EU issues Non-Compliance Reports for US Company

Recommendation

13/14 December 2023
Berlin, Germany

Root Cause Analysis
A CAPA Workshop on Successful Failure Investigation

The results of inspections performed by EU competent authorities and inspectorates are published in the EudraGMDP database. Negative results can be found in the "Non-Compliance Reports" area.

The U.K. MHRA has now published two Non-Compliance Reports for two sites of the US based company Pharmaceutics International. In both reports it is considered that they do not "comply with the Good Manufacturing Practice requirements referred to in the principles and guidelines of Good Manufacturing Practice laid down in Directive 2003/94/EC ."
 
The inspectors identified two critical deficiencies at the sites in Hunt Valley and Cockeysville, Maryland:

• Failure of organisational and technical measures to minimise the risk cross-contamination between hazardous and non-hazardous products manufactured in the same manufacturing facilities using shared equipment.
• Failure of the quality unit to ensure the effective operation of the quality system.

The second includes a critical failure of change management. Here an unqualified HPLC system was used and the overall approach to production equipment qualification was classified as unacceptable.
Besides that, three major deficiencies were identified:

• Organisational data governance failures including inadequate investigation into previous data integrity failures
• Deficiencies in sterilisation and depyrogenation processes
• Insufficient control of aseptic operations

As a result the current valid GMP certificate was suspended, a recall of product was recommended, (where market alternatives and medical criticality permits) and no future batches of non-critical product will be allowed to be supplied to the EU while the statement of non-compliance remains in force.

Source: Overview of all EudraGMDP non compliance reports