GMP News

EMA on potential Impact of Coronavirus

The EMA and its partners are closely monitoring the potential impact of the outbreak of the novel coronavirus disease (COVID-19) on pharmaceutical supply chains into the EU.

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Foreign Particles in Oral Dosage Forms can also Cause Warning Letter

A US-American medical manufacturer has received a Warning Letter from the FDA due to foreign particles in a solution for oral application and especially regarding the handling of this incident. Besides, further deficiencies were observed during the inspection, such as errors in the evaluation of HPLC data and data integrity in the laboratory in general.

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EU GMP Annex 21 finally published

Annex 21 to the EU-GMP Guidelines (Importation of medicinal Products) has been published as a draft. It summarises the GMP requirements for importers of medicinal products.

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Covid-19: FDA Postpones Domestic and Foreign Inspections

In response to the COVID-19 outbreak, FDA has decided to postpone most foreign inspections until the end of April.

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European Pharmacopoeia: New Chapter on Visual Inspection for Visible Particles Comes Into Force

The new chapter 5.17.2 in the European Pharmacopoeia "Recommendations on testing of particulate contamination: visible particles" was already published for comment in autumn 2018 (Pharmeuropa 30.4). The comments and feedback received have been considered by the Expert Group 12 of the EDQM, and the chapter is coming into force.

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