Discover how QbD Group helped a client tackle dual validation challenges for their production lines, ensuring GMP compliance and AEMPS approval.
In 2022, a longstanding client who had previously engaged our services for Risk-Based Environmental Monitoring (RRAA) sought our expertise for their Cleaning Validation initiative across their production lines handling Oral Solid Forms (OSF), Semi-Solids, and Sterile products. This project demanded a holistic approach, encompassing everything from toxicological evaluations, including Permitted Daily Exposure (PDE) assessments, to preparation of essential quality documentation. This project represents a collaborative effort, with both our toxicology and quality assurance departments actively engaged.
The challenge was twofold: first, to conduct comprehensive cleaning validations essential for product registration under GMP guidelines, and second, to ensure strict compliance with these validations for impending agency inspections.
Our approach is founded on delivering top-tier service, professionalism, expertise, and profitability.
QbD Group ensures seamless coordination across all departments for efficient service delivery. A multidisciplinary project management team oversees timelines, milestones, and client communication, ensuring agile and transparent collaboration throughout the project.
While the project remains ongoing, notable progress has already been made in the Cleaning Validation process. Our client is now equipped with all required documentation.
A positive inspection by the Spanish Medicines Agency (AEMPS) underscores our dedication to upholding quality and regulatory standards.
QbD Group
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