WHO issues Notice of Concern to Svizera Labs PVt. Limited facility in India

WHO has recently issued a Notice of Concern (NOC) to Svizera labs Private Limited Indian facility.  Svizera labs Private limited is a subsidiary of Maneesh Pharmaceuticals and manufactures a number of anti tuberculosis drugs for Svizera Europe. Following an inspection done by WHO prequalification team warning letter issued to the facility. Warning letter was issued due to good manufacturing practices violations.

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. Also granulation equipment was found to be scratched, chipped and rusted in parts while rubber seals had many pieces missing.

Other critical deviations observed 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.