Director of Health Dr PY Lam today inspected local pharmaceutical company Europharm and declared it ready to resume production.
He checked the remedial measures taken by the company following the detection last month of drug contamination during the production process.
He was accompanied by Deputy Director of Health Dr Gloria Tam and University of Hong Kong Department of Microbiology Head Professor KY Yuen. They agreed the company's hardware and software for the production and quality control of drugs was satisfactory and up to good manufacturing practice standards.
"We were particularly concerned about the company's governance and the matching of its capacity and production flow," Dr Lam said. "We note the professional management of Europharm is now reformed, to be headed by a pharmacist with 13 years of experience. The company's standard operating procedures have also been revised."
The company will introduce microbiological analysis on raw materials, intermediate and finished non-sterile products, and enhance environmental monitoring, based on the recommendations of the Department of Health's Expert Group on Microbiological Hazards in Drug Manufacturing.
Europharm stopped all manufacturing operations on March 6 so the Department of Health could investigate the contamination of the allopurinol tablets, Purinol, it manufactured.
"The Department of Health's Pharmaceutical Service will closely monitor the operation of Europharm to ensure all remedial measures are fully executed," Dr Lam said.
The Hospital Authority will ask Europharm to provide details of its upcoming improvement measures before evaluating the position of its existing contracts with the company. Europharm has 13 supply contracts with the authority which have been shelved since the allopurinol incident.
Meanwhile, the authority is seeking legal advice on the supply of allopurinol by Europharm and will further pursue liability issues.
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