.

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Mavacamten

This month we will present synthetic strategies towards the synthesis of mavacamten, used to

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