by maheshbhuva | Jun 1, 2026 | Analytical Chemistry, Pharmacopea
These updates are quite significant because they reshape compliance expectations across different regions and therapeutic areas. Let me break down where the impact is most pronounced:🌍 Key Pharmacopoeia Updates- Indian Pharmacopoeia 2026 – 121 new... by maheshbhuva | May 26, 2026 | Analytical Chemistry, Audit Trail, Quality control (QC)
🚀 Building Compliant LIMS Software: Key Audit Trail FeaturesDesigning a pharmaceutical LIMS requires a relentless focus on data integrity, 21 CFR Part 11 compliance, and ALCOA+ principles. Here are the core audit trail features I’m prioritizing for our software... 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...