【法规名称】
【法规编号】 82241 什么是编号？
【正 文】
第9页 CAP 138A PHARMACY AND POISONS REGULATIONS
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[接上页] (c) the name and address of the manufacturer; and (d) the number of the certificate of drug/product registration or the provisional certificate of drug/product registration of the pharmaceutical product issued by the Board.(2) For the purposes of paragraph (1)- (a) the expression "appropriate designation" (适当称号), in relation to a substance, constituent or ingredient, means- (i) in the case of a poison included in the Poisons List, the name with which the container of the poison is for the time being required to be labelled in accordance with regulation 13; (ii) in the case where a substance, constituent or ingredient is not a poison and is described in any of the monographs contained in the edition of the British pharmacopoeia, the British Pharmaceutical Codex or the British Veterinary Codex which was last published before the date on which the article was sold or supplied, the description set out at the head of that monograph; and (iii) in any other case the accepted scientific name or the name descriptive of the true nature and origin of the substance, constituent or ingredient;(b) the expression "appropriate quantitative particulars" (适当数量详情), in relation to the active constituent or ingredient of a pharmaceutical product, means- (i) the percentage or quantity of that constituent or ingredient contained in the pharmaceutical product sold or supplied; or (ii) in the case of a pharmaceutical product which is in pill, capsule, tablet or similar article, either the percentage or quantity of the substance or substances comprising or forming part of the pills, capsules, tablets or similar articles, or the quantity of each constituent or ingredient in each pill, capsule, tablet or article.(3) For the purposes of paragraph (1) the container to be labelled shall, where the pharmaceutical product is packed by the manufacturer in more than one container, be the container which is likely to be sold or distributed to the ultimate user of the product. (4) In the case of a pharmaceutical product intended for export it shall be a sufficient compliance with this regulation if the container of the product is labelled with the following particulars- (a) the name and address of the manufacturer; and (b) such other details as the importing country may require. (L.N. 137 of 1978) Cap 138A reg 32 Manufacturing workers not to infect products A manufacturer shall take adequate steps to ensure that every person engaged in the manufacturing or packing of pharmaceutical products does not contaminate or infect such products. Cap 138A reg 33 Duties of manufacturers (1) Subject to paragraph (1A), a manufacturer shall test each lot or batch of raw or bulk material intended to be used in the manufacture of pharmaceutical products to ensure identity and purity. (1A) Raw or bulk material the identity and purity of which the manufacturer thereof has certified by a certificate of analysis does not require a test by a manufacturer under paragraph (1). (2) A manufacturer shall test each batch of pharmaceutical products in a finished form to ensure identity and potency. (3) Every parenteral product shall be manufactured in accordance with the method of preparation of injections laid down by the British Pharmacopoeia or other Pharmacopoeia with which the particular product is intended to comply. (4) A manufacturer shall maintain a control sample of each batch of finished products under conditions of storage suitable to that product for a period of not less than the normal shelf-life of the product or 2 years after the last transaction in that batch of products whichever is the shorter period. (5) A manufacturer shall set up and maintain a system of control that will enable the rapid and, so far as practicable, complete recall of any lot or batch of a pharmaceutical substance or product from sale to the public in the event of the pharmaceutical substance or product being found to be dangerous or injurious to health. (L.N. 137 of 1978) Cap 138A reg 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. |
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