European Pharmaceutical Review
APRIL 8, 2025
To give examples, such a work package focuses on the identification of regulations (ICH Q2 R2, 3 Q8-Q14, 4-10 FDA PAT guidance, 11 EMA Annex 15 12 ), some of which may be mainly guidance documents with recommendations and flexibility when it comes to PAT.
European Pharmaceutical Review
NOVEMBER 15, 2022
Validation projects have often been documentation-focused exercises, more befitting a grammar exercise than artifacts supportive of regulated activity. The GAMP 5 Second Edition guide emphasises that focus should be on value-adding activities rather than documentation for documentation’s sake.”
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Eye on FDA
AUGUST 2, 2022
There are two means of gaining insight into the agency’s thinking about regulatory issues related to promotional communications by pharmaceutical companies; one is through the issuance of guidance documents, the other is through enforcement. But when it comes to enforcement things have changed greatly over the years.
European Pharmaceutical Review
FEBRUARY 2, 2023
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.
European Pharmaceutical Review
JUNE 12, 2024
European Society of Clinical Microbiology and Infectious Diseases: 2021 update on the treatment guidance document for Clostridioides difficile infection in adults. 2017; 55(7):1998-2008. References van Prehn J, Reigadas E, Vogelzang EH, et al. Clin Microbiol Infect. 2021; 27 (2): S1-S21. McDonald CL, Gerding DN, Johnson S, et al.
Express Pharma
JUNE 20, 2025
Archive design basis documents for all facility, process, and utility decisions. Treat each deviation, complaint, or EM excursion as a rehearsal for an FDA discussion – document decisions, risk rationales, and CAPAs with inspection-grade clarity. Regularly conduct mock inspections using external or cross-site auditors.
European Pharmaceutical Review
FEBRUARY 1, 2024
Even though patients are on existing [statins] that are well-documented and most likely safe and effective, there are many patients who still have cardiovascular disease, the leading cause of death” We are recognising now is that there is great data on how to reduce risk by applying lipid lowering therapy like statins.
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