NEWS

Is Your Organisation Stuck Between R&D and GMP?

The transition from R&D to GMP does not need to represent a conflict between innovation and compliance. The most successful organisations recognise that quality systems support scientific progress. ...more

GMP

July 13, 20265 min read

Is Your Organisation Stuck Between R&D and GMP?

When does GMP actually start?

GMP does not begin at a single identifiable moment. It begins as soon as controlled processes and regulated decision-making become necessary to ensure product quality and patient safety. ...more

GMP

June 29, 20266 min read

When does GMP actually start?

Evidence & Data Integrity GLP/GCP/GMP expectations by phase

Evidence and data integrity expectations evolve progressively across GLP, GCP, and GMP environments, reflecting the increasing regulatory and patient impact of the data being generated. ...more

Quality Culture ,GMP

June 18, 20267 min read

Evidence & Data Integrity GLP/GCP/GMP expectations by phase

Preparing Quality Systems for Greater Regulatory Transparency in GMP Oversight

Regulatory transparency in Good Manufacturing Practice (GMP) oversight is entering a period of structural change, driven by increasing expectations from regulators, industry stakeholders, and the broa... ...more

GMP

June 13, 20267 min read

Preparing Quality Systems for Greater Regulatory Transparency in GMP Oversight

Organisational Training for Greater GMP Transparency

The increasing emphasis on transparency in Good Manufacturing Practice (GMP) inspection outcomes represents a structural change in regulatory expectations across therapeutic goods manufacturing, biote... ...more

GMP

June 08, 20266 min read

Organisational Training for Greater GMP Transparency

Public Consultation on Greater Transparency for GMP Inspection Outcomes

The Therapeutic Goods Administration (TGA) has commenced a public consultation on a proposal to increase transparency regarding Good Manufacturing Practice (GMP) inspection outcomes for manufacturers ... ...more

GMP

June 08, 20265 min read

Public Consultation on Greater Transparency for GMP Inspection Outcomes
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