National Health Act, 2003 (Act No. 61 of 2003)RegulationsRegulations relating to Human Stem CellsChapter 116. Stem cell processing |
| (1) | A stem cell establishment shall include in its standard operating procedures and guidelines— |
| (a) | all processes that affect quality and safety and ensure that these are carried out under controlled conditions; |
| (b) | special provision for the handling of stem cells to be discarded, in order to prevent the contamination of other cells, processing environment or personnel. |
| (2) | Any modification to the process used in the preparation of stem cells shall also meet the criteria laid down in its standard operating procedures. |
| (3) | The stem cell establishment shall ensure that the equipment used, the working environment and process design, validation and control conditions are in accordance with its standard operating procedures. |