Saturday, April 20, 2024

SOP on Pest & Rodent Control

1.0 Objective To lay down the procedure to control pest & rodent within the plant. 2.0 Scope This SOP is applicable for pest & rodent control within...

SOP on Status Labeling System and Its Control

1.0 Objective: To lay down a procedure for the status labeling system and its control. 2.0 Scope: This Standard Operating Procedure is applicable for identification...

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)...

Technology Transfer Sample Protocol in Pharmaceuticals

In the pharmaceutical industry, “technology transfer” refers to the processes that are needed for successful progress from drug discovery to product development to clinical trials to...

Sampling of Inprocess Materials and Finished Products

1.0 Objective To lay down a procedure for Sampling of Inprocess materials and Finished products. 2.0 Scope This standard operating procedure is applicable to pharmaceutical formulation plant...

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...

Quality Audit: Introduction, Types and Procedure

Quality Audit: Introduction, Types and Procedure Auditing in simple terms could be defined as inspection of a process or a system to make sure that...

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...

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...