Introduction

Good distribution practice (GDP) describes the minimum standards that a wholesale distributor must meet to ensure that the quality and integrity of medicines is maintained throughout the supply chain. GDP also applies to the sourcing, storage and transportation of active pharmaceutical ingredients and other ingredients used in the production of the medicines. This course helps aspiring participants to understand how GDP helps to continual improve organisational quality management system using its best practice. Participants learn the details of each clauses of the standard requirement to be able to apply within their organization.

Objective

To describe the concept overview of the GDP requirement.

To provide knowledge of fundamental of pharmaceutical GDP, the regulator(s) and related good practices.

To explain the importance of GDP in the management system.

To build awareness and encourage continual improvement within organization.

Content

Session 1:  Introduction

Describe overview pharmaceutical good distribution practice (GDP) including good storage practice (GSP).

Session 2:  Terms and Definitions

Describe relevant terms and definitions that normally use in the GDP system.

Session 3:  GDP documentation and policy

Explain development of GDP policy and procedure to comply with relevant requirement.

Session 4:  PIC/S and GDP requirement

Describe the GDP requirement clause by clause that implemented in conjunction with management system. Explain the general requirements of each PIC/S GDP guideline sections. Describe compliance and commercial impacts from poor distribution practices. Explain concept and awareness to improve effectiveness of the system.

Session 5:  Conclusion

Conclude requirement and explain step to implement the system.

*Exercise workshop will also be delivered in each key sessions*

Prerequisites

Basic knowledge in quality in supply chain will be more benefit. Experience in any industry will be more benefit.

Who should attend

This course is suitable for anyone in the industry who either already take a role concerns to distribute pharmaceutical medicines, services, materials, storage and so on or expect to do so as;

Managerial staff

Supervisory staff

Store/material/WIP/FG staff

Officer

Anyone who interested

Benefit

Upon successful completion of this training, participants will have knowledge of GDP standard requirement. Participants will know the process approach that can help organization streamline processess, which will lead to increased efficiency and productivity.