Compliance Support Leading to Reduction and Closure of Quality Notifications

Compliance Support

In order to meet the constant demand for their products, our Global Pharmaceutical client retained the services of Brevitas consultants to provide compliance support and address open Quality Notifications by special investigation and effective root cause corrective actions.

Industry

Pharmaceuticals

Area of Expertise

Compliance & Operational Effectiveness

Duration

6 months

Services Provided

  • Root Cause Corrective Actions
  • CAPA and Change Control Management
  • Technical Writing

Impact

The special investigations into compliance-related issues prevented the initiation of repetitive Quality Notifications and contributed to the reduction of overall Q-Notes.

Business Challenge

As a leading Global Pharmaceutical Company, our client became concerned with their capability to close all their Quality Notifications (Q-Notes) in a timely fashion. They were also very committed to developing an overall understanding of all compliance issues affecting their operations and applying new processes that would allocate their resources more appropriately without having a significant impact to their overall Quality Operations. Brevitas consultants were brought in to provide compliance support and address open Quality Notifications by special investigation and effective root cause corrective actions.

Our Approach

We played an active role in providing optimum reports into compliance related-issues by performing special investigations, gathering, analyzing, and summarizing all data. This involved a thorough, exhaustive investigation into all initiated Q-Notes and implementation of effective root cause corrective actions (RCCA) and change control management activities.

Results Achieved

From beginning to end, the Brevitas consultants contributed to the success of this project by:

1. Decreased the number of open Q-Notes by 50% on target within a 6-month period:

  • Organized and tracked the status of all open Q-Notes, corrective actions, and change controls
  • Ensured that all the work provided was in compliance with all updated SOPs, regulatory requirements and established standards
  • Developed metrics to highlight the performance of completion of quality deviations

2. Provided recommendations and follow-up of CAPAs, Change Controls and training to personnel related to technical service deviations

3. Identified the recurring issues and implemented improvement plans in collaboration with the area managers and other stakeholders in order to reduce the occurrence of new deviations

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