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News dal mondo

23

Nov

Frequent Deficiencies In GMP Inspections

If a film were made on GMP inspections, it could be titled GMP Inspections Feel like Groundhog Day. It is sometimes almost astonishing how often companies "commit" similar or even the same mistakes — in (almost) always the same places. Some countries, e.g., the U.K. and Brazil, publish deficiency statistics at irregular intervals, e.g., MHRA GMP Deficiency Data 20191 or Quality of medicines: Deficiencies found by Brazilian Health Regulatory Agency (ANVISA) on good manufacturing practices international inspections.2

But what do such statistics actually say? Do they really reflect the areas where companies are making the most or most serious mistakes, as indicated in the MHRA introduction? Or do they perhaps rather reflect the priorities of the respective authorities? Or perhaps also the most recent regulatory changes?...[Bioprocess]

01

Feb

FDA Updates Policy Manual on Voluntary Withdrawal of Approved ANDAs

The FDA has updated its Manual of Policies and Procedures (MAPP) concerning receiving and processing...

01

Feb

EMA update on shortages of antibiotics in the EU

EMA's Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) met...

01

Feb

EMA pubblica la linea guida su classificazione dei medicinali veterinari ai fini della prescrizione

Il Comitato per i medicinali veterinari (CVMP) dell’EMA ha adottato la Guideline on the application...

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