Section 38: Quality control

38. Quality control Every manufacturer shall— (a) provide on his premises adequate facilities for quality control of raw materials, finished products and stocks; (b) ensure that raw materials used in the manufacture of a pharmaceutical product are of the required degree of purity and fit for pharmaceutical use; (c) ensure that in pharmaceutical products requiring aseptic technique— (i) the factors influencing their contamination are under control; (ii) the aseptic precautions are fulfilled; and (iii) the finished products comply with tests for pyrogens or for freedom from undue toxicity or for sterility.