On-Site Evaluation (OSE) Preparation Facilitates Early Licensure of New Biological Drug

Case Study #10_OSE Preparation

An international client required support to address recent findings from an FDA inspection and prepare for an On-Site Evaluation (OSE) by the Biologics & Genetic Therapies Directorate (BGTD). Brevitas provided GMP advice and coaching which facilitated the successful execution of the OSE, with no observations.

Industry

Biologics

Area of Expertise

Regulatory Compliance

Duration

1 month

Services Provided

  • Project Management
  • Inspection Readiness
  • Technical Documentation

Impact

Due to Brevitas’ GMP advice and coaching, covering facilities and operations, an international client was able to successfully prepare for and successfully complete an On-Site Evaluation, in preparation for the licensure of their new biological drug.

Business Challenge

Our international client is part of a complex inter-site arrangement with locations in several geographical regions. After an FDA inspection, the manufacturing site showed several areas of concern that could potentially impact the approval for licensure of the client’s new biological drug. Brevitas consultants were brought in for assistance in preparing their manufacturing site for an On-Site Evaluation (OSE) by the Biologics and Genetic Therapies Directorate (BGTD) for the Pre-License Inspection of the new product.

Our Approach

Brevitas worked with the parent client site and sister sites to assess the findings and proposed remediation plans for the FDA 483. Brevitas also assessed the performance and compliance status of key quality systems (including change management and regulatory reporting, CAPA, and nonconformance handling). Several risk areas were identified, along with avenues that the inspection would likely follow. Brevitas consultants performed an assessment against regulatory compliance requirements and provided recommendations for further improvement covering quality systems, facilities, aseptic processes, and operations prior to the BGTD On-Site Evaluation. The consultants followed up with coaching and GMP advice during the OSE to ensure adequate supporting data and appropriate responses to inspection inquiries.

Results Achieved

As a result of Brevitas’ extensive efforts, the OSE was successfully executed, with no inspectional observations being raised by the BGTD. This outcome helped facilitate the early licensure of their new biological drug.

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