Medicines and Poisons (Poisons and Prohibited Substances) Regulation 2021
sec.20Batch manufacturing records
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sec.20 Batch manufacturing records
The holder of a manufacturing licence must keep a record of the following information for each batch of regulated poison manufactured under the licence— a unique identifier; details of materials used in the manufacture; the supplier of the materials for manufacture; the procedures and controls used in manufacturing; details of tests carried out during processing the batch; if a stability study is carried out to test the shelf life and appropriate storage conditions of the batch—details of the study. However, subsection (1) does not apply in relation to a batch of regulated poison that is a low-risk fluoroacetic acid bait manufactured for immediate use. s 20 amd 2023 SL No. 162 s 5 (sec.20-ssec.1) The holder of a manufacturing licence must keep a record of the following information for each batch of regulated poison manufactured under the licence— a unique identifier; details of materials used in the manufacture; the supplier of the materials for manufacture; the procedures and controls used in manufacturing; details of tests carried out during processing the batch; if a stability study is carried out to test the shelf life and appropriate storage conditions of the batch—details of the study. (sec.20-ssec.2) However, subsection (1) does not apply in relation to a batch of regulated poison that is a low-risk fluoroacetic acid bait manufactured for immediate use.
- (a) a unique identifier;
- (b) details of materials used in the manufacture;
- (c) the supplier of the materials for manufacture;
- (d) the procedures and controls used in manufacturing;
- (e) details of tests carried out during processing the batch;
- (f) if a stability study is carried out to test the shelf life and appropriate storage conditions of the batch—details of the study.