by maheshbhuva | May 20, 2026 | Analytical Chemistry, Out of specification, Pharmaceutical interview,, Quality control (QC)
Can we average an OOS result with passing retest results to get a passing average? A: Absolutely not. Both FDA and MHRA guidelines strictly prohibit averaging an OOS result with passing retests to “hide” the failure or bring the batch into compliance....
by maheshbhuva | May 19, 2026 | Analytical Chemistry, Documents error (DIN), GMP, ICH Guideline, Out of specification, Pharmaceutical interview,, QMS, Quality control (QC)
An Out of Specification (OOS) investigation is a critical regulatory requirement in the pharmaceutical industry. When an analytical result falls outside the established specifications or acceptance criteria (defined in pharmacopoeias, drug applications, or internal...
by maheshbhuva | May 16, 2026 | Hplc, Hplc column, HPLC VIAL, Job interview, Pharmaceutical interview,, Quality control (QC)
In the competitive landscape of modern pharmaceutical companies, ensuring precise product quality isn’t just a regulatory requirement—it is the foundation of patient safety. At the heart of this quality assurance is HPLC analysis (High-Performance Liquid...
by maheshbhuva | May 16, 2026 | Analytical Chemistry, GMP, Quality control (QC)
Duplicate raw material samples is critical for maintaining data integrity, ensuring cGMP compliance, and optimizing laboratory workflow efficiency. Duplicate samples often occur due to manual entry errors, mislabeling, or poor communication between the warehouse...
