Wednesday, November 22, 2017

Annual Product Quality Review (APQR)

"APQR is a Annual Product Quality Review somewhere known as APR (Annual Product Review)" APQR contains a documented evidence oriented review of all activities related...

SOP on Quality Management Review

1.0 Objective To lay down a procedure for Quality Management Review. 2.0 Scope This procedure is applicable at pharmaceutical formulation plant.  The objective of Quality Management...

Quality By Design and It's Essential Elements

FDA has taken initiatives to enrol the sound scientific principles that involve prior identification of the loop poles in the manufacturing and operating procedures...

Difference between Corrective and Preventive Actions……..CAPA

Corrective Action: A corrective action is a reaction to a problem that has already occurred. It assumes that a nonconformance or problem exists and has been...

Overview of Root Cause Analysis Techniques….!!!

Overview of Root Cause Analysis Techniques What is a Root Cause Analysis? A root cause analysis is a means to get to the bottom of...

Corrective and Preventive Action

Occurrence of problems in any business have impact on the financial conditions of a company. Therefore every Pharmaceutical Industry is focusing on troubleshooting problems,...

Differences between FMEA & RCA

Sr. No. FMEA (Failure Mode and Effect Analysis) RCA (Root Cause Analysis) 1 Prospective, Proactive Focus : Failure prevention Reactive Focus : Failure detection 2 Used for changes or modification in equipment, process Used for...