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11-15 January 2021

published 18 Jan 2021

EMA Q&A update on multiple batch numbers

The EMA has updated its Q&A on Chapter 5 of the EU GMP guide concerning production. Q&A No.2 has been updated and covers the EMA’s recommendations on the use of multiple batch numbers on the packaging of medicinal products. When a bulk product is packaged as several sub-batches, there is usually an element in the numbering format that is common to the bulk batch and finished product batches and ties these together. However, the EMA has discouraged this practice in cases where the bulk batch number and finished product batch number have no obvious connection, barring exceptional cases such as in combination product packages.

Nitrosamine impurities: Lessons Learnt

Following the discovery of the potentially carcinogenic nitrosamine impurities in pharmaceutical products containing sartans in 2018, the European network (EC, EMA and NCAs in the EEA) has engaged in a lessons learnt exercise. The group has made several recommendations to reduce the risk of nitrosamine presence in pharmaceuticals. The recommendations cover topics such as prevention, incident management, market surveillance, communication and international cooperation. The group also evaluated relevant guidelines and determined that certain amendments and clarifications would benefit both pharmaceutical companies and regulators in the nitrosamine assessment process.

The following PharmTech article provides further detail on the European network’s recommendations:

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