National Health Act, 2003 (Act No. 61 of 2003)RegulationsRegulations relating to Human Stem CellsChapter 112. Quality and safety of stem cells |
A stem cell establishment shall take necessary measures to ensure that—
| (a) | an updated quality system based on the principle of good practice is put in place; |
| (b) | the quality system referred to in paragraph (a) includes at least the following documentation: |
| (i) | standard operating procedures (SOP); |
| (ii) | guidelines; |
| (iii) | training and reference manuals; |
| (iv) | reporting forms; |
| (v) | donor records; and |
| (vi) | information on the final destination of stem cells. |
| (c) | the documentation referred to in paragraphs (a) and (b) is available for inspection by the inspector of anatomy or an investigating officer. |