Good Storage and Distribution Practice (GS&DP): Drug Industry

Course Code: BETCO/004AR

Description: This training session will detail best practices for storage and distribution of pharmaceutical medicines. Participants will be offered a comprehensive understanding of Good Storage & Distribution Practice (GS&DP) in relation to the local (SFDA) & International Regulatory Authorities including EMEA & FDA. This course is important because: a- Storage is a critical parameter in maintaining the quality, safety and efficacy of a drug product. b- Stability of the Product. c- Product must be stored in accordance with the requirements of its registration authorization

Learning Outcomes: The objective of this course is to provide the trainees with a comprehensive understanding of the Good Storage & Distribution Practice (GS&DP) definitions and requirements. On the completion of this training, participants will: 

  • Be familiar with SFDA Good Storage & Destruction Practice Guidelines.
  • Explain the role of the warehouse 
  • List the GMP procedures needed in the warehouse to control incoming goods 
  • Identify the GMP requirements for handling starting materials and finished products in the warehouse 
  • Recognize the GMP issues surrounding storage & dispatch of finished products to the marketplace 
  • Recognize how returns are handled by the company 
  • Identify the different documentation needed in the warehouse 
  • Identify the controls necessary to ensure compliance with GS&DP

 

Target Audience:  

  • Warehouse and distribution staff and management 
  • Transportation Staff 
  • Quality Assurance staff and management 
  • Materials department staff and management 
  • Purchasing, planning, inventory management staff 
  • Logistics and customer services personnel 
  • Air and Sea Cargo Handling & Storage staff and management 


Methodology: 
PowerPoint Presentation and Case Studies Exercises

Course curriculum

  • 1

    GS & DP: Drug Industry

    • Lesson 1: GS&DP Introduction

    • Lesson 2: GS&DP Definitions

    • Lesson 3A: SFDA GS&DP Guidelines

    • Lesson 3B: SFDA GS&DP Guidelines

    • Lesson 4: GS&DP Q&A

    • Lesson 5A: Store Temperature Mapping

    • Lesson 5B: Storage Temperature Mapping

    • Course Assessment

    • Course Evaluation