Category: QC

The Quality Control (QC) category covers the testing and analytical activities that confirm the quality of raw materials, intermediates, and finished products before release. QC is one of the key pillars of GMP, ensuring products consistently meet defined specifications.

Topics include method validation and verification, stability studies, impurity profiling, chromatography, sampling, calibration, and laboratory data integrity, with a focus on practical execution and inspection-ready documentation.

If you don’t find what you are looking for, try using a different term or contact us.

Articles, QC, Regulatory

December 23, 2023

Defining Specification Limits for Impurities in New Drug Products

Learn how pharmaceutical manufacturers define specification limits for known, unknown, and total impurities in new drug products, ensuring safety and...

Articles, QC

December 17, 2023

Impurities in Pharmaceuticals: Types, Regulations and Strategies

Discover the essential information about impurities in pharmaceuticals, their types, and how they impact drug quality. Learn about regulatory requirements,...