EU: France seeks feedback on draft good preparation practices guidance


EU: France seeks feedback on draft good preparation practices guidance

(Source: RAPS 2019-07-30)

The French National Agency for Medicines and Health Products Safety (ANSM) is seeking feedback on a new guide to the preparation of medicinal products in healthcare establishments.

While many medicines are made in industrial settings under good manufacturing practices (GMPs), some drugs are prepared at healthcare facilities for direct supply to the patients they treat. France established rules covering the preparation of medicines at pharmacies in 2007, but since then global views on the subject have moved on. Most notably, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) published a revised guide to good preparation practices in 2014.

The ANSM guide released for consultation this week follows the same format as the PIC/S document. Both documents detail the requirements and principles that should inform decisions about quality control, personnel, product recalls and other areas involved in the preparation and supply of safe medicinal products by healthcare establishments.

In updating the guide, ANSM has placed greater emphasis on risk assessments. ANSM wants sites that prepare medicinal products to formally assess and prioritize threats to cut the risk of harm. The new guide also features stronger minimum quality requirements, specifically in relation to personnel training and controls.

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