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Common pharma compliance concerns cited by FDA warning letters

European Pharmaceutical Review

Warning letters issued by FDA can be an important source of data to study and analyse violations that occur in pharmaceutical manufacturing. The post Common pharma compliance concerns cited by FDA warning letters appeared first on European Pharmaceutical Review. What can we learn from contamination control failures?

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Cleanrooms-on-demand: a more efficient future for pharma?

pharmaphorum

However, with cleanrooms-on-demand representing a feasible and accessible opportunity for those across pharmaceutical manufacturing, what are the key challenges in adoption and how can we expect the industry to overcome them to reap the rewards on offer? But with a single dedicated cleanroom environment costing around $2.5

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QMS market to value nearly $4b by 2030

European Pharmaceutical Review

A market report by Meticulous Research has reported that rising pressure to reduce overall process costs has meant many pharma and biotech manufacturers are focusing on streamlining their processes by using quality management systems. What is driving adoption of quality management systems in pharma? billion by 2030.

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AbbVie Cork facility €60 million expansion

European Pharmaceutical Review

The company explained that using the latest manufacturing technology will be a key objective at the Carrigtwohill site, particularly to help the aesthetics side of the business. Earlier this year, AbbVie was named Best Workplace for Women and ‘Biopharma Company of the Year’ at the latest Irish Pharma Industry Awards.

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Guaranteeing resilience in vaccine manufacturing

European Pharmaceutical Review

When questioned about which technologies he considered have potential to advance the sector, Chornet emphasised that not only is mRNA as a vaccine technology “a very promising and interesting platform [but that it is] disruptive and a game changer technology for vaccine [manufacturing] and overall biotech.”

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Integrating AI in Pharma Manufacturing: Balancing Technology and Human Expertise

PM360

It’s a powerful technology that, if used correctly, can help us all reach new heights in pharmaceutical manufacturing and beyond. This article will explore how to set yourself up for success when using AI within the pharma manufacturing space. It is easy and understandable to get swept into the hype around AI.

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Cleanroom microbiology: single-temperature incubation for EM

European Pharmaceutical Review

Each strain was selected to take into account: the variability of environmental and human strains in a pharmaceutical production environment strains known for their particular growth conditions, such as growth temperature, invasiveness, growth difficulties, etc (eg, Cladosporium , specific moulds, corynebacteria , Bacillus , etc).