Challenge
While the extraction process itself is complex—extracting chondroitin sulfate from animal cartilage—the documentation is, if possible, even more complicated.
The pharmaceutical industry operates under strict regulations to ensure compliance with cGMP, and all processes must be documented and approved to meet regulatory requirements from the Danish Medicines Agency, the Danish Veterinary and Food Administration, and general customer requirements. That’s why implementing an electronic quality management system takes longer in our industry than in most others.
Solution
Before getting started, we conducted an audit of IPW’s system validation. When developing forms, we must carry out risk assessments, a User Requirement Specification, a validation protocol, and a validation report. Even for updates, the system must be revalidated — and every step of the testing process must be documented.
With digital document management in IPW, documents are now easily accessible, simple to revise, and can be versioned and tracked. The forms provide an overview of deadlines and responsible parties. The system logs everything, ensures read-and-understood confirmations, and manages approval workflows—eliminating the need for paper-based approvals across multiple departments.
Result
We now have far better visibility into our process steps, and the value of the system is clear — across procurement, production, engineering, and QA. No more running around chasing signatures.
What’s more, we can tailor IPW precisely to fit pharmaceutical practice and build it ourselves. So far, we’ve set up forms for deviations, corrective actions, audits, supplier management, and incident reporting.
Next up are change management, complaints, and OOS (Out of Specification) handling. Everything we manage in IPW forms is now completely paper-free
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Smooth approval workflows and a clear overviewof processes, deadlines, and responsibilities.
Full overview of supplier status. Unified document management, continuousevaluation, and easy verification of initial samples for new suppliers
Easy tracking of deviations and changes, creating KPIs and management reviews. Generation of annual PQR (Production Quality Review) and follow-up statistics for prensentations
Rikke Spangsberg Jørgensen, QA Specialist
ZPD A/S
The orginally Danish ZPD extracts chondroitin sulfate under the highest standards to combat osteoarthritis and joint problems in the pharma, food, and feed industries. The company operates in Esbjerg and employs approximately 40 people. ZPD is Japanese-owned and part of the Zeria Group, which has over 1,800 employees worldwide.
www.zpd.dk