In December 2023, HSA updated the following Good Distribution Practice (GDP) guides:
– GUIDANCE NOTES ON GOOD DISTRIBUTION PRACTICE https://www.hsa.gov.sg/docs/default-source/hprg-ald/guide-mqa-013.pdf
– GUIDANCE NOTES ON PREPARATION OF A SITE MASTER FILE FOR GOOD DISTRIBUTION PRACTICE CERTIFICATION https://www.hsa.gov.sg/docs/default-source/hprg-ald/guide-mqa-022.pdf
HSA has defined GDP principle as “The licensee has the ultimate responsibility to ensure an effective quality management system (QMS) is in place to manage the GDP activities.
The system should be fully documented, monitored for effectiveness, and supported by competent personnel and suitable facilities. The QMS should also extend to outsourced activities. Where appropriate, risk-based approach should be applied in the implementation of the QMS.”, and the guideline updates includes emphasis and detailed alignment with this defined principle.