Tuesday, February 20, 2018

SOP on Failure Mode and Effect Analysis and Root cause Analysis

1.0 Objective To provide a guideline for conducting “Failure Mode and effect Analysis” and “Root Cause Analysis”. 2.0 Scope This SOP is applicable in equipment / process...

SOP on Receipt of Raw Materials and Packaging Materials

1.0 Objective: To lay down a procedure for receiving the raw materials and packaging materials. 2.0 Scope: This SOP is applicable for receipt of Raw and Packing...

What is Calibration, Verification and Validation in pharmaceuticals?

In pharmaceutical industries these three terms are commonly used. Sometimes there is a confusion between these terms. Here I would like to explain these...

“Life cycle Approach to Process Validation” – Current Regulatory perspective & It’s Benefits

“Quality has to be built-in into the process and cannot be relied on the testing of final product” “Process Validation (PV)” concept in pharmaceutical industry...

Testing of Primary Packaging Materials

1.0 Objective To lay down a procedure for Testing of Primary Packaging Materials. 2.0 Scope This Standard Operating Procedure is applicable pharmaceutical formulation plant. 3.0 Responsibility QC- officer...