What are GDP Auditing & Inspections?

Ensuring Good Distribution Practice (GDP) compliance.

GDP Auditing & Inspections are regulatory requirements that play a key role in verifying and guaranteeing that Authorized Wholesalers and Distributors (WDAs) of human or veterinary medicinal products follow GDP guidelines.

These entities must maintain and demonstrate fully documented and organised proof of compliance through an effective quality management system. This must have appropriate controls for all collaborators and service providers in the distribution chain, including retailers, logistics providers, storage facilities, packagers, and more.

An authority inspection can be initiated at any given time, and the self-auditing process establishes a continuous trail of compliance, ensuring preparedness for inspections whilst safeguarding the safety of end users. A successful inspection outcome is required for the acquisition and renewal of GDP Certification.

The planning of audits and Audit Program Management are therefore critical elements in maintaining safety and operational efficiency.

Click here for more information from the European Medicines Agency (EMA) on GDP guidelines.

When conducting Good Distribution Practice (GDP) audits, it is essential to employ appropriate risk-based sampling and testing methods. These methods enable the identification and assessment of specific risks in the area under review, with the audit findings methodically documented in an audit plan.

Risk is assessed at the following audit planning levels:

Strategic Level Audit Planning: This phase involves the development of a long-term audit strategy requiring endorsement from senior management.

Tactical Level Audit Planning: The tactical level focuses on creating an audit program that outlines audit objectives and the scope of audits within that program.

Operational Level Audit Planning: At the operational level, the focus is on crafting an audit plan for individual audit engagements. This involves prioritizing audit tasks based on a risk-based methodology, reporting audit findings in alignment with their relative risk levels and providing ranked or graded audit recommendations.

A GDP Audit must therefore gather essential evidence, including pertinent documentation and statements, which can subsequently undergo objective evaluation against the applicable compliance and risk criteria.

Common areas within a GDP safety audit.

A GDP audit should be a methodical, independent, and well-documented review that includes:

The conditions and controls for products during storage and transportation such as temperature and humidity to maintain quality and efficacy.
The contamination risk for products during storage and transportation.
Security, and measures for the prevention of counterfeiting such as Serialization, Tamper-Proof and Tamper-Evident Packaging, Track-and-Trace Systems etc.
The delivery, timelines, and handling of products during storage and transportation.

The storage and turnover of products at their destination.
The Quality Management System (QMS) and procedures for CAPAs and Deviation Management, Product Recalls, Product Returns, Product Quality Complaints, other Customer Complaints, Personnel Training & Competence, etc.
Documentation and recording related to receipt, storage, and distribution to confirm accuracy, completeness, and maintenance for required retention periods.

Why choose Aegisana for your GDP Auditing?

A collaborative approach.

Our GDP Compliance team is thoroughly experienced in the full scope of GDP requirements and the auditing services required to keep your distribution chain safe, compliant, and inspection ready.

Through a collaborative approach, our process focuses on:

Audit planning and defining audit scope and objectives. Developing an audit plan outlining the areas to be assessed, audit methods, and the audit schedule within your Audit Program.
On-site inspections of facilities involved in the distribution process, including personnel interviews and process observations/assessment.
Documentation review including standard operating procedures (SOPs), records, and quality management system documents.
Data collection for key performance indicators, incidents, and deviations related to distribution activities.
Awareness through interviews and assessment of personnel at different levels on the knowledge of GDP requirements.
Communicating of findings and observations with relevant stakeholders.
Comprehensive audit reporting detailing observations, non-compliance issues, and recommendations for improvement.
Prioritizing of findings based on their impact and risk.
Developing CAPA plans for identified issues.
Conducting follow-up audits to verify the implementation of Corrective Actions.

Experience & commitment.

Our internal and external GDP auditors are experienced and qualified and understand the latest in regional legislation changes and requirements.

Supported by a robust Quality Management System (QMS), we can seamlessly and efficiently adapt to the compliance needs of your distributed products. Our commitment to good communication, reliability, and trust aims to foster a successful and resilient strategic partnership throughout the entire life cycle of your product portfolio.

Our goal is to provide you with peace of mind and confidence by thoroughly reviewing and assessing all your distribution compliance processes, with all levels of risk clearly identified and communicated in our audit findings.

Through effective communication, reliability, and trust, we aspire to establish a successful and robust strategic compliance and auditing partnership throughout the entire life cycle of your human and animal products.

All of our services adhere to the regulations and principles of the EMA’s guidelines on compliance.