The agency for medicinal products and medical devices of the Republic of Slovenia (Jazmp) logged its concerns on the European Union’s Eudra GMP database last night, explaining that they are based on an inspection conducted on March 18.
The regulators said its inspectors observed 17 breaches of current good manufacturing practices at the facility, five of which it described as ‘major’ including that customer complaints were “deliberately unregistered in the official logbook.”
Other transgressions included that access to quality records is not controlled and that Polydrug failed 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 Medicines & HealthCare (EDQM) has suspended certificates of suitability (CEP) for the seven active pharmaceutical ingredients (APIs) made at the three factories at the Polydrug site.
The affected APIs include the beta blockers metoprolol tartrate and metoprolol succinate, ferrous fumarate and the Pfizer-developed antifungal fluconazole, which is on the World Health Organisation’s (WHO) essential medicines list.
Mumbai-headquartered Polydrug has yet to comment on the CEP suspension and all of the APIs involved were still listed as available on its website when this article was published.
The firm did not respond to a request for comment ahead of publication.