Singapore legislation
Regulation 22
Regulation 22
Duty to maintain records of manufacture
Subregulation 1
A manufacturer of an active ingredient (other than an active ingredient mentioned in regulation 9(a) or (b)) must maintain records of —
the information relating to the active ingredient and its manufacture or assembly as the Authority may specify on the Authority’s website or, if the manufacturer is the holder of a manufacturer’s licence, in the manufacturer’s licence; and
the manufacture of each batch of the active ingredient and of the tests carried out on each such batch, in the manner specified on the Authority’s website or in the relevant licence issued by the Authority (if applicable).
Subregulation 2
The manufacturer must maintain for any active ingredient the records mentioned in paragraph (1) for the longer of the following periods:
one year after the expiry date of the active ingredient;
5 years after the date of manufacture of the active ingredient.