What is an alert limit, and what happens when it is exceeded?

01.06.2020

Question of the Week

Alert limit: A predetermined value somewhat outside the normally expected tolerance band. If exceeded, intensified supervision according to a pre-determined plan should be triggered.

[GMP Compliance Adviser, Chapter 3.K]

Would you like to discover more?

The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business.

The demo access is non-binding and ends automatically.

Test it now for free

You may also be interested in the following articles:

EMA: Q&A on QP Certification Without Physical EU Import

15.12.2025

News

EMA: Q&A on QP Certification Without Physical EU Import

The EMA has published a new Q&A addressing QP certification for batches that are neither manufactured within the EU/EEA nor intended for the EU/EEA market, and that are not physically imported into the EU/EEA.

EU: Agreement on the Pharmaceutical Package

On 11 December, the European Commission, the European Parliament, and the Council of the European Union reached a provisional agreement to update Europe's medicinal products regulatory framework.

EMA: Updated Q&As for Biological Medicinal Products

EMA has updated its Q&A on biological medicinal products, addressing topics that previously required clarification or were subject to differing interpretation. The latest revision adds six new questions and updates several existing answers.