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By PharmaCompass
2018-12-27
Impressions: 251 Article
In 2017, an inspection by Italian health authorities at the API manufacturing facilities of Kores (India) Limited uncovered “serious GMP non-compliance”. The inspectors found major deficiencies related to electronic and paper analytical data integrity.
The inspection was performed in the framework of the CEP (certificate of suitability) dossier for the manufacture of ambroxol hydrochloride and the inspection team recommended the suspension of all CEPs from the manufacturing site.
A year later, in October 2018, the French health agency (ANSM) came to inspect the manufacturing process of ambroxol at Kores and once again uncovered data integrity violations. The French inspectors also raised concern over the cross contamination risk pertaining to the production equipment.
As a follow-up to the inspection, the EDQM will consider the withdrawal of the CEPs n°2013-115 Ambroxol HCl, n°2015-012 Ambroxol HCl and n°2015-224 Glimepiride.
The inspection report states that the deficiencies found could affect the other APIs manufactured at the site. These include Doxofylline, Etofylline, Acefylline, Glimepiride, 3-Methylxanthine, 2-Amino-3,5-dibromobenzaldehyde, 8-ChloroTheophylline, 8-Benzyl Theophylline, Theobromine, Acebrophylline, Theophylline, Piperazine/Acepifylline, Pamabrom, Ivabradine HCl, Dorzolamide Hydrochloride.
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