EMA: Q&A on Nitrosamines Updated to Rev. 15

06.04.2023

News

The European Medicines Agency EMA updated its Q&A on nitrosamines on 30 March 2023. The update amends Q&A 22 referring to the approach to control the presence of nitrosamines exceeding the AI during CAPA implementation. It is now indicated that no variation should be submitted to implement temporary above AI (acceptable intake) limits in specifications.

Source:

EMA: Q&A on Nitrosamines

Meet the GMP Compliance Adviser

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

Outsourced Activities in the GDP Environment Part III: Contract Giver and Contract Acceptor

02.11.2026

LOGFILE Feature

Outsourced Activities in the GDP Environment Part III: Contract Giver and Contract Acceptor

For any outsourced GDP activity, there is a need for delimitation of responsibilities between a client (contract giver) and a contractor (contract acceptor). Read more about their roles and responsibilities in the following excerpt from GMP:KnowHow Pharmalogistics (GDP).

02.11.2026

Question of the Week

Who is Qualified to Conduct Self-Inspections within a Company?

Here's the question:

30.10.2026

News

EU: Singapore Added to List of Recognised Third Countries for API Importation

The European Commission recognises Singapore’s GMP requirements and regulatory oversight of active substance manufacturers as equivalent to EU requirements. Once the decision enters into force (15 November), Singapore will join the EU list of recognised third countries for the importation of active substances.

29.10.2026

News

PIC/S/EMA/WHO: New Q&A on Annex 1

The revision of Annex 1 also made it necessary to update the previous PIC/S interpretation document, PI 032-2, “GMP Annex 1 Revision 2008, Interpretation of Most Important Changes for the Manufacture of Sterile Medicinal Products”. Based on a Swissmedic draft from 2023, the joint PIC/S–EMA–WHO working group developed a new Q&A document.

23.10.2026

News

EMA Clarifies Batch Numbering for Parallel-Traded Medicines

EMA updated its GMP/GDP Q&A collection by revising the answer to Question 4 concerning Chapter 5 of the EU GMP Guide. It explains which batch numbers should appear on the packaging of parallel-traded medicines.

19.10.2026

Question of the Week

Why is it Important to use Consistent Microbiological Air Monitoring Methods in Pharmaceutical Cleanrooms?

Here's the answer: