QMS

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

Laboratory Incident Report

Incident Number: LAB-2025-012 Date of Incident: December 19, 2025 Product Name: Azithromycin (Finished Product) Batch Number: 33334562222 Test: Related Substances…

5 months ago

Specificity analytical method validation

According to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guideline Q2(R1), specificity is…

1 year ago

21 cfr

21 CFR stands for Title 21 of the Code of Federal Regulations. It is a set of regulations issued by…

3 years ago

Difference class A and class b glassware use in laboratory

The terms "Class A" and "Class B" are commonly used to describe different types of glassware in laboratory settings, particularly…

3 years 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

Type of buffer in Hplc

Phosphate buffer Citrate buffer Formate buffer Acetate buffer Tris(hydrixymethyl) -aminomethane Phosphate buffer Pka 2.1 Ph range 1.1 tob3. 1 Pka…

3 years ago

According USP Chapter 621 : Adjustment of Mobile Phase

Adjustment of Mobile Phase Adjustment in composition of the mobile phase Adjustment ph of the aqueous component of the mobile…

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