|138A||Title:||PHARMACY AND POISONS REGULATIONS||Gazette Number:|
|Regulation:||33||Heading:||Duties of manufacturers||Version Date:||30/06/1997|
(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.