Inspection of medical products distributors against WHO Good Storage and Distribution Practices - 2022

A functioning pharmaceutical system is essential to provide access to appropriately used, quality- assured essential medical products including vaccine storage and distribution. It is a foundational element for health systems, a pre-requisite to universal health coverage, and a powerful means of promoting health equity”.

Medical product quality assurance is an essential part of the entire supply chain from the producers of active ingredients to health facility staff preparing prescriptions. At almost all levels in the supply chain, national and international pharmaceutical quality assurance standards are defined and applied. The national regulatory authorities (NRAs) are, along with other matters, responsible that those standards are adopted and implemented. It is their prerogative to authorize and inspect all pharmaceutical organizations.

Not all NRAs are familiar with the updated WHO Good Storage and Distribution Practices (GSDP) standards. They are not always familiar with the way to conduct an inspection, or to evaluate an organization’s corrective action and preventive action (CAPA) plan. Increased inspection knowledge and capacity with the NRAs would increase the number of patients that have access to quality medicines, including vaccines.

Course purpose
The purpose of this training is to provide personnel in NRAs with the skills to conduct GSDP inspections of wholesalers and distributors. The course will be based on WHO standards and will cover all medical products. Specific attention shall be given to the management of vaccines in the supply chain, in particular COVID-19 vaccines.

Learning objectives
The main objectives of the course are to:

• learn and appreciate GSDP standards and requirements
• develop GSDP inspection skills
• apply GSDP inspection skills in practical cases

Target audience
The target group for the course are staff of the national regulatory authorities or equivalent agencies, specifically staff that already conduct inspections or may conduct inspections in the future.

Learning strategies
The course is conducted on PAHO/WHO’s virtual educational platform, Virtual Campus for Public Health (VCPH). The course incorporates authentic learning principles and promotes a collaborative learning environment which will encourage sharing of resources and help establish a “community of practice” amongst the participants. The course tutor will be an GSDP auditing and training expert, and will be supported by an academic coordinator.

The course comprises interactive modules that will incorporate pre-recorded video presentations, readings, activities, quizzes, guides and tools. It will include weekly participation in discussion forums, short individual assignments, and interactive group Zoom video sessions facilitated by the course tutor, all based on practical scenarios encountered in GSDP inspections. The final assignment will comprise an authentically constructed case study. A pre/post-course test evaluation will be required to be completed at the beginning and end of the course.

Following completion of the course, where feasible, participants will be encouraged to organize to observe a GSDP inspection alongside a senior inspector.

Hours of commitment
It is estimated that the course will take 45 hours of time for each participant.

Course structure and schedule
The course is divided into 7 content modules over 11 weeks. Each module starts on a Wednesday and concludes on a Tuesday.

Module 0: Course Orientation and Introduction
Module 1: Global Quality Issues & Introduction to GSDP Guidelines
Module 2: Conducting GSDP Inspections
Module 3: General GSDP Quality System Requirements
Module 4: Receipt and Quality Control
Module 5: Storage and Warehousing
Module 6: Dispatch and Transport
Module 7: Cold Chain Management