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...
