No second chance for a first impression - inspection result by a European supervisory agency

Recommendation

23-25 April 2024

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The publication of GMP defects in warning letters by the US FDA has been known since the 1990s. For some years now, there has also been the European Eudra GMDP database, in which Non-Compliance results are published.

The Maltese competent authority has performed an initial inspection at the site of an Indian manufacturer and packer of solid and semi-solid dosage forms in March 2018. This inspection resulted in a Non-Compliance Statement regarding GMP.

What defects were found during this initial inspection?

Overall, the Non-Compliance Report lists a total of one "critical", six "major" and 11 "other" deficiencies. The falsification of documents has been rated as a critical deficiency. The major deficiencies listed are

• an insufficient pharmaceutical quality system,
• an insufficient documentation system,
• deficiencies in the control of cross-contamination,
• manufacturing deficiencies,
• qualification and validation deficiencies and
• supplier release deficiencies.

The agency's conclusion is simple: this facility is not to be accepted as a manufacturing site in authorisation or variation applications in the EU. There is no second chance for a first impression, psychologists say. That also applies to GMP inspections. Especially during an initial inspection, the impression conveyed should be such that you don't have to "fight" against it in every inspection that follows.

Please see the EudraGMDP Database for more information.