Incident

Out of specification top  five questions and answers pharma

Can we average an OOS result with passing retest results to get a passing average? A: Absolutely not. Both FDA…

5 hours ago

Incident, Deviation,OOS,OOT describes

Detailed Breakdown ​1. Deviation ​Definition: Any departure from a written procedure, standard, or instruction. ​Types: ​Planned Deviation: A temporary, pre-approved…

6 months ago

Description of Incident<br>The High-Performance Liquid Chromatography (HPLC) sequence was interrupted unexpectedly during a scheduled run.<br>Analysis in Progress:

A sequence of 15 samples (ID: LIR-20251123-A) was being run for the quantitative analysis of [Specify Compound/Analyte] in [Specify Matrix,…

6 months ago

Which pharma Aqueous product give bring more water loss 60℅Rh OR 90℅ Rh

It's 60℅ Rh because (100 - 60 = 40 ℅ loss water (100-90 = 10 ℅ loss water Here 100…

3 years ago

(621) USP CHAPTER FOR CHROMATOGRAPHY

All chapter are use full for ADJUSTMENT of chromatography, TLC etc  In such case some questions arias that Why adjustment…

3 years ago

Interview questions and answers karl Fischer titration

Guide line935 USPType Karl Fischer titrationColoarimatry and volumetry titrationColarimatry titration because use of a electromagnetic filedVolumetric titrationThere is a manually…

3 years ago

Why only Water & Sodium Tatrate Is Use For Calibration Of Karl Fischer Titrator?

DST is primary standard and it is stable up to 150 degree Centigrade. It release free water molecules easily when…

3 years ago

How can handle unexpected events?

DIN (documents incident) IncidentDeviationOOS DIN Documentary error like miss date and sign, entry missed in logbook, Incident Like power failure,…

3 years ago