Challenges
The pharmaceutical industry faces increasing pressure to maintain regulatory compliance while ensuring efficient, high-quality production. As global supply chains expand and regulatory requirements from agencies become more stringent, manufacturers must demonstrate rigorous adherence and quality management standards.
For global Contract Development and Manufacturing Organizations (CDMOs) like CordenPharma, the challenge is amplified by the complexity of serving multiple clients, each with different products, documentation needs, and regulatory expectations. Inconsistent documentation, fragmented SOPs, and varying levels of training compliance can create bottlenecks, increase audit risks, and slow down the ability to scale production for innovative therapies. SILREAL supported CordenPharma in addressing these challenges by streamlining documentation processes, strengthening regulatory compliance, and driving digital quality transformation across global operations.
Approach
SILREAL addressed these challenges and partnered with CordenPharma to modernize its global quality and compliance systems in response to increasing regulatory demands and operational complexity. The engagement focused on streamlining documentation workflows, standardizing SOPs, and digitizing quality management practices. By aligning people, processes, and technology, SILREAL enabled CordenPharma to strengthen audit readiness, reduce compliance risks, and establish a scalable framework for long-term operational excellence.
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Regulatory & Compliance Assessment: Conducted a detailed review of existing GMP documentation, qualification records, and audit reports to identify gaps in compliance and areas for immediate improvement. This assessment provided the foundation for a stronger, more unified quality management system.
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Documentation & SOP Standardization: Streamlined fragmented documentation by harmonizing Standard Operating Procedures (SOPs) across departments and sites. SILREAL introduced consistent templates, clarified approval workflows, and ensured that SOPs met international regulatory expectations.
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Digital Quality Management Implementation: Supported the global rollout of the D3 CAP system, digitizing failure reporting, incident tracking, and documentation archiving. This ensured central oversight, traceability, and faster response times during audits and inspections.
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Training Compliance & Workforce Alignment: Introduced structured training programs, qualification lists, and digital tracking mechanisms to ensure all employees were properly trained and certified. This not only improved compliance but also strengthened staff accountability and operational resilience.
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Audit Readiness & Continuous Process Improvement: Established proactive systems for batch record reviews, audit observation tracking, and risk-based monitoring. These practices enhanced transparency, minimized regulatory risks, and embedded a culture of continuous improvement in CordenPharma’s operations.
Result
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Enhanced Regulatory Compliance: Strengthened adherence to international GMP standards by closing documentation gaps, aligning SOPs, and ensuring consistent training compliance across sites, reducing regulatory risk exposure.
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Streamlined Documentation & SOP Management: Introduced standardized documentation practices and optimized approval workflows, enabling faster audits, smoother inspections, and greater operational transparency.
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Successful Digital Quality Rollout: Implemented the global D3 CAP system, providing centralized oversight of failure reporting, incident tracking, and archiving. This digital transformation improved traceability, reduced manual errors, and increased efficiency.
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Improved Audit Readiness & Risk Management: Established proactive monitoring of batch records and audit observations, which enhanced inspection readiness and ensured continuous compliance improvements.