Oxford’s Validation Program Helps Streamline Operations and Ensure Compliance

SITUATION

Our client, a leading manufacturer of natural personal care products, specifically toothpaste, needed a highly skilled validation engineer to address critical gaps in their current validation processes. Their primary requirements included extensive experience in complete validation of water systems, cleaning validation, and sanitization. Additionally, they needed support in writing validation protocols and conducting validation for pull time studies. While all necessary data had been collected, there were significant gaps in their validation processes that required immediate attention to ensure compliance, efficiency, and safety.

SOLUTION

To address the client’s needs, our team focused on developing and executing validations across key areas critical to their manufacturing operations, including:

• Cleaning & Sanitization (C&S) Processes
• Water & Critical Utility Systems
• Computer Control Systems
• Protocol Writing & Pull Time Studies

Additionally, the validation program was designed to integrate seamlessly with the plant’s existing quality management systems, including:

• Management of Change (MoC)
• Technology Transfer
• Calibration, Facilities & Equipment, Preventive Maintenance

RESULT

Our team successfully developed and executed a comprehensive validation program for the client, covering water systems, cleaning processes, and critical utilities. This ensured efficient, safe, and regulatory-compliant manufacturing processes. The validation efforts streamlined operations and reduced contamination risks, crucial for maintaining product quality in the natural personal care product market. We will continue to support the client’s site, providing ongoing validation assistance and ensuring long-term compliance, with support extending until at least the end of the year.