Our highly experienced, trained, and competent team of specialists conducts independent, internationally aligned GSDP audits to verify that your local partners maintain the required systems, infrastructure, and documentation and operate at the highest standards of pharmaceutical storage and distribution.. We assess 14 critical areas, from warehouse conditions to cold chain management, with reference to their global partner system and the current WHO’s Good Storage and Distribution Practices (GSDP) standards. Our audits empower global stakeholders of pharmaceutical companies and organizations with the assurance that the GSDP systems of their local pharmaceutical partner are sufficient to meet their operational needs and the current regulatory standards.
Our Approach to GSDP Auditing
As an on-the-ground extension of your GSDP Auditing team, we conduct audits on your behalf, using your established audit program or the Qual Med Yemen process, whichever works best for your needs. Our GSDP experts have experience auditing systems against applicable regulatory and industry standards. Our experts work with you and your local partner to apply the correct standards based on your needs, the activities or services provided, and the stage of your project. During our evaluations, we can identify areas for improvement or potential compliance risks. We assess a wide range of GSDP activities.
| GSDP Q.A. CRITERIA | |
| Pillar A | General quality assurance requirements |
| Pillar B | Quality control & reception |
| Pillar C | Storage & handling specific products |
| Pillar D | Dispatch & Transport |
| GSDP Q.A. CRITERIA | |
| 1 | QA system |
| 2 | Documentation system |
| 3 | Computerised systems |
| 4 | Human resources |
| 5 | Self inspection |
| 6 | Control at reception |
| 7 | Quality control |
| 8 | Warehouse organisation |
| 9 | Physical storage conditions |
| 10 | Management of the cold chain |
| 11 | Stock Control |
| 12 | Handling non conformity products |
| 13 | Dispatch |
| 14 | Transport |

