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.
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 […]
Steps to Improve Supplier Quality
To uphold the strongest business model possible, companies can implement the Japanese idea of Kaizen, or, the principle of continuous improvement across all areas of a company. But businesses often choose to focus resources on certain areas. In turn, some areas of the business model may be inadvertently neglected. For instance, have you recently examined […]
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 […]
5 Secrets to Superior Supplier Quality Management
We know that supplier quality management includes ensuring that raw materials and supplies arrive on time and meet quality requirements. A great way to achieve business results, and exceed them, is to work with a supplier that understands the care that goes into your business. When you manage supplier quality management effectively, you can surpass […]