Are Metal Detectors mandatory in Tableting?
Recommendation
28/29 January 2025
Generation, Monitoring & Compliance
The European Medicines Agency (EMA) maintains a site with answers to frequently asked questions regarding GMP. This site has been updated this year and now also provides an answer to the question with regard to the mandatory use of metal detectors in tableting.
Metal particles may come from raw materials or, as in the case of tableting, from the equipment - for example, due to damage of the moving metal parts in a press. In cases where this is possible, the Agency recommends the use of metal detectors. If there is no routine use of metal detectors, the company needs to demonstrate that their use is not necessary. This might be difficult in practice.
Find this and more interesting GMP answers on the EMA's Q&A site.
Related GMP News
06.11.2024FDA Warning Letter to a US Manufacturer of Medical Gases
30.10.2024WHO Guidance on Wastewater and Solid Waste Treatment in the Antibiotics Production
23.10.2024Warning Letter to Indian sterile Manufacturer due to Cross-Contamination and Particles
16.10.2024Do Parenterals have to be 100% free of Particles?
02.10.2024Does Purified Water have to be tested for Endotoxins?
18.09.2024FDA issues Warning Letter to Cell Gene Therapy manufacturer