Friday, July 10, 2020

SOP on Electronic Data Backup Management System

1.0 Objective To lay down a procedure for electronic data backup management system. 2.0 Scope This standard operating procedure is applicable at IT department of pharmaceutical company. 3.0...

Site Master File (SMF)

SMF (Site Master File) as the name indicates is a document that provides authentic information regarding the site of a pharmaceutical manufacturing plant. The...

Product Recall: Introduction, Classification and Recall Strategy

Product Recall: Introduction, Classification and Recall Strategy Product recall is a method of removal or correction of marketed product of a industry that does not...

SOP on Handling of Non-Conformances

1.0 Objective To lay down a procedure for handling of non-conformances. 2.0 Scope This Standard Operating Procedure is applicable for handling of non-conformances associated with product (s)...

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...

Corrective and Preventive Actions…Basic approach

Corrective and Preventive Actions CAPA is a fundamental management tool that should be used in every quality system.  This program provides a simple step by...