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Beyond instruments: streamlining process technology implementation in biopharmaceutical manufacturing

European Pharmaceutical Review

Given that multiple work packages may often start or end together, or else take longer than others ( Figure 1 ), the introduction of new PAT requires assessment and planning by multiple departments. International Council for Harmonisation (ICH), 2008. International Council for Harmonisation (ICH), 2009. Q9 Quality Risk Management.

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Uruguay progresses towards developing its first regulatory agency

Pharmaceutical Technology

Since 2008, the Association of Chemistry and Pharmacy of Uruguay has played an active role in promoting a National Health Surveillance Agency, and in 2020 the government attempted to launch a similar agency but it ultimately failed. How will RFK Jr’s American dream for vaccines play out?

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Radical Transparency or Radical Redundancy? FDA Publishes 200+ Complete Response Letters, Most of Which Are Already Public

FDA Law Blog: Biosimilars

However, the vast majority of the CRLs posted in the openFDA database are already available in the action packages posted on FDA’s Drugs@FDA database and approved biologics product pages. 355(l) ) requires that action packages (which include CRLs, if issued) for approved original NDAs and BLAs (i.e.,

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Halting Europe’s essential medicines manufacturing exodus

European Pharmaceutical Review

The last paracetamol plant in Europe, closed in France in 2008 as it was no longer economically sustainable, marking the exit of paracetamol manufacturing from Europe” The closure of API manufacturing plants in Europe started in earnest 15 years ago.

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Before & After: Pharmacy’s Digital Revolution

pharmacy mentor

56 UK Online Pharmacies in 2008/9 ( Statista ). Automation , (think Prescription Collection Machines , Dispensing Robots and Packaging Machines) significantly decreases the admin, and therefore long-term expenditure on Rx work. The Digital Revolution in numbers: 721 million UK Prescriptions Dispensed in 2005 (Pharmaceutical Journal).

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Extemporaneous Preparation with Unknown Stability

RX Note

Today, stability information can be obtained from manufacturer’s labelling information (such as in the package insert), the USP compounding monographs, or peer-reviewed articles and references , such as articles in American Journal of Health-System Pharmacy, the International Journal of Pharmaceutical Compounding.

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Eye Preparations

RX Note

On the other hand, a 2008 study concluded that inadequate refrigeration and prolonged shelf-lives of chloramphenicol generics collected from Delhi and Chennai are associated with very high levels of chloramphenicol thermal breakdown product. In year 2020, there is few interesting findings that I came to realize.