In today’s fast-changing pharmaceutical industry, having a strong Quality Management System (QMS) is crucial. From regulatory inspections to exporting products abroad, every part of the manufacturing process must follow strict quality standards.
This newsletter shares the latest updates in pharma compliance, quality practices, and how using ERP-QMS systems can help companies organise operations, track processes, and stay compliant.
What’s New
• CDSCO issues updated Schedule M norms
India’s drug regulator has directed inspections to ensure compliance with updated Schedule M by January 1, 2026, emphasising infrastructure, equipment, and GMP aligned with global benchmarks. Small and medium pharma units (MSMEs) must comply, or risk audits and penalties.
• Industry Push for Quality Culture
At the 10th Global Pharma Quality Summit 2025, experts stressed the importance of a proactive “quality culture,” risk management, traceability, and consistent documentation, especially for global exports.
• Regulatory Oversight Tightens
Recent quality failures, such as non-compliant cough syrup batches, highlight stricter inspections and the need for robust internal QMS systems.
Why This Matters
- Regulatory deadlines are strict, and compliance is no longer optional.
- Exporters require multi-region certifications and transparent documentation.
- Firms with strong QMS processes reduce risk, improve product quality, and enhance patient safety.
- Proactive QMS helps in audits, inspections, and faster batch approvals.
QMS + ERP: How Technology Can Help
Implementing a combined QMS + ERP system can:
- Automate Quality Checks: Capture QC reports, approvals, and deviations in real time.
- Ensure Batch Traceability: Track materials, production, and finished goods for compliance and recall readiness.
- Centralize Documentation: Keep SOPs, audit trails, and regulatory records accessible and audit-ready.
- Streamline Production & Inventory: Integrate MPS/MRP, raw material usage, and inventory levels for better control.
- Manage Vendors & Suppliers: Track quality certifications and performance of suppliers in one platform.
- Improve Workflow Efficiency: Reduce manual errors, standardise processes, and enable real-time reporting.
- Support Regulatory Compliance: Facilitate adherence to CDSCO, WHO-GMP, ISO 13485, and other global standards.
How You Can Benefit
Companies adopting integrated ERP-QMS systems have reported:
- Faster batch approvals and release cycles
- Reduced manual paperwork and human errors
- Real-time quality dashboards for managers
- Improved traceability for exports and regulatory submissions
- Enhanced operational efficiency across production, sales, HR, and finance
Conclusion
A strong Quality Management System is no longer just a requirement; it’s the backbone of efficient, compliant, and high-quality pharmaceutical operations.
By combining QMS with an integrated ERP system, companies can simplify workflows, improve traceability, and ensure compliance with both local and global regulations. Staying proactive in quality management today helps safeguard your business, your products, and ultimately, patient safety.
