News ICH E6(R3) Annex 2: Draft Version for Good Clinical Practice in Modern Clinical Trials 17 November 2024 gmpinsiders
News ICH E6(R3) Annex 2: Draft Version for Good Clinical Practice in Modern Clinical Trials 17 November 2024 gmpinsiders
News USP Introduces Chapter <86> Bacterial Endotoxins Test Using Recombinant Reagents for Early Adoption 7 November 2024 gmpinsiders
Articles GDP Cold Chain Management in the Pharmaceutical Industry 27 June 2024 gmpinsiders Discover the essentials of cold chain management in pharma to ensure the safety and efficacy of temperature-sensitive products like vaccines and biologics.
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 GDP QA Regulatory Supplier Qualification in GMP – What Do You Need to Consider? 26 May 2024 gmpinsiders Learn the essential steps for supplier qualification, ensuring that suppliers meet GMP standards, mitigates risks, and maintains quality in the pharmaceutical industry.
Articles Manufacturing QA QC The Role of Batch Manufacturing Records (BMR) in GMP 12 May 2024 gmpinsiders Learn more about Batch Manufacturing Records (BMR), essential for consistent, safe pharmaceutical production and compliance with regulatory standards.
Articles Manufacturing QA QC Worst Case Selection in Cleaning Validation 31 March 2024 gmpinsiders Optimize cleaning validation in pharmaceutical manufacturing with key strategies for selecting worst-case scenarios, ensuring product safety and efficacy.
Articles GDP QA QC Temperature Mapping in GxP Environment 8 February 2024 gmpinsiders Explore essential strategies for mitigating risks in temperature-controlled environments, ensuring product stability and safety in pharmaceutical storage.
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 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 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.
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.
Articles QC Impurities in Pharmaceuticals: Types, Regulations and Strategies 17 December 2023 gmpinsiders 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…
Articles GDP Maintenance Manufacturing Microbiology QA QC Regulatory Good Documentation Practice: Ensuring Data Integrity and Compliance in the Pharmaceutical Industry 14 December 2023 gmpinsiders Explore effective strategies for maintaining clear and comprehensive records with our guide on good documentation practices, ensuring accuracy and reliability.
Articles Maintenance Microbiology QA GMP Cleanroom Classifications: Understand Class A, B, C and D 8 December 2023 gmpinsiders Learn GMP cleanroom classes A, B, C, D for contamination control in pharmaceuticals. Understand air cleanliness & particle counts for compliance.
Articles eQMS QA Electronic Quality Management Systems – eQMS 5 December 2023 gmpinsiders 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.
Articles GDP QA QC Regulatory Understanding GxP Regulations in The Pharmaceutical Industry 18 November 2023 gmpinsiders Navigate success in the pharmaceutical industry with GxP compliance. Explore GMP, GLP, GDP, and GCP for quality, safety, and regulatory excellence
News ICH E6(R3) Annex 2: Draft Version for Good Clinical Practice in Modern Clinical Trials 17 November 2024 gmpinsiders Draft ICH E6(R3) Annex 2 provides updated GCP guidelines for modern clinical trials, focusing on decentralized designs, data privacy, and participant safety.
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.
News USP Introduces Chapter <86> Bacterial Endotoxins Test Using Recombinant Reagents for Early Adoption 7 November 2024 gmpinsiders 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…
Articles QC Good Chromatography Practices – Meeting Industry Standards 5 November 2024 gmpinsiders Learn how Good Chromatography Practices enhance data integrity, ensure compliance, and boost efficiency in pharmaceutical labs for reliable, safe product outcomes.
News FDA Warning Letter: MedOffice Saglik Endustri Anonim Sirketi 3 November 2024 gmpinsiders 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…
Articles QA 10 Tips on How to Prepare for a GMP Inspection 27 October 2024 gmpinsiders Prepare for GMP inspections with these 10 tips, including audits, updated documentation, staff training, mock inspections, and setting up a war room.
Articles Manufacturing Powders, Granules, and Tablets: What is the Difference 23 October 2024 gmpinsiders Explore the key differences between powders, granules, and tablets in pharmaceuticals, including their advantages, disadvantages, and manufacturing approaches.
News Draft EDQM General Chapter 5.38: Quality of Data 21 October 2024 gmpinsiders EDQM releases draft chapter 5.38 on data quality in pharma, emphasizing standards, governance, and SME involvement.
Articles QC Out of Trend (OOT) Results in Pharma Industry 15 October 2024 gmpinsiders Learn how to detect, manage, and investigate Out-of-Trend (OOT) results in pharma to maintain product quality, ensure GMP compliance, and prevent OOS issues.
Articles QC Toxic Solvents Used in Reversed Phase Chromatography 11 October 2024 gmpinsiders Explore the impact of toxic solvents in Reversed Phase Chromatography, their risks, and eco-friendly alternatives to ensure safe, accurate testing in pharmaceutical QC labs while minimizing environmental hazards.