As specialized compliance consultants in the life sciences sector, msg industry advisors are the partner of choice for companies in pharmaceutical logistics. With in-depth expertise in Good Distribution Practice (GDP) and comprehensive knowledge of GxP compliance, they provide valuable support to specialized logistics companies—particularly when critical customer audits are pending or audit findings need to be addressed. Below, we explain how msg industry advisors help pharmaceutical logistics companies efficiently implement compliance requirements and ensure long-term audit readiness.

GDP Compliance and Pharmaceutical Logistics: msg industry advisors as a Strategic Partner

The pharmaceutical industry is subject to strict regulations to ensure the safety and quality of its products. This also applies to the storage and transportation of pharmaceutical goods, where GDP guidelines enforce adherence to the highest standards.

Support for Customer Audits and Addressing Audit Findings

Customer audits are a central component of quality management in the pharmaceutical sector. When audits are announced or “audit findings” are already identified, quick and targeted action is required. msg industry advisors provide comprehensive support in five steps:

1. Preparation and Execution of Mock Audits: Mock audits are a core component of our audit preparation. They allow potential weaknesses to be identified and addressed in advance. These proactive reviews help defuse critical points and prepare the organization for the actual audit.
2. Training and Education: Through specialized training for employees, we ensure they are familiar with GDP compliance requirements and know how to respond correctly during an audit. This increases audit readiness and reduces the likelihood of findings.
3. Organization and Back-Office Support During Audits: During the audit, we provide back-office support to ensure smooth communication and document management. This includes providing scribes and a structured ticket system that captures and documents all relevant information.
4. Post-Audit Follow-Up and Lessons Learned: After the audit, it is essential to systematically analyze the results and experiences. We conduct Lessons Learned sessions and develop an “Always Ready” package to maintain audit readiness over the long term.
5. Documentation and Addressing Audit Findings: If deficiencies are identified during an audit, we provide targeted measures to resolve these findings. This includes detailed documentation of necessary adjustments and the implementation of Corrective and Preventive Actions (CAPAs) to ensure deficiencies are sustainably addressed. We assist in classifying, tracking, and resolving CAPAs effectively.

Data Integrity and Risk Management in Pharmaceutical Logistics

A key element of GDP compliance in pharmaceutical logistics is ensuring data integrity according to the ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate). msg industry advisors offer comprehensive solutions to ensure data quality and integrity, which is particularly crucial when addressing audit findings. Our consultants conduct detailed Data Integrity (DI) assessments, examining and documenting the authorization, accessibility, storage, and retention of relevant data. In logistics, GDP violations often occur in areas like proof of cold chain integrity, storage conditions, or distribution—particularly when validated and secure digitalization solutions are not yet in place.

Specific Approaches for IT System Validation and Qualification

In GDP compliance, the validation and qualification of IT systems are essential to meet regulatory requirements. We rely on best practices, such as GAMP5 Versions 1 and 2, and other industry standards to ensure all relevant processes comply with required regulations.

Key aspects of IT system validation and qualification include:

• Risk-Based Evaluation and Adjustment of IT Systems: We conduct individual risk assessments for IT systems based on a combination of likelihood of occurrence and impact. This approach enables adjustments tailored to the specific requirements of pharmaceutical logistics, balancing compliance, quality, and economic demands.
• Prospective, Risk-Based CSV Activities: By applying a critical-thinking approach, all CSV (Computerized System Validation) activities are prospectively planned based on risk analyses, ensuring both efficiency and compliance.
• Automated Test Processes: We use state-of-the-art test management tools to optimize testing processes and ensure compliance with GDP requirements.

msg industry advisors: A Strong Partner for GDP Compliance and Pharmaceutical Logistics

In a sector defined by strict regulatory requirements and high-quality standards, msg industry advisors provide pharmaceutical logistics companies with reliable support. From precise audit preparation to addressing findings and validating IT systems, we guide companies through the entire audit process. With a team of experienced consultants and a comprehensive range of methods, we not only ensure GDP compliance but also help companies continuously develop and improve all their compliance processes.

By combining industry expertise, process optimization, and technical proficiency, we deliver sustainable value to our customers.