SQA Regulatory Surveillance Summary for Q2 2025 | Pharmaceutical Regulatory News
This edition of the pharmaceutical regulatory news summary highlights key global developments impacting pharmaceuticals, medical devices, and compliance. The update covers enforcement actions, safety alerts, and regulatory guidance issued by major health authorities including ANVISA, FDA, EMA, NMPA, MHRA, Health Canada, WHO, and others, offering timely insight into evolving regulatory expectations worldwide.
Supplier Intelligence: Turning Quality Data Into Smarter Supply Chain Decisions
As supply chains grow more complex and production pressures increase, supplier intelligence is no longer optional. Organizations that successfully convert quality data into insight, and insight into action, are better positioned to reduce escapes, improve supplier performance, and maintain operational stability.
Scaling Capacity in Aerospace & Defense: How SQA’s Field Engineering Workforce Enables High-Rate Production
Aerospace and Defense manufacturers are under pressure to increase output while maintaining the highest standards of quality, safety, and compliance. Yet growing labor and capability shortages across machining, composites, inspection, and engineering are slowing production readiness. This blog explores how SQA’s Field Engineering Workforce strengthens supplier capacity, stabilizes operations, and enables OEMs and Tier-1 suppliers to achieve high-rate production without compromising quality or regulatory requirements.
Closing the Supplier Readiness Gap: A Blueprint for Recovery, Capability Assessment, and Manufacturing Readiness
Aerospace and defense suppliers are being pushed to production rates they’ve never faced before—revealing gaps in capacity, documentation, training, and process control that can quickly threaten OEM schedules. This blog explores how a structured capability assessment provides the foundation for stabilizing suppliers, identifying readiness risks early, and accelerating recovery. By combining rapid assessments with targeted development and manufacturing readiness checkpoints, SQA offers a proven blueprint for strengthening supplier performance and supporting high-rate aerospace production.
Reducing Aerospace Escapes: The Power of Independent Source Inspection
Aerospace escapes continue to challenge production schedules and supplier performance, but most defects can be prevented long before parts reach final assembly. Independent Source Inspection, paired with risk-based planning, gives manufacturers the oversight needed to catch issues early, strengthen documentation accuracy, and reduce variability where it starts—the supplier source. By leveraging data-driven inspection depth, trained technical inspectors, and targeted oversight, aerospace teams can dramatically reduce escape rates and improve right-first-time quality across their supply chain.
Supplier Audits: Are Your Supplier Quality Audits Providing Measurable Outcomes?
Effective supplier audits are the backbone of a reliable, compliant supply chain. By strategically assessing your suppliers’, your organization can identify risk early, ensure alignment with industry standards, and strengthen every link in your supply network.
Drug Recall Updates: Regulatory Surveillance Summary – December 2019
This regulatory surveillance summary reviews key global regulatory developments from December 2019, including drug recall actions, FDA warnings, and compliance updates. By Laurel Hacche, SQA Associate United States Food and Drug Administration (US FDA) Guidances (Devices and Drugs) Device Guidance: Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings – Labeling Considerations, October 2019 This […]
Regulatory Surveillance Summary for July 2018
United States Food and Drug Administration (US FDA) Guidances Use of Electronic Health Record Data in Clinical Investigations: July 2018 US FDA has published a guidance for industry entitled Use of Electronic Health Record Data in Clinical Investigations: Guidance for Industry. The guidance provides recommendations for sponsors, clinical investigators, contract research organizations (CROs), institutional review […]
Why is Supplier Quality Important?
Imagine a customer approaching your store, a big smile on his or her face. The customer greets the doorman with a cheery “Hello!” and they exchange pleasantries. He or she enters the store, looking forward to a fulfilling trip. This person isn’t just another customer; this person is a patron who repeatedly returns to the […]
Supplier Quality Management Best Practices
To remain competitive, continuous improvement is necessary in all areas of a company. Too often, focus is kept on product development and customer service, and Supplier Quality Management is neglected after suppliers have been chosen. However, it is important to recognize the necessity of maintaining consistent standards of quality in all of the company’s current […]