Section 39: Storage, records and samples

39. Storage, records and samples Every manufacturer shall— (a) provide facilities for storing his raw materials and products at the required temperature and relative degree of humidity to ensure that loss of potency and deterioration are reduced to a strict minimum; P8 – 21 [Issue 1] Pharmacy Act (b) keep at the factory, for a period of 3 years after the date of manufacture, a record of— (i) all products manufactured; (ii) the date of manufacture and the expiry date of products manufactured; (iii) the batch or lot number of raw materials and finished products; (iv) the raw materials used in the manufacture of a product; and (v) all analytical results in respect of each raw material and each finished product; and (c) keep at the factory, for a period of 5 years after the date of manufacture, representative samples of all raw materials and finished products. PART VIII – MISCELLANEOUS