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| home > pmps > winter 2021 > a dose of industrial edge for pharmaceutical manufacturing |
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 PUBLICATIONS |
Pharmaceutical Manufacturing and Packing Sourcer
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The pharmaceutical and life science sector has not escaped the effects of the pandemic, with employees working from home and only critical staff and visitors allowed to visit production sites. We’ve been reminded how fragile the world is, and how something we can’t see can wreak havoc on a global scale. The word ‘biologics’ is now commonplace on the world stage, and biologic manufacturers continue to search for a ‘100% vaccine’, which is an illustration of how the community is coming together to accelerate the response. Governed by strict regulations, few other industry sectors can claim they are regulated as stringently. With a vaccine set to be produced on a global scale, by multiple manufacturers who are under enormous pressure to deliver ‘the antidote’, how can they adhere to FDA regulations and comply with GMP in a fast-moving operation? How can their technical partner help them maximise their value chain?
The key drivers within this sector are well affirmed as: time-to-market, quality/regulations, flexibility, and efficiency. The ability to up-scale from clinical trials of small batches to full production, while maintaining quality, is paramount.
Before the COVID-19 pandemic, the Industry 4.0 evolution had already impacted the way pharma adopts new technologies and digitalises its manufacturing plants. The goal was to remain on top of the game by addressing the well-versed industry drivers. These factors have emanated from market forces, such as our demand for new medicines, new entrants into the market, uncertainty, complexity, and cost.
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News and Press Releases |
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Aceto Establishes Chemical Manufacturing and R&D Capabilities in the US Through Acquisition of IsleChem
PORT WASHINGTON, NY — December 21, 2020 — Aceto, a leading global
virtual manufacturer of specialty materials for life sciences and
advanced technology end markets, announced today its acquisition of New
York-based, IsleChem. IsleChem’s technical, analytical and manufacturing
expertise complements Aceto and expands its value-added offering to
customers.
More info >> |
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White Papers |
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Conveying Medical Guidance in Clinical Trials – A Survey
Europital Medical Consultancy
With the incremental demand for proactive safety surveillance throughout the conduct of clinical trials, the role of Medical Management is at the fore in ensuring the safety and wellbeing of the participants. The complex responsibilities of a Medical Monitor (MM) starts from the design and development phase, through to study close out. Understanding the principle behind the protocol and the prospective medical solution the study would deliver forms the bloodline for the MM role. Often, the MM is the face of contact for both the site personnel and the study team members with regard to medical, safety and scientific issues within the project.
When it comes to medical guidance, the communication channel used to deliver solutions contributes to a large extent in effectively managing decisive situations. Our previous study on acquiring medical guidance from an operations team perspective revealed that e-mails were the most used communication method (see the article, 'Talking Points', in ICT November 2014). In our efforts to further strengthen the mode of medical guidance delivery, we designed a survey to study the existing trend and constraints in this communication chain management, as outlined here.
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