📌 Case Study: Sandoz Canada (2012) – Supply Shortages due to GMP Non-Compliance

Background

• Company: Sandoz Canada, a division of Novartis

• Year: 2012

• Issue: Nationwide shortage of injectable drugs in Canada and USA

• Cause: Non-compliance with Good Manufacturing Practices (GMP) at the Sandoz Boucherville, Quebec plant.

Key Events

1. FDA & Health Canada Inspections

   • The FDA and Health Canada identified quality and compliance deficiencies at the Boucherville plant.

   • GMP violations included: inadequate sterility assurance, poor documentation practices, and quality system failures.

2. Production Slowdown

   • To address deficiencies, Sandoz voluntarily slowed or halted production of certain sterile injectable drugs.

   • This caused a massive supply shortage across North America.

3. Healthcare Impact

   • Hospitals faced critical shortages of injectable painkillers, antibiotics, and anesthetics.

   • Medical associations raised alarms about risks to patient care.

4. Public and Government Reaction

   • Canadian hospitals relied heavily on Sandoz as a major supplier, exposing over-dependence on a single source.

   • The federal government was criticized for lack of contingency planning.

Root Cause Analysis

• Inadequate GMP compliance: Sterile drug manufacturing standards not met.

• Weak Quality Management System (QMS): Lack of preventive actions and poor deviation handling.

• Over-reliance on single supplier: Hospitals had no immediate alternatives.

Corrective and Preventive Actions (CAPA)

• Remediation Plan: Investment in upgrading facilities and quality systems.

• Increased Oversight: Health Canada and FDA imposed stricter monitoring.

• Diversification of Supply: Governments and healthcare institutions began exploring multiple suppliers to avoid recurrence.

Lessons Learned

1. Strict GMP compliance is critical in sterile drug manufacturing.

2. Supplier risk management is necessary to avoid nationwide shortages.

3. Regulatory vigilance protects patient safety but may cause short-term disruptions.

4. Transparent communication between industry, regulators, and healthcare providers is essential during shortages.