Author: 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.

Explore the critical differences between Quality Assurance and Quality Control in GMP and learn more about their role within the pharmaceutical industry.

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

Explore the critical role of analytical balances in QC labs, focusing on operational principles, performance factors, and compliance with industry standards.

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

Explore the essentials of troubleshooting peak tailing, including pro tips, and suggestions for accurate and reliable chromatography.

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.

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.