Hong Kong Regulations

PHARMACY AND POISONS REGULATIONS - REGULATION 34

Manufacturer's premises

(1) No pharmaceutical product shall be manufactured unless the premises and
the fittings and machinery therein used in the manufacturing and packaging of
such product are of such construction, materials and finish as to-

   (a)  permit the ready and efficient cleaning of all surfaces; and

   (b)  avoid the contamination of the product during manufacture and packing.

(2) All premises used in the manufacturing, testing, packing and despatch of
pharmaceutical products shall be-

   (a)  suitable for the purpose; and

   (b)  maintained in a clean and orderly condition.

(3) The temperature and humidity of the premises shall be controlled as
appropriate to the manufacture of the product or the process being carried out
therein.

(4) All parenteral products shall be manufactured and put into containers in
an enclosed area in which aseptic conditions can be maintained.

(5) The enclosed area referred to in paragraph (4) shall be separate from the
areas used for the manufacture and packing of other pharmaceutical products.