Natural Health Products Regulations

53 Every manufacturer who sells a natural health product shall maintain the following records at the site at which the natural health product is manufactured:

• (a) the master production document for the natural health product;

• (b) a list of all ingredients contained in each lot or batch of the natural health product;

• (c) records of any testing conducted in respect of a lot or batch of raw material used in the manufacture of the natural health product;

• (d) records of any testing conducted by or for the manufacturer in respect of a lot or batch of the natural health product;

• (e) a copy of the specifications for each natural health product that is being manufactured at the site;

• (f) records demonstrating that each lot or batch of the natural health product was manufactured in accordance with the requirements of this Part;

• (g) a record of each determination made by the manufacturer in accordance with section 52 and the information that supports that determination;

• (h) records containing sufficient information to enable the recall of every lot or batch of the natural health product that has been made available for sale;

• (i) a list of all natural health products that are being manufactured at the site; and

• (j) a copy of the sanitation program in use at the site.