Quality Remediation project

The site, a key part of the company’s regional network, had major long-term GMP issues.

Following WHO and South African MCC inspections, it had been issued with a Notice of Concern and was required to complete a rigorous programme of remediation activities and commitments. We were able to provide external guidance, both in terms of specialist expertise and extra ‘horsepower’.

Our role included:

• Identifying and planning corrective actions
• Monitoring and controlling progress against the schedule
• Verifying that actions had been completed
• Mentoring and transferring knowledge to local QA and QC teams
• Progressing and implementing specific improvement projects
• Introducing new ways-of-working and management practices
• Supporting Out-Of-Specification investigations
• Managing the Control Room during the inspection
• Implementing quick fixes during and immediately after the inspection
• Preparing the Response document
• Supporting and monitoring the closure of audit commitments and provide updates to inspecting authorities
• Identifying and planning further remediation activities

The inspection was a great success, and the inspectors praised the improvements that had been introduced since the last inspection. The Notice of Concern was lifted.