14 Apr 2009
The Director of Health, Dr P Y Lam, today (April 14) visited local pharmaceutical company Europharm to see the remedial measures taken by the company following the detection last month of drug contamination during the production process.
Also on the visit were Head of Department of Microbiology, the University of Hong Kong Professor K Y Yuen and the Deputy Director of Health, Dr Gloria Tam.
Dr Lam said that having inspected Europharm on several occasions, the department's pharmaceutical inspectors formed the opinion that the company's hard and soft ware for the production and quality control of drugs were satisfactory and up to Good Manufacturing Practices standards.
He noted that as crucial factors leading to the mishap had been addressed, Europharm was ready to resume production any time.
"We were particularly concerned about the company's governance and the matching of its capacity and production flow.
"However, we now note that the professional management of Europharm is now reformed, to be headed by a pharmacist with 13 years of relevant experience.
"The company's standard operating procedures have also been revised, placing limit on intermediate products' critical duration," Dr Lam said.
The company would also introduce microbiological analysis on raw materials, intermediate and finished non-sterile products as well as enhancing environmental monitoring.
"The Department of Health's Pharmaceutical Service will closely monitor the operation of Europharm to ensure all remedial measures are fully executed."
Europharm voluntarily stopped all manufacturing operations on March 6 to facilitate the Department of Health's investigations into the contamination of some batches of allopurinol tablets (brand name :Purinol) manufactured by the company. The drug concerned had been prescribed to some patients in public hospitals who were later found to have suffered from invasive gastrointestinal mucormycosis.
The company subsequently conducted thorough cleansing of its production lines and comprehensively reviewed its production process with a view to introducing targeted remedial measures.
It also invited an expert from Australia to identify areas for improvement and to make recommendations in its manufacturing activities.