Learn about stability storage conditions in pharma, including long-term, intermediate, and accelerated studies, climatic zones, regulatory guidelines, and strategies for...

News, Regulatory Updates

November 17, 2024

ICH E6(R3) Annex 2: Draft Version for Good Clinical Practice in Modern Clinical Trials

Draft ICH E6(R3) Annex 2 provides updated GCP guidelines for modern clinical trials, focusing on decentralized designs, data privacy, and...

Articles, QA

November 12, 2024

What Is Good Manufacturing Practices (GMP)?

Good Manufacturing Practice (GMP) ensures pharmaceuticals are produced consistently with high standards for quality, safety, and efficacy, protecting patient health....

News, Regulatory Updates

November 7, 2024

USP Introduces Chapter <86> Bacterial Endotoxins Test Using Recombinant Reagents for Early Adoption

USP releases early adoption guidelines for non-animal endotoxin testing, promoting sustainable recombinant Factor C methods with strict validation standards....

Articles, QC

November 5, 2024

Good Chromatography Practices – Meeting Industry Standards

Learn how Good Chromatography Practices enhance data integrity, ensure compliance, and boost efficiency in pharmaceutical labs for reliable, safe product...

News, Warning Letters

November 3, 2024

FDA Warning Letter: MedOffice Saglik Endustri Anonim Sirketi

he FDA inspection at MedOffice Saglik Endustri Anonim Sirketi revealed significant CGMP violations that could jeopardize product quality and consumer...

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Month: November 2024

Stability Storage Conditions in Pharma Industry

ICH E6(R3) Annex 2: Draft Version for Good Clinical Practice in Modern Clinical Trials

What Is Good Manufacturing Practices (GMP)?

USP Introduces Chapter <86> Bacterial Endotoxins Test Using Recombinant Reagents for Early Adoption

Good Chromatography Practices – Meeting Industry Standards

FDA Warning Letter: MedOffice Saglik Endustri Anonim Sirketi

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