Streamline of expert assessment process for Nitrosamines Project

A Swiss pharmaceutical company sought assistance in streamlining their expert assessment process for a Nitrosamines Project to address regulatory requirements efficiently. They needed support in coordinating cross-functional teams, managing complex data, and ensuring consistent evaluations across products. The focus was on establishing clear workflows, enhancing communication, and creating standardized tools to improve the accuracy and speed of the assessment process while maintaining compliance.

Challenges Faced

Complexity of Expert Assessment: The most prominent issues included managing a high volume of complex data inputs, ensuring consistent interpretation of evolving regulatory guidelines, and coordinating among multiple internal teams
Document Volume: Constraints on available expertise and resources, along with integrating findings into existing workflows, were shown as significant hurdles.
Documentation: Experts faced difficulties due to the absence of master data and a centralized documentation repository. Without a single, consolidated source of information, the process of evaluating drug products became time-consuming. Multiple disconnected data sets, varying formats, and unclear points of reference led to inconsistencies, inefficiencies, and potential risk of errors in their assessments.

Zamann Pharma Support’s Approach

Project Initialization: A clearly defined workflow was needed to standardize the evaluation steps for expert assessments in the Nitrosamines Project. This involved outlining the sequence of tasks, assigning responsibilities, and creating formalized procedures for reviewing data and making decisions.
Expert Evaluation: Establishing regular checkpoints, consistent documentation methods, and clear communication channels ensured that the evaluation process remained organized, efficient, and aligned with regulatory expectations.
Expert Assessments Documentation: Templates needed to be carefully structured to include all relevant information about each drug product, ensuring consistency and completeness in expert assessments. These templates captured essential details such as product composition, manufacturing history, and potential nitrosamine risk factors. By standardizing formats and content, the templates supported more systematic evaluations, allowed for easier data comparison, and reduced the likelihood of errors or omissions. This approach simplified the expert assessment process and facilitated timely, accurate decision-making.
Communication: Priority drug products were clearly identified and communicated to experts through established channels and documentation. This involved sharing regularly updated lists, criteria for prioritization, and any underlying regulatory deadlines. By providing transparent guidelines and consistent communication, the experts could focus their efforts efficiently, ensuring that critical assessments received attention first and contributing to timely, informed decision-making.
Support for Implementation: Workstreams were trained through a structured program designed by subject-matter experts, covering each step of the defined process. Clear guidelines, hands-on demonstrations, and practical examples helped participants understand their roles and responsibilities. This ensured everyone involved had the necessary knowledge and skills, leading to consistent, efficient execution and alignment with established standards.

Results Achieved

Regulatory Compliance: By defining a clear, structured expert assessment process, regulatory requirements were fully integrated into each phase of evaluation. Detailed guidelines ensured that all stakeholders followed approved protocols, used validated methods, and maintained proper documentation.
Improved Documentation: By establishing a well-defined expert assessment process, the quality and consistency of evaluations significantly improved. Clear criteria, standardized templates, and structured workflows ensured that experts could focus on meaningful analysis rather than administrative hurdles. This led to more accurate, timely, and reliable assessments, ultimately enhancing decision-making and supporting better outcomes.

Client Testimonial

“Our project reached a successful conclusion thanks to the focused efforts of a smaller group of experts supported by a strong operational team. The streamlined approach allowed us to manage workloads more effectively, maintain quality standards, and deliver timely results. The operational support filled any gaps, ensuring data was organized, communication was clear, and processes ran smoothly. We found that this leaner model improved both efficiency and outcome quality, surpassing our expectations.”

Contact Us

Need help? Don't hesitate to get in touch

First Name*

Last Name*

Email*

Phone number*

Role*

Department*

Country

Industry

Question submitted

Zamann pharma support is committed to protecting and respecting your privacy, and we’ll use your personal information to administer your account and to provide the products and services you requested from us.

Yes, I agree to receive personalized newsletters with market insights, invitations for exclusive events and educational webinars from the Zamann Pharma Support GmbH.

I consent to the privacy policy and understand that my personal data will be stored and processed*

Siedlerstraße 7 | 68623 Lampertheim, Germany

info@zamann-pharma.com