GMP News - Quality Assurance

The EU Commission has published a revision of the "Compilation of Union Procedures on Inspections and Exchange of Information". This is the eighteenth revision. It mainly involves editorial changes, a few adjustments and two new documents.

In the course of an expansion, the IRIS platform will also be used by marketing authorisation holders and applicants to communicate with the EMA about GMP inspections.

The frequent occurrence of particles in sterile injection solutions and the inadequate investigation of the cause led to a Warning Letter to a sterile manufacturer in Japan. In addition, data integrity breaks and falsifications had occurred in the environmental monitoring.

The European Commission has proposed further arrangements to respond to possible difficulties in the movement of goods between Northern Ireland and Great Britain

In a recent Form 483 issued as part of an FDA inspection conducted at an Indian sterile manufacturer, the FDA criticized the manual visual inspection, among other things.

Based on the experience of the past years, the FDA has published a new draft guidance that deals with the microbiological control of non-sterile medicinal products and clarifies it by means of case studies.

The new regulatory framework for veterinary medicinal products requires several changes to the EudraGMDP database. One important change is the integration of EudraGMDP into the EMA's Organization Management Service (OMS).