Good Documentation Practice (GDocP): Drug Industry

Course Code: BETCO/005AR

Description: This training session will detail best practices for documentation, list types of documents, and highlight key documentation requirements. Documentation is essential where Saudi Food & Drug Authority (SFDA) impose a special recordkeeping burden. Good Documentation Practices (GDocP) are a set of activities that enable you to record your data and hand-written entries in a legible, traceable and reproducible manner. Documentation that is used in support of Manufacturing, Quality Control, Quality Assurance & Logistics process should adhere to GDocP.

Learning Outcomes: The objective of this course is to provide the trainees with a comprehensive understanding of the Good Documentation Practice (GDocP) definition and requirements. On the completion of this training, participants will: 

  • Understand Saudi Food & Drug Authority (SFDA) regulations pertaining to documentation.
  • Know what is documentation?
  • Know what is documentation system?
  • Know what are the types of documents?
  • Know what is Good Documentation Practices?
  • Complete any paper based document with complete confidence
  • Be able to produce all documents in a consistent, understandable and traceable manner. 
  • Review some violations examples of GDocP and some US FDA Waning Letters pertained to documentation errors and lack of GDocP.


Target Audience: Production staff at all levels. Quality Control and Quality Assurance staff at all levels. Regulatory and Compliance staff at all levels. Maintenance & Engineering staff at all levels. Logistic staff at all levels. Supply Chain staff at all levels.

Methodology:
PowerPoint Presentation and Case Studies Exercises

Course curriculum

  • 1

    GDocP: Drug Industry

    • Lesson 1: Introduction

    • Lesson 2: Guidelines Part 1

    • Lesson 2: Guidelines Part 2

    • Lesson 3: Guidelines

    • Lesson 4: Practical Violation Examples

    • Lesson 5: US FDA Warning Letters

    • Course Assessment

    • Course Evaluation