GDP Requirements Audit Checklist
This GDP requirements audit checklist is designed to assess compliance with Good Distribution Practice in the storage and distribution of pharmaceutical and medical products. It covers the quality system, staff training and appointment of the Responsible Person; facility layout, hygiene and pest control; temperature mapping, monitoring and alarm management; equipment maintenance and calibration; computer systems and document management; supplier and customer qualification; goods receipt, storage, FIFO and inventory; complaints, returns and recall processes; transport vehicles, temperature-controlled shipping, delivery and hub management; deviation reporting; and controls for transporting products with special requirements.
Use this template with flowdit
- Customize this template or build your own
- Complete inspections using the mobile app
- Get reports and analyze your data
Start inspecting smarter — free for one user.
How to Use This Checklist
- Review the checklist section by section. The sections run from **Quality System** and **Personnel** through **Premises and Equipment**, **Outsourced Activities**, **Layout of Premises**, **Hygiene**, **Temperature and Environmental Control**, **Equipment**, **Computer Systems**, **Documentation**, **Standard Operating Procedures (SOPs)**, **Records**, and **Operations**, ending with **Supplier Qualification**, **Customer Qualification**, **Receipt of Goods**, **Storage**, **Delivery and Packaging**, and **Complaints, Returns and Recalls**. Work through them in the order that matches your operation, but do not skip a section because it looks familiar.
- Answer each of the 159 questions using the **Acceptable**, **Not Acceptable**, or **Insufficient Information** scale. Where the answer is not acceptable, or where you cannot find enough information to decide, treat that question as an open item rather than a closed one.
- Ground each answer in evidence: open the SOP, the log, the calibration certificate, the training record, or the temperature chart. The checklist asks you to confirm not only that a document exists but that it is current, approved, and used.
- Follow each negative or uncertain answer into an action. The quality system section calls for corrective and preventive action (CAPA) to correct and prevent deviations, change control covering changes to critical processes, and a management review system in operation. Record the action, the owner, and the date you will recheck.
- Repeat the exercise at a defined interval and before any significant change. The **Equipment** section expects re-validation before implementation and after any significant change or improvement, and a risk-based reassessment of requalification after repair or maintenance, so the audit cycle should match that rhythm.
Start inspecting smarter — free for one user.
Why GDP compliance matters
Good Distribution Practice (GDP) is the set of quality requirements that keeps medicinal products in the regulated supply chain from the manufacturer to the point of supply, so that the product a patient receives is the product that was made, stored, and transported under the conditions its licence assumes. A GDP requirement audit tests whether the wholesale distribution operation actually works to those requirements day to day: whether the quality system, the people, the premises, the equipment, the records, and the transport arrangements are in place and in use. The checklist addresses that body of work directly. It treats distribution as a chain of controlled steps, from supplier and customer qualification through receipt, storage, and delivery, and it asks for evidence at each step. Falsified medicinal products entering the supply chain are one of the risks this work is designed to prevent, and the checklist reflects that where it asks for personnel training on product identification and on preventing falsified products from entering the supply chain.
Quality system and the Responsible Person
The compliance case starts with governance. The checklist asks for a quality control log or equivalent documentation to be in place and maintained; a change control system covering changes to critical processes; corrective and preventive actions (CAPA) taken to correct and prevent deviations; and a management review system in operation. It also asks whether a Responsible Person (RP) has been appointed, whether their role is set out in a written job description, whether their qualifications meet the conditions of the legislation of the country in which they are located, and whether they fulfil the required obligations. Personnel questions extend this: an organization chart defining responsibilities and interrelationships, written job descriptions for key roles, GDP training for everyone involved in distribution, specialized training where required, and periodic documented assessment of the practical effectiveness of that training.
Premises, hygiene and environmental control
The physical operation determines much of the risk. The checklist asks whether unauthorized access is prevented; whether receipt and dispatch areas protect products from prevailing weather; whether segregated areas exist for suspected falsified products, returned, rejected, recalled or awaiting-disposal products, and medicinal products not intended for the EU market; whether hazardous products and products with fire or explosion risks have dedicated, suitably protected areas; and whether receiving, loading, storage, and staff rest or refreshment areas are adequately separated. Hygiene expectations include written and followed personnel hygiene procedures, prohibitions on bringing food, drink, smoking materials or personal medicinal products into storage areas, cleaning instructions and records, clean and waste-free facilities, and protection against insects, rodents, and other animals through a preventive pest control programme.
Temperature and equipment
Temperature-sensitive products fail quietly if environmental control is weak. The checklist asks for appropriate equipment and procedures to control environmental factors; temperature mapping of storage areas; monitoring equipment positioned on the basis of the mapping study; controls sufficient to hold all parts of the storage area within defined temperature, humidity, or light parameters; calibration and verification of monitoring equipment at defined intervals; suited alarm systems; appropriately set alarm levels; and regular alarm checks. Equipment questions cover planned preventive maintenance for key equipment, calibration against the standard procedure, kept records of repair, maintenance, and calibration, a documented risk assessment determining the scope of validation and qualification, re-validation before implementation and after significant change, documented verification of intended operation, and risk-based decisions on requalification after repair or maintenance.
Computer systems, documentation and records
Computerized systems carry much of the record of what happened to a product. The checklist asks for detailed written system descriptions covering principles, purposes, security, scope, main features, use, and interaction with other systems; entry or modification of data only by authorized persons; security against intentional or accidental damage by physical or electronic means; regular backups; and backed-up data stored securely for the period specified in national legislation, being at least five years. Documentation itself must be stored securely for the same period. SOPs must be reviewed regularly and kept up to date, approved, signed and dated by the appropriate authorized persons, checked for currency, with superseded versions archived and either not used or removed from the working environment. Records of any transaction relating to medicinal products received, supplied or brokered — including purchase and sales invoices and dispatch notes — must be kept, with defined minimum details.
Operations, suppliers and customers
The operational core of GDP sits in the flow of goods. The checklist covers supplier and customer qualification, receipt of goods, storage, and delivery and packaging. Storage questions include controls such as FIFO and inventory, while receipt and delivery questions test that goods are checked in and sent out under conditions that protect them. Complaints, returns, and recalls are covered as a distinct handling process, which is where deviations often first become visible to the distributor.
Outsourced activities
Distribution operations frequently rely on contracted parties. The checklist asks whether a contract is in force where premises are not operated directly by the wholesale distributor and fall under a wholesale distribution authorization. Where you rely on third parties for premises, transport, or other services, the agreement is the mechanism that keeps responsibility and quality oversight in place.
Judging compliance
The checklist uses a three-point scale: **Acceptable**, **Not Acceptable**, and **Insufficient Information**. When you mark a question as not acceptable, record what you saw and what should change. When you mark it as insufficient information, treat that as a gap in evidence rather than a pass, and go and find the record, the log, or the SOP that would settle the question. A GDP audit is only as useful as the actions it generates, so close the loop with the quality system — CAPA, change control, and management review — that the earlier sections of the checklist describe.
Frequently Asked Questions
Still managing operations with paper and Excel?
Digitize inspections, audits, SOPs, and corrective actions.
Book A Personal Demo
Resources Under The Same Category
GAP Audit Part 4 - Storage and Transportation Checklist
Utilize this comprehensive storage and transportation inspection tool to identif...
View template →
Site Investigation Report Template
A comprehensive site investigation report template designed for qualified enviro...
View template →
Ladder Inspection Checklist (HSE)
This checklist supports compliance with the Work at Height Regulations 2005 (WAH...
View template →
Environmental Site Audit Checklist
This comprehensive environmental site audit checklist empowers construction team...
View template →
LEED IEQ Inspection Checklist – Tower Construction
Structured Indoor Environmental Quality (IEQ) assessment framework designed to v...
View template →
OpenView Equipment Return Form
This equipment return form helps organizations recover and document company asse...
View template →Ready to simplify inspections and get your team moving faster?
Start free today and turn inspections into a clear, consistent digital workflow. Prefer a guided walkthrough? Book a demo and see how flowdit can fit your team.