Impact in Action

Client Challenge

A large-scale sterile manufacturing site in China — employing over 1,200 people and producing Blow Fill Seal (BFS) vials with a corticosteroid suspension — required an initial EU GMP audit as a critical first step toward EU GMP certification. The audit needed to be performed by a Qualified Person (QP) and would serve as a trigger for inspection by a European competent authority. Given the complexity of sterile production, the size of the site, and the regulatory expectations involved, the client needed a deep and structured assessment of their existing Quality Assurance (QA) system.

Our Approach

We conducted a 3-day on-site audit, with myself acting as lead auditor, supported by two experienced co-auditors. The audit covered all critical aspects of sterile manufacturing and QA systems, including:

• EU GMP Pharmaceutical Quality System assessment (including Site Master File (SMF), Contamination Control Strategy (CCS), organizational structure and job descriptions, training system, QRM, MRM, deviations, supplier qualification and many other elements).
• Cleanroom design, site layout and flows, utilities, gowning, environmental monitoring.
• Manufacturing process validation and equipment qualification.
• Analytical and Microbiological QC activities.
• Data integrity practices.
• And more...

The approach was rigorous but collaborative, creating an open dialogue between us as auditors and the client’s QA, production, and engineering teams.

The Result

The audit was a success. Both auditors and auditees gained valuable insights through mutual knowledge exchange, and the outcome was a clear report detailing strengths, observations, and well-defined improvement points. This gave the client a realistic and structured roadmap toward EU GMP certification — with specific attention to sterile production risks and international best practices.

With a solid foundation now in place, the client is confidently preparing for the next milestone: a successful EU competent authority inspection.

Client Challenge

The client approached us at a very early stage — with little more than a facility previously used as an indoor playground. Their ambition was bold: to transform this space into a fully GMP-compliant and certified manufacturing area and warehouse. Starting from scratch meant navigating everything from layout and product flows planning to creation of the Quality Management System.

Our Approach

We supported the client from the ground up — quite literally.

• We began with the layout and flow design, ensuring that material, personnel, and waste flows aligned with GMP principles.
• From there, we developed the economically efficient technical infrastructure, balancing regulatory requirements with cost-effective execution.
• A Quality Management System (QMS) was built from the ground up, tailored specifically to the client's operations and future plans.
• We conducted the implementation process, trained the team, and prepared the organization for its first regulatory inspection.

The Result

The outcome was a success: the facility passed its GMP inspection on the first attempt, earning its certification. What began as an unconventional starting point — an old indoor playground— was transformed into a fully operational, GMP-certified site, complete with a robust and functioning QMS. The project is a testament to what can be achieved with clear vision, planning, and hands-on regulatory expertise.

Client Challenge

A pharmaceutical company found itself stuck in the process of Compliance Management, where their Quality Management System existed primarily to pass audits — not to support daily operations or long-term growth. Regulatory pressure was high, and the system lacked integration with on-the-ground reality.

Our Approach

We partnered closely with the client during a highly challenging period, guiding them through a full transformation of their QMS. The goal was not just to achieve compliance, but to embed Good Manufacturing Practice (GMP) principles into the organization’s day-to-day operations in a meaningful and sustainable way.

This involved:

• Mapping the existing QMS and identifying critical gaps.
• Reframing quality as a strategic asset rather than a plain cost.
• Rebuilding processes and documentation to reflect both regulatory standards and operational reality.
• Aligning stakeholders across departments.

The Result

What started as a system focused solely on surviving inspections evolved into a mature, fully integrated QMS that met all GMP requirements — in both detail and spirit. More than just compliance, this transformation became a source of pride for CAPA — "a star on the uniform" — symbolizing ownership, resilience, and drive. The organization emerged with a system that supported not just the company, but also the patient.

Client Challenge

A distributor of nuclear medicine wanted to establish a new site in Belgium and needed a fully compliant Quality Management System (QMS) aligned with Good Distribution Practice (GDP) standards and local best practices.

Our Approach

Starting from a clean slate, we worked closely with the client to design and implement a QMS tailored to the specific demands of distributing nuclear medicine. Given the complexity and risk profile of these products, the system had to go beyond standard compliance.

Key steps included:

• Performing a detailed regulatory and process assessment.
• Structuring the QMS around GDP principles, with clear roles, responsibilities, and documentation.
• Introducing risk-based quality controls, training programs, and procedures.
• Aligning internal workflows with regulatory expectations and operational efficiency.

The Result

The client now operates with a robust, fully GDP-compliant QMS that supports both regulatory inspections and daily operational efficiency. The system enables confident handling and distribution of nuclear products while minimizing compliance risk.

Client Challenge

A pharmaceutical distributor faced a compliance issue within its customer qualification process. Due to system limitations, unauthorized sales could not be effectively prevented. Although mitigating actions like staff training were implemented, the low detectability of the issue meant that critical errors could still slip through unnoticed — posing significant risks under Good Distribution Practice (GDP) regulations.

Our Approach

Since the existing ERP systems lacked the flexibility to solve the problem, we developed a custom software solution tailored to the client’s compliance needs.

The tool:

• Automatically scanned every invoice on a monthly basis.
• Cross-referenced customer data against up-to-date official databases.
• Generated a data integer PDF report with timestamp and a clear list of required actions (if any).
• If no issues were detected, the user simply had to sign and archive the report — dramatically reducing manual overhead.

We also advised the client that while a risk-based sampling method could theoretically guide the monthly control process, the complexity and margin for error made a fully automated approach much more suitable.

The Result

The solution delivered certainty, without relying on sampling or manual review and with zero risk of human error. This project is a strong example of how custom software can close critical compliance gaps where standard tools fall short.

Client Challenge

The client’s system (Contract Manufacturer) for In-Process Controls (IPC) was disorganized and outdated. IPCs were logged using a patchwork of copied forms, multiple generations removed from the original. In batch documentation, it was often unclear which forms needed to be filled out, and no standardized instructions were available for operators. The result: confusion on the floor and time-consuming corrections during batch record reviews.

Our Approach

We began with a thorough analysis of each production process, identifying similarities and differences in documentation and execution. From there, we implemented:

• A standardized system of IPC forms tailored to each product group and process.
• Clear, uniform instructions integrated with the existing QMS.
• Targeted training to ensure all operators understood and followed the new procedures.

The Result

The new system dramatically reduced post-production issues during batch record reviews, saving time and minimizing compliance risks. By bringing structure, clarity, and training into the QA process, the client moved from reactive corrections to proactive quality control — less stress, fewer errors, and a far more efficient documentation flow.

What starts with a gap, a stressed QA team, or a rushed inspection prep, doesn’t have to stay that way... Your story could be next.