ICH Q7 Materials Management: Worker Safety Guide
WORKER SAFETY: ICH Q7 GMP ICH Q7 Resources and Materials Management: What Pharmaceutical Workers Need to Know If you work in an API manufacturing facility, you handle materials that go into medicines taken by real patients. ICH Q7 sets the ru
10 ICH Q7 Quality Management Tips for API Compliance
TIPS: ICH Q7 GMP Compliance 10 Practical Tips for Implementing ICH Q7 Introduction and Quality Management Requirements ICH Q7 establishes GMP requirements for active pharmaceutical ingredient manufacturing. Its opening chapters on quality man
European Vigilance for Medical Devices: Full Guide
Vigilance is the cornerstone of post-market safety oversight for medical devices in the European Union. Under Medical Device Regulation (MDR) No. 2017/745 and In Vitro Diagnostic Regulation (IVDR) No. 2017/746, manufacturers are legally required t
IVDR Compliance: A Regulatory Affairs Scenario
A regulatory affairs manager at a mid-sized in vitro diagnostics manufacturer is three weeks out from submitting a dossier to a notified body for CE marking under IVDR. During a final internal review, she notices that the device's IVDR classificat
Who Is Legally Accountable in a Change Control Failure? Quality, Operations, or Management?
In pharmaceutical and biotech manufacturing, changes to processes, equipment, or materials must be handled carefully. That’s why change control is a critical part of any company’s current Good Manufacturing Practice (cGMP) system. But when change con
CE Marking Timeline Tips: From Classification to Certification
If you’re a manufacturer looking to sell your product in the European market, CE marking is a legal must. It’s more than just a label. It shows that your product meets the European Union’s health, safety, and environmental standards.But getting that