SOP on Quality Risk Management
1.0 Objective
To describe the procedure for management of risks, arising from different operations, activities and discrepancies.
2.0 Scope
This Standard Operating Procedure is applicable for the...
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...
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...
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...
Blinding and Re-labeling of Clinical Trial Samples for Clinical Trial purpose
1. 0 Objective
To lay down procedure for blinding and re-labeling of Clinical Trial samples for blinded Clinical Studies of the drug products.
2.0 Scope
This...
