General GxP Requirements – GLP, GCP, and GMP

General GxP Requirements – GLP, GCP, and GMP

Quality Systems Now
Published on: 18/10/2025

GLP, GCP, and GMP form the backbone of GxP requirements in the life sciences sector. While each framework has a distinct focus—laboratory studies, clinical trials, and manufacturing—they share core principles.

GMP
Public Feedback sought on updates to Good Manufacturing Practice (GMP) Guidelines

Public Feedback sought on updates to Good Manufacturing Practice (GMP) Guidelines

Quality Systems Now
Published on: 08/10/2025

The Therapeutic Goods Administration (TGA) has opened public consultation on proposed updates to the Good Manufacturing Practice (GMP) guidelines that regulate the manufacture of therapeutic goods in Australia.

GMP
ISO 14971: Application of Risk Management to Medical Devices

ISO 14971: Application of Risk Management to Medical Devices

Quality Systems Now
Published on: 21/09/2025

ISO 14971: Application of Risk Management to Medical Devices

Quality CultureGMP
Navigating the Release for Supply (RFS) Process Effectively

Navigating the Release for Supply (RFS) Process Effectively

Quality Systems Now
Published on: 07/09/2025

Navigating the Release for Supply (RFS) Process Effectively

GMP