Case Study
UST ensures timely, cost-effective product stability via packaging compliance and quality control
OUR CLIENT
Providing a wide range of trusted health and wellness products, the client is a leading global consumer health organization specializing in over-the-counter medications, skincare, and personal care items used by millions of consumers. The company is committed to innovation, leveraging science and research to develop products that improve daily health and well-being. With a portfolio that includes several iconic brands, the company has a strong presence in households across multiple countries. It operates with a focus on sustainability, ensuring that its products are both effective and environmentally responsible. The company’s dedication to quality and consumer trust has made it a key player in the global health and wellness industry.
THE CHALLENGE
Product packaging changes prompts the need for stability testing and method validation
A large pharmaceutical company had recently implemented packaging changes in several commercial products utilized by the client. As a result, many of the client’s products had to undergo rigorous stability testing to confirm that the new packaging did not adversely affect the products' quality over time.
The client also needed to conduct method validation studies to ensure that the analytical methods used to test the products under the new packaging conditions were accurate, reliable, and reproducible.
Detailed protocols outlining the procedures and criteria for the stability testing and method validation studies had to be prepared to serve as a roadmap for both the scientific and regulatory teams. Comprehensive reports following study completion would also be needed.
This process was essential not only for maintaining regulatory compliance but also for ensuring that the products could be safely and effectively launched or re-released into the market. The preparation and execution of these protocols and reports were critical steps in the change control process, allowing the client to confidently move forward with the distribution of their commercial products under the new packaging.
THE TRANSFORMATION
Improved efficiency in QC processes for required stability testing and method validation for packaging changes
UST assembled an experienced team of scientists to coordinate and support the client’s quality control (QC) efforts. Through a collaborative approach, our team managed the extensive testing requirements necessitated by the packaging modifications, including oversight of stability testing studies and method validation processes. UST’s scientists also helped prepare the supporting documentation essential for maintaining compliance with industry regulations and providing a clear record of the testing processes and outcomes.
The team provided detailed timelines and resource requirements, giving the client a clear understanding of the project’s scope and necessary commitments. They also consulted with the client on process improvement opportunities, identifying areas where QC processes could be enhanced for future projects.
The client can now effectively manage complex packaging changes by seamlessly coordinating stability testing, method validation, and compliance documentation processes that were previously difficult to execute. Additionally, the company is better positioned to streamline and optimize its QC operations. It benefits from UST’s process improvements and strategic insights, which allow for more agile and effective responses to future changes.
THE IMPACT
Timeline management leads to efficiency and cost savings in product testing
Our client saw significant financial savings, reduced complexity, and timely completion throughout the product testing process. These advantages not only improved the project’s immediate outcomes but also enhanced the client’s overall operational efficiency and ability to manage future projects. The streamlined processes and methodologies developed during this engagement can be applied to similar projects, offering ongoing value.
Ultimately, the client benefited from a project that was completed efficiently and cost-effectively and delivered results that strengthened their product stability and market readiness.
Highlights of the project management:
- Accelerated project timeline: Streamlined testing methods reduced overall project complexity, avoiding unnecessary complications and focusing on critical aspects of testing.
- Lab testing efficiencies: By ensuring all tests were conducted correctly the first time, our client successfully demonstrated product stability under the new packaging conditions. This meticulous approach to testing gave the client the confidence that their products would perform reliably in the market.
- Meeting project deadlines: Staying on schedule for product releases allowed the client to avoid potential market entry delays that might have impacted revenue and customer satisfaction.
- Cost savings: The client significantly reduced costs by accelerating the project timeline, managing testing efficiency, and meeting deadlines.