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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. Such studies can also help companies prepare for their upcoming inspections by enabling them to identify and rectify any issues.

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New medicines manufacturing centre to enhance UK talent

European Pharmaceutical Review

It will build on existing infrastructure and best practice, and deliver sustainable, end-to-end training provision. Enhancing talent in pharmaceutical manufacturing “Talent and skills are fundamental to successful innovation and industry growth.

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Revised Annex 1 now effective

European Pharmaceutical Review

The European Commission (EC)’s revised Annex 1 – Manufacture of Sterile Medicinal Products is now effective in the EU. As of 25 August 2023, pharmaceutical manufacturers are required to implement the GMP regulation into cleaning and bio-decontamination procedures for these products. What is included in the new revision?

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QMS market to value nearly $4b by 2030

European Pharmaceutical Review

Most of the quality management systems providers are focusing on capturing these large pharmaceutical markets. Also noted in the report was the shift towards cloud-based systems.

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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. Reducing the facilities carbon impact will also be supported by the expansion.

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Understanding endotoxin cartridge testing: frequently asked questions

European Pharmaceutical Review

For a trained and qualified analyst, the ability to pipette 25µL of sample accurately across four wells for a cartridge is no more difficult than accurately pipetting 100µL of sample, or the 10µL spike, used in traditional kinetic methods. First, accuracy of pipetting is a critical aspect of all BET methods, not just Endosafe cartridges.

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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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