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Gert Moelgaard is Head of Strategic Development at NNE Pharmaplan. (Bilder: NNE Pharmaplan)
The Future of Pharmaceutical Production?

The Process Validation Trend — Preparing for the Future

In January 2014 the "new" FDA process validation guide celebrated its 3 years anniversary - and in February the European Commission launched EMA's draft to a new European Annex 15 for Validation and Qualification in the GMPs. However, although Annex 15 is only a draft, we already know enough to prepare our validation and qualification approach for the future. Actually some of the new practices are already becoming regulatory expectations - sometimes with significant impact on observations or even warning letters for pharmaceutical companies.

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