GDP Audits: Preparing for AIFA Inspections and the Most Common Non-Contacts

GDP Inspection as a "Moment of Truth"

For a pharmaceutical distributor, an inspection by regulatory authorities (in Italy, typically AIFA, Regions, or NAS) is the "moment of truth." It formally verifies that the GDP Quality System isn't just there on paper, but is effectively implemented to protect medicines and patients. For the GDP Responsible Person (RP), the inspection is a direct verification of their responsibilities.

Being "Audit-Ready" doesn't mean frantically preparing the week before, but rather maintaining a consistent state of compliance. However, targeted preparation is essential. This article explores what auditors look for, the most common non-conformities (NCs), and how PR can ensure the company is ready to respond.

What are the inspectors looking for (AIFA, NAS, EMA)?

GDP inspectors base their checks on national legislation (Legislative Decree 219/06) and European Guidelines (2013/C 343/01). Their objective is to verify that a system exists to prevent risks.

Key areas of investigation during a GDP inspection include:

1. Quality Management System (QMS): Are there procedures (SOPs) for all critical activities? Are deviations, CAPAs and changes managed?
2. Responsible Person: Is the RP formally appointed, has the legal requirements (degree) and is actually involved in decisions (e.g. approval of returns)?
3. Premises and Equipment: Are warehouses suitable, clean, secure, and thermally mapped? Are cold storage rooms qualified and monitored with alarms?
4. Operations Management: How are returns handled? Are there clear segregation areas (expired, broken, quarantined, counterfeit)?
5. Supply Chain Qualification: Can the company demonstrate that it has qualified suppliers (EudraGMDP control), customers and, above all, transporters (with Quality Agreement)?
6. Traceability: In the event of a recall, how long does it take for the company to tell who sold a specific batch?

The Most Common Non-Conformities (NCs) in GDP Audits

Knowing the mistakes of others is the best way to prevent your own. GDP inspections often reveal recurring findings. The RP must actively monitor these areas:

• NC Criticism: Shortcomings in the Cold Chain
• Typical finding: "Lack of qualification tests (mapping) of refrigerated transport vehicles" or "Warehouse temperature monitoring system not continuous (manual readings only) and without alarms".
• Risk: Thermolabile medicines (vaccines, insulin) exposed to incorrect temperatures, with loss of efficacy.
• Corrective Action (CR): Implement 24/7 monitoring with alarms and perform thermal mapping studies (validation) of warehouses and vehicles.
• NC Serious: Non-Compliant Returns Management
• Typical finding: "Products returned by customers are being returned to saleable stock without documented assessment and formal approval by the Responsible Person."
• Risk: Re-introduction into the supply chain of a potentially poorly stored or counterfeit drug.
• Corrective Action (CAP): Establish a returns management SOP that includes physical segregation and a formal evaluation form that the CAP must sign before authorizing reinstatement.
• NC Serious: Failure to Qualify Suppliers and Transporters
• Typical findings: "The company purchases from suppliers without verifying their authorization on the EudraGMDP database" or "There is no contract (Quality Agreement) defining GDP responsibilities with third-party transporters."
• Risk: Purchase from illegal sources (counterfeits) or entrusting transport to unsuitable couriers.
• Corrective Action (CR): Create an approved supplier list (ASL) based on document checks and enter into Quality Agreements with all logistics partners.
• NC Municipality: Lacking Documentation and Training
• Typical finding: "Missing or outdated SOPs" or "Lack of evidence of GDP training for warehouse staff."
• Risk: Operations performed incorrectly or non-standardized due to lack of instructions or awareness.
• Corrective Action (CR): Plan an annual training program and periodically review all SOPs.

Audit Readiness: The RP Preparation Checklist

A forward-thinking RP uses internal audits (self-inspections) as its primary preparation tool. Self-inspections must be rigorous, documented, and generate CAPAs.

Here is an essential checklist for the RP before an official inspection (based on the Operational Appendix of the PDF):

1. Quality System Area (QMS):

• [ ] Is there an updated Quality Manual?
• [ ] Is the appointment of the RP (with CV and degree) formalized and communicated to the authority?
• [ ] Is there a register of Deviations and CAPAs? Are they all closed or under action plan?
• [ ] Is there a Change Control registry?
• [ ] Is the latest Self-Inspection report available with the related CAPAs?

2. Personal and Training Area:

• [ ] Are there Job Descriptions that define GDP tasks?
• [ ] Is there an annual GDP training plan?
• [ ] Are training records (signatures, topics) available to all staff (including drivers, if internal)?

3. Premises and Equipment Area:

• [ ] Is the warehouse floor plan up to date?
• [ ] Are the areas clean, tidy and well identified (e.g. "Quarantine", "Returns", "Expired")?
• [ ] Are the Thermal Mapping reports (warehouse and refrigerator) available and valid?
• [ ] Are temperature records (last 12 months) complete and show hike management?
• [ ] Are temperature sensor calibration certificates valid?
• [ ] Are there any tests of temperature alarms?

4. Operations and Logistics Area:

• [ ] Are the suppliers randomly qualified (check EudraGMDP)?
• [ ] Are customers allowed to sample?
• [ ] Are the Quality Agreements signed with the carriers available?
• [ ] Are cold chain validation reports available?
• [ ] Has the Recall procedure been tested (simulated) in the last year?
• [ ] Do the Returns records show formal RP approval for the reinstatement?

Typical Error vs. Corrective Action (Case Study)

• Error (Finding): Case 6: Suspected illegal parallel market. AIFA inspects a distributor and discovers massive, unreported sales of a drug in short supply in Italy to a foreign wholesaler.
• Implications: Violation of public service obligations and shortage regulations. Fines, license suspension, and removal of the RP.
• Lesson (Corrective Action): The RP must never give in to commercial pressure that violates regulations. The RP has a legal responsibility to ensure compliance with public service obligations and to notify exports of deficient drugs, including by challenging commercial management.

Conclusion

Passing a GDP audit requires transparency, organization, and a truly effective quality system. The Responsible Person is the orchestrator: by using self-inspections, rigorously managing documentation, and training staff, they can transform the inspection from a feared event to an opportunity to demonstrate the company's operational excellence.

Keep your company audit-ready and protect your distribution license. Discover all the operational tools in the " Complete Guide to Good Pharmaceutical Distribution " on GuideGxP.com.