SCOPE

This training program defines the complete knowledge and performance requirements for personnel within a logistics and transportation company to become certified internal auditors for Good Distribution Practices (GDP). The program integrates GDP requirements for warehousing and transportation, quality management principles, and the complete internal auditing process.

The participant learns both what GDP requires and how to plan, execute, report on, and close internal audits against those requirements.

Operational areas covered by this program include:

• Warehousing operations such as receipt, quarantine, temperature‑controlled storage for ambient, refrigerated, and frozen products, inventory management using FEFO, picking, dispatch, and returns handling.
• Transportation operations including active and passive temperature‑controlled road transport, vehicle qualification, shipping container selection and qualification, route profiling, loading and unloading procedures, temperature monitoring, and contingency planning.
• Quality systems including documentation, training, change control, CAPA, management review, risk management, supplier and customer qualification, complaint handling, recall readiness, and self‑inspection.
• Auditing practices, including audit programme management, audit planning, checklist design, evidence collection through interviews, observations, and document reviews, sampling techniques, working papers, non‑conformity classification, report writing, management notification, CAPA tracking, effectiveness verification, and audit closure.

The program is designed for internal auditing only and does not qualify individuals for third‑party certification audits or regulatory inspections.

OBJECTIVES

Upon completion of this self‑study program, the participant will be able to perform the following tasks.

• Interpret and apply all GDP requirements to warehousing and transportation operations.
• Understand and apply the seven quality management principles in the context of GDP logistics.
• Plan, manage, and execute internal audits in full accordance with auditing guidelines.
• Develop audit checklists, sampling plans, and audit protocols tailored to GDP risks.
• Collect objective evidence through interviews, observation, and document review.
• Identify and classify non‑conformities as major, minor, or observation with clear justification.
• Write non‑conformity reports that are factual, complete, and actionable.
• Prepare and distribute audit reports to appropriate management levels.
• Notify management of critical findings using escalation procedures.
• Track CAPA using a formal CAPA tracking log with status codes.
• Verify the effectiveness of corrective and preventive actions.
• Close an audit properly with a closure memo and management acknowledgment.
• Contribute audit results to management review and continual improvement.

TARGET AUDIENCE

This program is specifically designed for personnel working in logistics companies that operate both warehousing facilities for ambient, cold, and frozen products and temperature‑controlled trucking services. Typical roles include the following.

Quality Assurance Specialists and Managers who are responsible for maintaining GDP compliance and managing the internal audit programme.

Internal Auditors, both existing and prospective, who need formal training on GDP‑specific requirements and audit techniques.

Warehouse Operations Supervisors who must understand how their processes will be audited and how to prepare for inspections.

Transport Managers and Fleet Supervisors who require auditing skills for self‑inspection of vehicles and driver performance.

Logistics Coordinators who need to identify risks before they become non‑conformities and support audit activities.

Distribution Centre Managers who are accountable for site GDP compliance and must interpret audit findings to allocate resources.

Responsible Person or designee under GDP who has legal obligations for quality system implementation and must understand audit evidence requirements.

Customer Service and Returns Handlers who handle product complaints and returns need to know how to identify potential quality issues.

The prerequisites for enrolment include completion of a basic GDP awareness training of at least four hours or equivalent on‑the‑job experience. Participants should have at least six months of experience in pharmaceutical logistics. Basic computer skills using Excel and Word are also required.

CERTIFICATION

Learners who successfully complete the program will receive a dated, traceable certificate that provides verifiable proof of their achievement for professional records.