Designing a GMP Production Facility for Quality and Compliance
A Good Manufacturing Practice (GMP) production facility is not merely a building constructed; rather a system that ensures product quality, safety and compliance to regulations. GMP is extremely important in such industries as pharmaceuticals, biotechnology and nutraceuticals to safeguard consumers and ensure brand integrity.
How a GMP Compliant Facility Ensures Quality in Pharmaceutical Manufacturing
In pharmaceutical manufacturing, product quality directly impacts patient safety and therapeutic effectiveness. Regulatory authorities across the globe mandate strict adherence to Good Manufacturing Practices (GMP) to ensure medicines are safe, effective, and consistent.
CE Medical Device Regulatory Affairs: Ensuring Compliance and Market Access in Europe
The CE marking is one of the mandatory requirements of medical devices that are sold in the European Union. It implies that a medical device is in compliance with the relevant regulatory requirements of safety, performance, and quality. CE medical device regulatory affairs are very vital in providing a way forward to manufacturers in the confusing regulatory corridors to gain and sustain compliance with the regulations in Europe.
Understanding GMP Certification Requirements: A Strategic Overview
GMP certification is now a very important factor in the provision of equipment quality, patient safety and compliance with various regulations in a highly regulated pharmaceutical manufacturing environment. Good Manufacturing Practices (GMP) are not only compliance requirements, but are also a strategic framework. These requirements are fundamental to companies that want to be approved by the regulatory bodies and enjoy long-term market credibility.
USFDA ESG NextGen Update: FAERS Submission Type Removal
USFDA ESG NextGen Update: The U.S. Food and Drug Administration (FDA) is developing its regulatory submission systems under the Electronic Submission Gateway NextGen (ESG NextGen) system. There was a significant change that has been made regarding the FDA Adverse Event Reporting System (FAERS) recently. Some forms of submissions to FAERS have been eliminated and cease to be effective without delay.