EU Inspection Complaints due to inadequate Handling of OOS Results

Recommendation

23-25 May 2023
Vienna, Austria

Analytical Instrument Qualification
Practical Approaches for USP General Chapter <1058> Compliance in the QC Laboratory

On August 08, 2017, a Statement of Non-Compliance with GMP was published on the Eudra GMDP website for Dr. Reddy's Laboratories Ltd. in India.

The findings from several GMP inspections of the manufacturer showed that the company does not operate in compliance with European GMP requirements. The following deficiencies were viewed as critical:

In hundreds of cases, OOS results were systematically invalidated without traceable or scientifically based root-cause-analysis; the only reason given was "staff-errors".

Deviation and OOS management including protocols-, review- and reporting-systems were designed and executed in such a way that all deviations, incidents and unusual events were systematically not documented.

Furthermore, the cleaning of rooms and direct-product-contact equipment had verifiably not been performed.

The consequences include:

• Recall of already released batches
• No deliveries to the EU until a successful re-inspection has been performed
• Withdrawal of the currently valid GMP certificate

Please also see the complete Eudra GMDP "Statement of Non-Compliance with GMP" for Dr. Reddy's Laboratories Ltd. in India.