Pharmaceuticals & Biologics

ALCOA vs. ALCOA++: Understanding Data Integrity in the Pharmaceutical Industry

ALCOA vs. ALCOA++: Understanding Data Integrity in the Pharmaceutical Industry By :Dr. Dhriti Tupe, GxP Expert ® Data integrity is the…

1 year ago

Explore 5 lucrative intellectual property career paths for science graduates. Discover how to leverage your scientific expertise in patent law, technology transfer, and IP management.

Explore 5 lucrative intellectual property career paths for science graduates. Discover how to leverage your scientific expertise in patent law,…

1 year ago

Why Risk Assessment and Mitigation Controls Reporting is Mandatory for QA and How to Handle It

Why Risk Assessment and Mitigation Controls Reporting is Mandatory for QA and How to Handle It? By :Dr. Dhriti Tupe,…

1 year ago

Cluster Development Programme (CDP) & Data Governance: Why It’s Mandatory and How to Handle It in the Pharmaceutical Industry

Cluster Development Programme (CDP) & Data Governance: Why It's Mandatory and How to Handle It in the Pharmaceutical Industry By…

1 year ago

Extractables and leachables: definitions, differences & facts

Extractables and leachables: definitions, differences & facts Extractables and leachables are contaminants that are causing biopharmaceutical manufacturers headaches, as they…

1 year ago

Visible Particles in Parenteral Drug Products: A Review of Current Safety Assessment Practice

Visible Particles in Parenteral Drug Products: A Review of Current Safety Assessment Practice Visible particles (VPs) in parenteral drug products…

1 year ago

The Role of Statistics in Clinical Trials: Safeguarding Patient Safety and Improving Healthcare Outcomes through Rigorous Evaluation of Medical Treat.

Introduction:  Clinical trials are essential for evaluating the safety and efficacy of new medical treatments. They provide a rigorous framework…

1 year ago

Why DQ, IQ, OQ, PQ Are Mandatory in Quality Assurance: Why It’s Essential and How to Handle It

Why DQ, IQ, OQ, PQ Are Mandatory in Quality Assurance: Why It’s Essential and How to Handle It? By :Dr.…

1 year ago

Cleaning Validation and Verification Reporting: A Mandatory QA Requirement

Cleaning Validation and Verification Reporting: A Mandatory QA Requirement By :Dr. Dhriti Tupe, GxP Expert ® Introduction In pharmaceutical manufacturing, ensuring…

1 year ago

Handling Elemental Impurities Risk Assessments in Pharmaceuticals

Handling Elemental Impurities Risk Assessments in Pharmaceuticals By :Dr. Dhriti Tupe, GxP Expert ® A Comprehensive Guide Elemental impurities in…

1 year ago