Are Metal Detectors mandatory in Tableting?

Recommendation
16-18 September 2025
Barcelona, Spain
Organisation of a GMP-compliant Site Change
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
25.06.2025Deficiencies in the Water System: Warning Letter to US Manufacturers of OTC Products
11.06.2025Warning Letter to Chinese Manufacturer due to serious Sterility and Hygiene Deficiencies
04.06.2025FAQs regarding Cross Contamination
04.06.2025GMP Deficiencies at French Sterile Manufacturer
14.05.2025Process Validation and Pharmaceutical Water Deficiencies at a US Manufacturer
07.05.2025Another FDA Warning Letter for Indian API manufacturer