2023-11-07 06:00:00
Coming into force in August 2023, Annex 1 of Good Manufacturing Practices (GMP) on the manufacture of sterile medicines lists in particular the objectives to be achieved in terms of visual inspection of injectable products. And it gives recommendations on the methods to use to achieve this. This text complements the European Pharmacopoeia in which particulate contamination of parenteral products is discussed in a few lines in chapter 2.9.20. However, European regulations on candling still have gaps. “In fact, the text which often serves as a reference for the visual inspection of medicines injectables in Europe, this is the chapter of the American Pharmacopoeia »notes Christophe Assire, co-founder of QP Pharma, a consulting and service company in the pharmaceutical industry.
“Candling is a very complex production step, halfway between production and quality control; I think there should be an annex reserved for visual inspection! », advocates Ludovic Prost, general director of QP Pharma. In the meantime, players in the pharmaceutical industry are taking the lead. Despite regulatory shortcomings, they are innovating to optimize the visual inspection of sterile parenteral products to ensure better patient safety while ensuring their economic viability. And although it is not explicitly mentioned in European texts, automatic mirage crystallizes a large part of the innovations. “In France, the trend is towards an increase in automatic visual inspection”says Romain Veillon, global expert in visual inspection at GSK.
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