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.
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.
News FDA Releases New Draft Guidance on Quality Considerations for Topical Ophthalmic Drug Products 3 December 2023 gmpinsiders Explore the FDA's latest draft guidance for top-notch quality in topical ophthalmic drug products. Stay informed on key considerations for eye care innovations.
Articles QA Regulatory GMP Regulatory Bodies: Understanding the Key Differences 1 December 2023 gmpinsiders Explore global GMP standards with regulatory bodies like FDA, EMA, and WHO. Ensure compliance for pharmaceutical quality and safety worldwide.
