(a)
(b)
(c)
29
how it will monitor the implementation of the GMP by local drugs manufacturers;
of the present standards adopted by the relevant government departments in the manufacture of drugs, and whether the Department of Health and the Hospital Authority have any plan to adopt the GMP; and
whether the Central Pharmaceutics Manufactory, which will be completed shortly in Chai Wan, will be equipped with the necessary facilities and apparatus for implementing the GMP; and what other measures have been taken by the Government to complement the implementation of the GMP?
Reply:
(a)
(b)
(c)
Implementation of GMP by local drug manufacturers will be monitored by the Forensic Pharmacy Division of the Department of Health. "Hong Kong Good Manufacturing Practices Guidelines for Pharmaceutical Products 1995" and an "Implementation Programme of Good Manufacturing Practices in Hong Kong" were issued to all local pharmaceutical manufacturers in December 1995, providing details of the stages of implementation of GMP as stipulated by the Pharmacy & Poisons Board. Briefing sessions have been organised for the industry and the implementation of GMP has been imposed as one of the conditions for renewal of licence. Authorised pharmacist inspectors will make regular inspections of manufacturers to ensure that the requirements are complied with.
The manufacture of pharmaceutical products by the Department of Health conforms with the requirements, including GMP, stipulated by the Pharmacy & Poisons Board. The pharmacies of HA hospitals are mainly involved in compounding and mixing of pharmaceuticals, and sterile preparations are mostly purchased in bulk. Requirements as stipulated in the Pharmacy and Poisons Regulations and the standards in the British Pharmacopoeia are strictly adhered to.
H
The Central Pharmaceutical Manufactory in Chai Wan has been designed and is being constructed and equipped with the necessary facilities for implementing GMP. To facilitate such implementation, training, including overseas attachments, has been provided to staff on the principles and practice of GMP,
End