Polydrug API Plant found to have 17 breaches of cGMP requirements at its Maharashtra plant
The agency for medicinal products and medical devices of the Republic of Solvenia (Jazmp) conducted inspection of Polydrug API India based Plant. During the inspection inspector observed 17 breaches of current good manufacturing practices at its facility. The agency for medicinal products and medical devices of the Republic of Solvenia (Jazmp) explained its concern on European Union’s Eudra GMP database. Out of 17 breeches five of them were described as major including customer complaints that were “deliberately unregistered in the official logbook”. The affected API include the beta blocker metoprolol tartrate and metoprolol succinate, ferrous fumarate and the Pfizer- developed antifungal fluconazol, which is on the World Health Organisation (WHO) essential medicine list. Other breaches include failure to address risks of cross contamination for APIs sent out to micronisation subcontractor” both of which pose a potential risk for the patient.
The European Directorate for the Quality of Medicine & Healthcare has suspended Certificate of Suitability (CEP) for the seven active pharmaceutical ingredient made at the three factories of the Polydrug site.