Month: September 2020

Procedure for Handling of Mock Recall


1.0Objective : To lay down the procedure for conducting Mock Recall.2.0Scope : Scope of this document is to follow procedure for Mock Recall.3.0Responsibility :3.1Quality Assurance Department for conducting, monitoring and administration of Mock Recall procedure.4.0Definition(s) of Mock Recall: Mock recalls are routine exercises conducted by manufacturers, processors, distributors and other various trading partners in the supply chain to … Continue reading Procedure for Handling of Mock Recall

Procedure for Trend Analysis


Objective : To lay down a Procedure for Trend Analysis.   Scope : The scope of this document is to provide the Procedure for Trend Analysis of but not limited to Water analysis results, Environmental monitoring results, in Quality Control Department.    Responsibility :      Quality Control Personnel  :       To prepare the trends of results.      To review … Continue reading Procedure for Trend Analysis

Control Sample Management in Pharmaceuticals


What is Control Sample: An appropriately identified sample that is representative of each batch that shall be retained is known as control sample. These are also referred as retention or reserve sample. Control samples shall be collected for Finished Product, Raw Material and Packing Materials. Why Control Sample shall be collected: As per regulatory and … Continue reading Control Sample Management in Pharmaceuticals