A Notice of Concern (NOC) is implemented by the World Health Organisation (WHO) to facilities it deems has violated Good Manufacturing Practices (GMP), and following an inspection in June, the agency’s Prequalification Team has this week issued such a warning to a site in Navi, Mumbai.
The facility is run by Svizera Labs Private Limited – a subsidiary of Maneesh Pharmaceuticals – and manufactures a number of anti-tuberculosis drugs for Svizera Europe which, despite the namesake, is an independent supplier and distributor of infectious disease treatments to the WHO.
According to the Notice, the firm failed to provide adequate controls to stop the contamination of products, with inspectors observing uneven floor, crumbling walls, and black mould inside a drain which also held stagnant water.
Furthermore, granulation equipment was found to be scratched, chipped and rusted in parts while the rubber seals had many pieces missing.
Other critical deviations from the WHO GMP standards observed at the site, included: issues around the integrity of dissolution test results and sample data, failure in conducting stability tests in line with protocols, and failures in maintaining equipment use records.
The pre-qualified products made at the Mumbai facility are supplied to Svizera Europe, where final batch release is carried out.
We spoke to Anuschka Ploos van Amstel, Quality manager at The Netherlands-based company, who said Svizera Europe is disputing the WHO’s findings.
“We disagree with the content of the report and the decision of WHO/PQ to publish such an NOC,” she told in-Pharmatechnologist.com.
“Based on the initial report … our QP initiated a full WHO GMP audit by an independent company - SGS Chennai - with a focus on the observations made by WHO/PQ whereas the conclusion is that the said plant is fully compliant with WHO GMP.”
At this stage, the NOC will not affect current pre-qualified products, van Amstel confirmed, though the firm cannot submit new dossiers to pre-qualification until the warning has been lifted.