GOOD DISTRIBUTION PRACTICE (GDP) IN THE PHARMACEUTICAL INDUSTRY
Course Introduction
This training provides a comprehensive understanding of Good Distribution Practice (GDP) principles to ensure the quality, safety, and integrity of pharmaceutical products throughout the supply chain. Participants will gain insights into regulatory requirements, warehouse and transport controls, cold chain management, risk-based practices, handling of returns and recalls, and audit readiness.
Objectives
- Understand GDP principles and regulatory obligations.
- Apply best practices for storage, transportation, and documentation.
- Manage risks, deviations, and CAPA in pharmaceutical distribution.
- Prepare effectively for audits and regulatory inspections.
Who Should Attend
- Warehouse & Logistics Personnel
- QA/QC Officers
- Supply Chain Managers
- Regulatory Compliance Officers
- Distributors & 3PL Providers
- Pharmacists & GDP Responsible Persons (RP)
Lessons Module
Day 1 – Fundamentals of GDP
- GDP principles, scope & global guidelines (EU, PIC/S, WHO).
- Regulatory agencies, NPRA licensing & GDP vs GMP.
- Warehouse layout, temperature mapping & cold chain setup.
- Roles of Responsible Person (RP), staff competence & hygiene.
- SOPs, traceability, deviation handling & documentation control.
Day 2 – Application & Compliance
- Receiving checks, FEFO, temperature control & route qualification.
- Complaint handling, product recalls & counterfeit management.
- Risk-based thinking, deviation management & CAPA effectiveness.
- Audit readiness: GDP checklist, inspection findings & compliance.
- Simulated recall & audit walkthrough, final assessment & feedback.
Benefits
- Gain in-depth understanding of GDP requirements.
- Improve compliance in storage, handling & distribution.
- Enhance risk management & deviation handling skills.
- Strengthen preparedness for audits & regulatory inspections.
- Ensure safe, effective and compliant pharmaceutical supply chain.
- 2 Days Programme
- 9:00am to 5:00pm
Training & Workshop Methodologies
- Interactive lectures & discussions
- GDP guideline summaries & SOP templates
- Case studies & group activities
- Internal audit checklist practice
- Simulated recall/audit exercise
