GDP Audit Checklist

This GDP Audit Checklist can be used by wholesale distributors of pharmaceutical products to assess and ensure compliance with Good Distribution Practices.

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Warehouse
GDP Audit Checklist

GDP Audit Checklist

Transportation

General

Change Control

Deviation Management

Management Of Outsourced Activities

Management Review And Monitoring

Quality Risk Management

Personnel

Premises And Equipment

Documentation

Operations

Complaints, Returns, Suspected Falsified Medicinal Products And Medicinal Product Recalls

Outsourced Activities

Self-Inspections

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Checklist by GoAudits.com – Please note that this checklist is intended as an example. We do not guarantee compliance with the laws applicable to your territory or industry. You should seek professional advice to determine how this checklist should be adapted to your workplace or jurisdiction.

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GDP Audit Checklist

This GDP Audit Checklist can be used by wholesale distributors of pharmaceutical products to assess and ensure compliance with Good Distribution Practices.

1. Does the company outsource transportation services or does the company transport in company-owned vehicles?

2. Are vehicles cleaned and fit for purpose?

3. Is temperature monitoring data for selected shipments provided?

4. What is the organization's approach to planning transportation?

5. Are drivers trained in GDP, do they have access to relevant written procedures?

6. How are storage conditions ensured during transportation?

7. What happens if storage conditions are not maintained during transportation?

8. How are storage conditions maintained during temporary storage in hubs or reloading during transportation?

9. What kind of additional control systems does the company have in place for the delivery of these products?

10. Are there protocols or policies in place to address the occurrence of theft?

11. Are narcotics or other products at high risk for theft appropriately handled?

12. Are highly toxic or radioactive products appropriately handled?

13. Are temperature-sensitive products appropriately handled?

14. Who owns the vehicles used?

15. How is equipment maintained and calibrated?

16. How are the necessary storage conditions achieved within the vehicles?

17. Has appropriate temperature mapping of each vehicle’s controlled storage area been performed?

18. How is packaging chosen for the transportation of medicines?

19. How are cool packs handled and packed?

20. What information is part of transport labeling?

21. Has each packaging configuration been appropriately qualified?

22. Are all packages correctly labeled with all the relevant information, e.g., identity, source, handling, temperature, and storage conditions?

23. Have temperature-controlled containers or thermal packaging been fully qualified?

24. Are narcotics or other products at high risk for theft handled?

25. Are highly toxic or radioactive products handled?

26. Are temperature-sensitive products handled?

27. Are appropriate procedures available for handling high-risk narcotics, highly toxic, or radioactive products?

28. Are procedures available for handling temperature-sensitive products?

1. Is the content of the license/application accurate with the following: Procurement Holding/Storage Supply Export Contracted operation

2. Is the content of the license/application accurate with any medicines the company may handle in line with national legislative definition?

3. Have deficiencies from previous inspections been appropriately addressed in line with corrective/preventative actions (CAPAs) outlined in the company's response to previous inspection findings?

4. Are changes to operations that may affect the risk profile of the organization e.g. premises, equipment, computerized systems, subcontracted activities, key personnel, and products handled?

5. Were changes managed in accordance with appropriate change control procedures?

1. Is there an appropriate procedure available?

2. Is there a log of change requests raised in the period since the last inspection?

3. Is there a classification in accordance with quality risk management principles?

4. Were the changes notified and approved by the relevant authorities if it was required?

1. Is an appropriate procedure defining deviation management available?

2. Is there a record of deviations raised in the period since the last inspection?

3. Is there a classification in accordance with quality risk management principles and appropriately documented?

4. Have appropriate CAPAs been taken to correct and prevent deviations?

1. Are any GDP-related activities outsourced?

2. Have the principles of quality risk management been incorporated?

3. How does the company initially approve a service provider?

4. Is there a system for monitoring and reviewing the performance of contract acceptors?

1. Is there an appropriate procedure available?

2. Is the outcome of the review documented and communicated internally?

1. Is there an appropriate procedure available?

2. Have the principles been incorporated into the company’s management of change, deviations, complaints, and outsourced activities?

3. Which processes identify risks to the quality of the product?

1. Is an organization chart available?

2. Is the number of persons involved in wholesaling operations adequate or appropriate for the GDP operations?

3. Are job descriptions available for key personnel?

4. Does the job description reflect the key responsibilities?

5. Have relevant personnel received initial and continuous GDP training?

6. Are training records available?

7. Are assessments conducted and documented?

8. Is there a program for regular periodic training in GDP?

9. Does the training program include aspects related to falsified medicinal products?

10. Is specific training provided related to temperature-sensitive products and controlled drugs?

11. Have personnel received training in SOPs relevant to their role?

12. Are assessments conducted and documented?

13. Is training provided in updated revisions to SOPs?

14. Is specific training provided pertaining to medicines handled, e.g. related to temperature-sensitive, hazardous, radioactive products and controlled drugs?

15. Is there an appropriate procedure in place covering health, hygiene, and clothing requirements?

1. Is there adequate lighting and ventilation in the storage areas?

2. Is access to storage areas appropriately restricted to authorized personnel?

3. Are rejected products, returned products, expired products, and recalled products physically segregated?

4. Do procedures require falsified medicinal products to be physically segregated?

5. Are products not authorized for the approved market physically segregated, even in cold storage areas?

6. Are these areas clearly identified and demarcated?

7. Are controlled drugs stored in accordance with national legislation?

8. Are radioactive materials and other hazardous products stored in accordance with national legislation?

9. Are the procedures and controls for the management of inbound and outbound goods appropriate?

10. Are radioactive materials and other hazardous products, as well as products presenting a special safety risk of fire or explosion, stored in accordance with national legislation?

11. Do receiving and dispatch bays protect products from prevailing weather conditions?

12. Is there sufficient space/capacity to allow safe storage and handling of products?

13. Are the storage areas appropriately maintained?