close

Pharma Quality Assurance Benchmarking

Benchmarking Operational Excellence in Pharmaceutical Quality Assurance: Compare your performance and maturity level to industry peers, understand your enablers, and discover potential for improvement.

Quality Assurance (QA) is essential for ensuring product quality, compliance, and robust operations. Our QA Benchmarking, developed over several years in collaboration with leading pharmaceutical companies and launched in Spring 2023, is the first benchmarking that holistically and systematically evaluates the performance and maturity of QA‑related processes.

Participants receive:

  • A detailed performance and maturity assessment across all QA process fields
  • Benchmarking against QA organizations from leading pharmaceutical companies
  • Identification of key improvement opportunities
  • A personalized QA benchmarking report
  • Optional deep‑dive workshops

We evaluate your QA organization across 15 dedicated QA process fields, grouped into three categories:

  • Regulatory compliance: Inspection handling and Regulatory Affairs, assessing collaboration and interaction with regulatory agencies
  • Value‑stream related activities: Supplier Quality Management, Batch Record Review, Process Monitoring, Deviation Handling, Stability Studies, Product Quality Reviews (PQRs)
  • Internal support processes: Quality Risk Management, Training & Knowledge Management, QMS Design (incl. SOP development), and additional support functions

Each process field is assessed through a dedicated KPI set (performance) and qualitative enabler questions (maturity), enabling a holistic understanding of strengths, gaps, and successful practices. We additionally consider structural factors to define a meaningful peer group and ensure robust comparisons.

Background

The QA Benchmarking was developed together with leading pharmaceutical companies to ensure relevance and applicability. It was officially launched in Spring 2023.

The project is fully financed by participating companies. This ensures independence from individual sponsors and guarantees high practical relevance.

Data Protection

The benchmarking project is conducted in accordance with the International Benchmarking Code of Conduct, which ensures that all participants behave in a fair and responsible manner. Company data is treated with the utmost confidentiality. Company-specific information may not be used without the prior consent of the company concerned. The institute reserves the right to use the project results in summarized and anonymized form for publication.

Contact

Jessica Rebecca Helbling

Research Associate

PSCM-HSG
Büro 24-0-241
Dufourstrasse 40a
9000 St. Gallen

Alice Feldmann

Research Associate

PSCM-HSG
Büro 24-0-241
Dufourstrasse 40a
9000 St. Gallen
north