GMP Insiders

Discover the essentials of cold chain management in pharma to ensure the safety and efficacy of temperature-sensitive products like vaccines and biologics.

Airflow Visualization Smoke Studies (AVS) ensure cleanroom compliance by visualizing airflow patterns to detect turbulence and verify unidirectional flow, critical for aseptic environments.

Learn the essential steps for supplier qualification, ensuring that suppliers meet GMP standards, mitigates risks, and maintains quality in the pharmaceutical industry.

Learn more about Batch Manufacturing Records (BMR), essential for consistent, safe pharmaceutical production and compliance with regulatory standards.

Optimize cleaning validation in pharmaceutical manufacturing with key strategies for selecting worst-case scenarios, ensuring product safety and efficacy.

Explore essential strategies for mitigating risks in temperature-controlled environments, ensuring product stability and safety in pharmaceutical storage.

Explore the crucial role of pharmacovigilance in ensuring medication safety, from detecting adverse effects to proactive risk management.

Explore the crucial roles of Design Review and Design Qualification in the pharmaceutical industry, ensuring equipment meets user needs and complies with rigorous standards.

Explore best practices in environmental monitoring for pharmaceutical cleanrooms, ensuring sterility and safety with comprehensive guidelines and tips.

Explore the essentials of Quality Risk Management in Pharma: Principles, tools, guidelines, and implementation strategies for enhanced safety.

Explore the essentials of User Requirement Specification (URS) for successful project execution. Learn to craft effective URS documents.

Discover the essential information about impurities in pharmaceuticals, their types, and how they impact drug quality. Learn about regulatory requirements, testing strategies, and the importance of analytical methods in ensuring…

Explore effective strategies for maintaining clear and comprehensive records with our guide on good documentation practices, ensuring accuracy and reliability.

Learn GMP cleanroom classes A, B, C, D for contamination control in pharmaceuticals. Understand air cleanliness & particle counts for compliance.

Optimize compliance and quality control in the pharmaceutical industry with eQMS (Electronic Quality Management System). Streamline documentation, enhance regulatory adherence, and elevate overall product quality.

Navigate success in the pharmaceutical industry with GxP compliance. Explore GMP, GLP, GDP, and GCP for quality, safety, and regulatory excellence

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 announces a new policy on ethylene oxide sterilization site changes for Class III devices, ensuring supply chain stability and patient safety.

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.

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

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

The United States Pharmacopeia (USP) has released  Chapter <86> Bacterial Endotoxins Test Using Recombinant Reagents for early adoption, outlining using non-animal-derived reagents in bacterial endotoxin testing. The guidelines are part…

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

he FDA inspection at MedOffice Saglik Endustri Anonim Sirketi revealed significant CGMP violations that could jeopardize product quality and consumer safety. Issues ranged from inadequate testing of drug products to…

Prepare for GMP inspections with these 10 tips, including audits, updated documentation, staff training, mock inspections, and setting up a war room.

Explore the key differences between powders, granules, and tablets in pharmaceuticals, including their advantages, disadvantages, and manufacturing approaches.