Articles Regulatory Pharmacovigilance – Ensuring the Safety of Medications 23 January 2024 gmpinsiders Explore the crucial role of pharmacovigilance in ensuring medication safety, from detecting adverse effects to proactive risk management.
Articles QC 5 Key Differences Between OOS, OOT and OOE Results 20 January 2024 gmpinsiders Look into the five key differences between OOS, OOT, and OOE results, the regulatory requirements and their importance in the GMP.
Articles Maintenance Design Review and Design Qualification in the Pharmaceutical Industry 17 January 2024 gmpinsiders Explore the crucial roles of Design Review and Design Qualification in the pharmaceutical industry, ensuring equipment meets user needs and complies with rigorous standards.
Articles QA QC Quality Assurance vs. Quality Control in GMP: Key differences 11 January 2024 gmpinsiders Explore the critical differences between Quality Assurance and Quality Control in GMP and learn more about their role within the pharmaceutical industry.
Articles Microbiology Best Practices for Environmental Monitoring in the Pharmaceutical Industry 7 January 2024 gmpinsiders Explore best practices in environmental monitoring for pharmaceutical cleanrooms, ensuring sterility and safety with comprehensive guidelines and tips.
Articles QC Analytical Balances for QC Labs Purposes: Proper Weighing Practices 4 January 2024 gmpinsiders Explore the critical role of analytical balances in QC labs, focusing on operational principles, performance factors, and compliance with industry standards.
Articles Manufacturing QA QC Quality Risk Management in the Pharmaceutical Industry 2 January 2024 gmpinsiders Explore the essentials of Quality Risk Management in Pharma: Principles, tools, guidelines, and implementation strategies for enhanced safety.
Articles QC Peak Tailing in Chromatography: Troubleshooting Basics 29 December 2023 gmpinsiders Explore the essentials of troubleshooting peak tailing, including pro tips, and suggestions for accurate and reliable chromatography.
Articles QC Regulatory Defining Specification Limits for Impurities in New Drug Products 23 December 2023 gmpinsiders Learn how pharmaceutical manufacturers define specification limits for known, unknown, and total impurities in new drug products, ensuring safety and quality compliance with ICH Q3B (R2) guidelines.
Articles Maintenance Manufacturing QA QC User Requirement Specification: How to Create URS for Successful Equipment Procurement 20 December 2023 gmpinsiders Explore the essentials of User Requirement Specification (URS) for successful project execution. Learn to craft effective URS documents.