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 | Apr 22, 2026 | Analytical Chemistry, Career, Career and Mental Health, News Pharma, Out of specification, Pharmaceutical interview,, Quality control (QC), wet lab
Finding pharmaceutical jobs outside of India requires looking at specific global platforms that specialize in life sciences. Since you have experience in Quality Control (QC), you can find many opportunities in manufacturing hubs like the USA, Europe (Germany,...
by maheshbhuva | Dec 1, 2025 | Analytical Chemistry, Out of specification, Pharmaceutical interview,, Quality control (QC)
The OOS FlowchartPhase I: Laboratory Investigation(Did the Lab make a mistake?) [ START: OOS Result Detected ] | v[ Notify Supervisor Immediately...
by maheshbhuva | Jun 1, 2024 | Analytical Chemistry, Out of specification, Quality control (QC)
Scope Input Martial In process stage Finish product Stability Note : Not applied in process stage which give procedure Further operation (e.g like give option in BMR if result not found as per Limit and further go operation e.g CF drying sample) Purpose: Ensure that...
by maheshbhuva | May 3, 2023 | 483 observation, Analytical Chemistry, Out of specification
Do we need to raise an OOS, if OOS result is observed during API Method transfer First defined which lab mean by At receiving lab At originating lab YES Required Caution: inform API vendor about failure Investigation release analysis Assess impact on DP(drug product)...
