Articles QA What Is Good Manufacturing Practices (GMP)? 12 November 2024 gmpinsiders Good Manufacturing Practice (GMP) ensures pharmaceuticals are produced consistently with high standards for quality, safety, and efficacy, protecting patient health.
Articles Microbiology Airflow Visualization Smoke Studies (AVS) in Cleanrooms 9 June 2024 gmpinsiders Airflow Visualization Smoke Studies (AVS) ensure cleanroom compliance by visualizing airflow patterns to detect turbulence and verify unidirectional flow, critical for aseptic environments.
Articles Manufacturing QA QC Process Validation Lifecycle: Risk-Based Approach 13 March 2024 gmpinsiders Discover the essentials of Process Validation Lifecycle with a risk-based approach. Learn how to ensure product integrity from development to commercialization, meeting critical specifications.
Articles QC Residual Solvents in GMP: Classes, Guidelines and Testing 6 March 2024 gmpinsiders Explore the classes and regulatory guidelines used in Residual Solvents testing in GMP.
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 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.