Complaint Handling and Recalls in the Focus of Regulatory Inspections and Enforcement

GMP News
28 November 2007

Complaint Handling and Recalls in the Focus of Regulatory Inspections and Enforcement

Quite revealing are the US Food & Drug Administration's "Enforcement Trends" - as presented at the 2nd ECA GMP-Conference in Heidelberg, Germany (see also GMP News from 22 October 2007). The list of GMP deficiencies illustrated by Center for Drug Evaluation and Research (CDER) Compliance Officer Fred Blumenschein ranked Complaint Investigation number 9. However, "Investigating complaints/issues fully" has been identified by the FDA to be the second most frequent cGMP problem area!

According to John Taylor, Quality and Standards Manager Acting and Group Manager Enforcement and Intelligence at the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA), the situation in the UK is similar. He presented an overview of MHRA inspection results during the ECA Education Course 'How to pass GMP and FDA Inspections/GMP Compliance Auditor'. His results also show Complaint Handling and Recall deficiencies in the Top 10. For example, 6.3% of all API-related deficiencies (U.K. and third countries) are linked to this category, which means number 8 compared to all other observations made at API sites.

In the same context, John Taylor also sees Pharmacovigilance inspections as one of the recent and future challenges in regulatory inspections. Drug alerts are classified in 3 classes:

  • Class 1: Action now
  • Class 2: Action within 48 hours
  • Class 3: Action within 5 days

John Taylor pointed out that the MHRA also issues a Class 4: Caution in Use for some safety information. All Class 1 and Class 2 alerts are notified concurrently to EU/ EEA countries, PIC/S countries, MRA partners and the FDA.

That the pharmaceutical industry continues to improve their respective systems is shown by the fact that the number of suspected defective medicines received by the UK authority MHRA has been constantly increasing from 194 reports in the year 1999 to 410 reports in 2006.

Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)

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