1964_PHARMACY_AND_POISONS_REGULATIONS — Page 22

A 22

CAP. 138]

Pharmacy and Poisons Regulations

[1987 Ed.

[Subsidiary]

Records to be kept by manufacturers.

(b) avoid the contamination of the product during manufac-

ture 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.

35. (1) A manufacturer shall maintain adequate records in respect of each pharmaceutical product prepared by him, showing-

(a) the quantities of all substances used in the manufacture of

the product;

(b) the quantity of the product manufactured;

(c) the name and the address of the person to whom the phar-

maceutical product was sold or supplied;

(d) the nature and results of tests made on each lot or batch of

raw or bulk materials used in the product;

(e) the nature and results of tests made on each batch of

finished product;

(ƒ) any complaints received relating to the product and the

action taken thereon by him; and

L.N. 228/75.

(g)

L.N. 137/78.

Registration of pharmaceutical products and substances.

L.N. 137/78. L.N. 369/80.

L.N. 85/87.

the nature and result of any tests made on the samples retained.

(2) The records required to be maintained by paragraph (1) shall be completed within 72 hours from the time the process or test was carried out or the transaction took place.

PART VIII

REGISTRATION OF PHARMACEUTICAL PRODUCTS AND SUBSTANCES

36. (1) Subject to paragraph (1A), no person shall sell, offer for sale or distribute or possess for the purposes of sale, distribution or other use any pharmaceutical product or substance unless the product or substance is registered with the Board-