1987 Ed.]
Pharmacy and Poisons Regulations
[CAP. 138
A 21
[Subsidiary]
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.
32. 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.
33. (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.
34. (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
L.N. 137/78.
Manufacturing workers not to infect products.
Duties of manufacturers. L.N. 137/78.
Manufacturer's premises.
1
1987 Ed.]
Pharmacy and Poisons Regulations
[CAP. 138
A 21
[Subsidiary]
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.
32. A manufacturer shall take adequate steps to ensure that every person engaged in the manufacturing or packing of phar- maceutical products does not contaminate or infect such products.
33. (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.
(IA) 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 accord- ance 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.
34. (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 con- struction, materials and finish as to-
(a) permit the ready and efficient cleaning of all surfaces; and
L.N. 137/78.
Manufacturing workers not to infect products.
Duties of manufacturers. L.N. 137/78.
Manufacturer's premises.
1
]
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