Audit of Quality Management Systems in the Pharmaceutical Industry

Initial Challenge

The client, a European supplier of active substances, faced repetitive observations from regulatory authority auditors, particularly related to tracking and documenting deviations in production processes. The lack of a clear structure for reporting non-conforming events posed significant risks to ISO 9001 certification and the manufacturing license.

Analysis and Intervention Process

We implemented a three-phase audit methodology:

1. Process Mapping: Comprehensive documentation of the production flow, from raw materials to finished product, identifying all critical control points.
2. Documentation System Assessment: Analysis of all existing forms, registers, and procedures for deviation management, identifying gaps and redundancies.
3. Workshops with Key Personnel: Interactive sessions with production managers, quality assurance, and operators to understand practical challenges in real-time reporting.

Implemented Solution

We designed and trained the team on a new unified non-conforming event management system. It included:

• A standardized initial reporting protocol, with mandatory fields and severity classification criteria.
• A clear root cause investigation procedure, with assignment of responsibilities and deadlines.
• A centralized electronic register for tracking the status of each case and generating reports for management and authorities.