FDA Draft Guidance: Considerations for Complying with 21 CFR 211.110
FDA's January 2025 draft on 21 CFR 211.110 outlines CGMP measures for batch uniformity, drug integrity, and advanced manufacturing innovation
FDA Highlights Systemic Issues at Mylan Laboratories in Recent Warning
FDA warns Mylan Laboratories for critical cGMP violations in quality control, data integrity, and governance, urging urgent corrective actions to ensure compliance.
Flow Properties of Powders and Granules in Pharma Industry
Explore the flow properties of powders and granules in pharma manufacturing. Learn key factors, metrics, and methods ensuring product consistency and efficiency.
How to Write a Compliant SOP in the Pharma Industry?
Learn how to write SOPs in the pharmaceutical industry. A step-by-step guide on structure, best practices, and ensuring GMP compliance for operational efficiency.
FDA Transitional Enforcement Guidance for Ethylene Oxide Sterilization Facility Changes for Class III Devices
FDA announces a new policy on ethylene oxide sterilization site changes for Class III devices, ensuring supply chain stability and patient safety.
Stability Storage Conditions in Pharma Industry
Learn about stability storage conditions in pharma, including long-term, intermediate, and accelerated studies, climatic zones, regulatory guidelines, and strategies for preserving drug quality, safety, and efficacy across diverse environments.
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 participant safety.
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.
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.
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 outcomes.