Sunday, January 20, 2019

In-Process Checks (Stage – Dry Syrup Packing)

In case of In-process during stage of packing weight check is very important, following are the procedure for the same: Collect one bottle...

Corrective and Preventive Action (CAPA)

1.0 Objective To lay down a procedure for the Corrective and Preventive Action so as to eliminate the causes of potential non-conformities and /or encountered...

SOP for Code to Code Transfer of Materials and Additional Testing of Materials /...

Objective To lay down a procedure for code transfer of same material from one code to another and to carry out additional testing of APIs,...

TSE & BSE Risk and Regulation in Pharmaceuticals

Risk & Regulations of TSE/BSE in pharmaceuticals are of great importance because of its irreversible fatal effects on human health. Before knowing the risk...

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 Repackaging / Re-labeling of Finished Goods

1.0 Objective To lay down a procedure for Repackaging / Re-labeling of Finished Goods. 2.0 Scope The scope of this standard operating procedure is applicable for Finished...

Introduction to Water for Pharmaceutical Purpose

Water is an integral part of human body; likewise it is also inseparable when it comes to pharmaceutical industry.  It as an essential raw...

Hold Time Study …..current approach

Hold Time Study Approach...... It is an expectation of regulatory organizations that companies establish and monitor clean and dirty equipment hold times for manufacturing equipment...

How to Write a Validation Protocol?

A protocol is a written statement to conduct the validation process along with the procedure, test method, equipment handling, specifications, acceptance criteria, report and...

SOP On Facility Designing and Qualification

1.0 Objective To define the Standard Operating Procedure for Facility Designing and Qualification. 2.0 Scope 2.1 This SOP is applicable for pharmaceutical Facilities. 2.1.1 When designing new facility. 2.1.2...