Optimizing Pharmaceutical API Processes
Explore how our systemic approach to API processes yielded close to 100% reduction of API content variation and a reduction of batch scrap rate from 40% to 10%.
Good stories
A leading Nordic pharmaceutical company needed to implement a new test method to ensure the quality of a new therapy for clinical studies in humans. Emendo R&D was brought on board the project to actively participate in the development, validation, and implementation of the method.
THE CHALLENGE
To ensure the quality and safe use of a novel drug substance, a Nordic pharmaceutical company engaged Emendo R&D through our pharmaceutical consulting services to support the implementation of a new analytical method.
The main challenge was transitioning the method between two departments. One department focused on method development without GMP constraints, while the other worked under GMP regulations and lacked experience with the method.
The transition required understanding the receiving department’s needs and ensuring compliance while maintaining the analytical method’s accuracy and reliability.
THE SOLUTION
Emendo R&D managed the project and led the validation and implementation of the new analytical method within the GMP-regulated unit.
This involved mapping and coordinating over 20 activities across 5 functional areas. They defined the analytical strategy and provided training to technicians and scientists. All while ensuring compliance with ICH Q2 and the company’s quality management system.
As detailed further in our white paper on Analytical Method Development and Validation, Emendo R&D created Standard Operating Procedures (SOPs) for the method and the instrument used in the analysis. Our consultants also developed guidelines for data analysis, protocols, and reports to support regulatory audits.
THE RESULTS
By partnering with Emendo R&D, the company achieved a smooth transition between departments. The uncertainty associated with the introduction of a new analytical method was removed and the foundation for robust analysis was laid. The result was an empowered team with the confidence and ability to perform the appropriate analyses and meet future challenges.
“By partnering with Emendo R&D we’ve been able to implement a new analytical method in our department which has helped us ensure the quality of a new drug substance. Emendo R&D has provided valuable scientific knowledge, driven the project with great oversight and enthusiasm, and has ensured a smooth transition of the analytical method to our department. We’ve been very pleased with the process.”
Head of the department at the client
“We recognize that projects are not driven by software, processes or tools, but by people. By putting people at the center of everything we do and giving credit to those who are committed to the project, we have not been only able to create great synergy between Emendo R&D and the client, but also overcome the challenges we have encountered along the way.”
Executing Consultant, Emendo R&D
Working closely with the client, Emendo R&D was responsible for:
If you’re facing challenges in transitioning new analytical methods within your GMP-regulated environment, our team can guide you through the validation, training, and implementation process. Let us help you ensure compliance and build the confidence needed for successful clinical trials.
Reach out to Britt Dam Raaby, Vice President at Emendo R&D, and discover how our experts can help you deliver results with confidence.
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HAVE A QUESTION
Analytical method validation is the process of proving that a laboratory test method produces reliable, consistent, and accurate results. It is essential for ensuring product quality, regulatory compliance, and confidence in data during product development and manufacturing.
Implementing a new analytical test method involves developing standard operating procedures (SOPs), validating the method according to regulatory guidelines (such as ICH Q2), training relevant personnel, and coordinating activities across departments to ensure consistency and compliance.
Key challenges include aligning processes with different regulatory requirements, ensuring personnel are properly trained, maintaining data integrity, and managing coordination between departments with varying expertise and experience levels.
Project management ensures that all validation activities are identified, scheduled, and executed efficiently. It helps coordinate multiple departments, track progress, resolve issues quickly, and maintain compliance with internal and external regulatory requirements.