Quality excellence - Optimizing QC and QA in a Biopharma

Background and Objectives

The need

A BioPharma multinational needed to analyze its QA and QC operating model (organization, processes and IT systems) in order to identify efficiency levers to sustain future growth.

The goals

Identification of the main areas of optimization regarding QC and QA organization, processes and systems.

The project

  • Current operating model assessment
  • Design of improvement solutions and estimate of expected benefits.
  • Development of the implementation plan of the identified solutions.

Approach

01.

Identification of improvement opportunities

  • Use of different analytical tools and methodologies to analyze the performance of current QA and QC model (benchmarks, live observations, process and data analysis, etc.).

02.

Operating model redesign

  • Identification of the main QA & QC models optimization areas, with particular focus on QA (e.g., deviation management, CAPA, change control, etc.).

03.

Final recommendations

  • Design of process and IT improvement solutions (e.g., risk mgmt. approaches, streamlining of core QA flows via automation, QC staffing optimization, etc.), estimate of expected benefits and design the implementation plan

Key Outcomes