HAZOP : Hazard Operability Study
Introduction Hazard and Operability Analysis (HAZOP) is a structured and systematic technique for system examination and risk management. In particular, HAZOP is often used as…
Category: Pharma Industry Guidelines
Root Cause Analysis
Root cause analysis (RCA) is a systematic process for identifying “root causes” of problems or events and an approach for responding to them. Root cause analysis is…
Lean & Six Sigma Methodology – Basics
Lean Methodology The companies’ need for constant improvement and evolution leads to the search of management tools and methods to foster the development of customer…
SOP for Sampling
1.Objective : To lay down the procedure for sampling of intermediates, drug substances, drug products. 2. Scope : This procedure is applicable for…
Modified Approach of Lean and Six Sigma
Lean principles and Six Sigma methodologies are combined within a modified approach based on the main concept of DMAIC (Define, Measure, Analyze, Improve, Control )…
Relationship between Lean & Six Sigma
Lean and Six Sigma are the two best continuous improvement methodologies widely used by various industries. Lean is used to deliver products and services better,…
Quality Agreements – PART 2
Quality Agreement From a cGMP perspective, manufacturing activities are the most important element in a quality agreement. The most critical pieces are quality and change…
Quality Agreements – PART 1
What Is a Quality Agreement? A quality agreement is a comprehensive written agreement between parties involved in the contract manufacturing of drugs that defines and…
Internal Audits
Internal audits are a key management control activity that ensures the internal business processes are consistent. An internal audit is a form of audit process…
Design Standard Operating Procedure
How to Prepare SOP: Standard Operating Procedure (SOP) is a set of written instructions that document routine or retrospective activity. SOPs aim to achieve efficiency, quality…
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