Category: QC

Learn about all the phases of addressing Out of Specification (OOS) results in the pharmaceutical industry

Explore the essentials of cleaning validation in the pharmaceutical industry, including all necessary steps, challenges, and regulatory standards.

Look into the five key differences between OOS, OOT, and OOE results, the regulatory requirements and their importance in the GMP.

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

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…