GMP violations at major Chinese drugmaker; Lupin, Sun recall products from US

By PharmaCompass

2019-01-17

Impressions: 423 Article

Qilu Tianhe Pharmaceutical, a company affiliated with the Qilu Pharmaceutical Group in China that produces APIs and finished dosage forms, was placed on Health Canada’s inspection tracker due to concerns over GMP observations made by a regulatory partner.

The firm employs over 1,500 people at its manufacturing site in Jinan City, Shandong in China. In August 2018, the company had received its first finished dosage form approval from the US FDA for the injectable combination of the antibiotics piperacillin and tazobactam.

Also placed on the Health Canada’s inspection tracker list is India’s Vital Laboratories Pvt Ltd (Plant I). The firm’s Plant II had received a warning letter from the FDA in 2017 in which the FDA had said it had cited “similar cGMP deviations at other facilities” in the firm’s network. Specifically, when FDA inspected Vital Laboratories Private Limited Plant-I (formerly known as Vital Healthcare Private Limited) in Vapi (Gujarat) in 2015, it was classified as unacceptable for drug manufacturing as a result of observations that were similar to those observed during Plant-II’s inspection.

With the FDA currently operating below full capacity due to the US government shutdown, it remains to be seen if the regulatory partner of Health Canada, which communicated the concerns, was the FDA or some other agency.

In other compliance news, a sterile injectable manufacturer in Slovakia — Unimed Pharma — failed an inspection conducted by the local Slovakian authorities as ‘critical’ deficiencies related to pharmaceutical quality management, cross-contamination management and quality assurance management were uncovered. As an outcome of the inspection, the authorities recommended restriction on the current GMP certificate issued to the site and stated that due to the nature of the non-compliance, prohibition of supplies is recommended, unless there are no alternative suppliers and there is a risk of shortage.

Indian generic manufacturers Lupin and Sun Pharma also encountered product quality issues as Lupin recalled 42 lots from the US market of Ceftriaxone for injection after the products were found to contain visual grey particulate matter in reconstituted vials. Sun Pharma also recalled three lots of Vecuronium Bromide for injection from the US market, as the product was found to contain particulate matter identified as glass.

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