Quality Manual
A quality manual is a document that states the company’s intentions for operating the processes within the quality management system. It can include policies for…
Tag: Quality Assurance
SOP For Line Clearance
Objective: To lay down the procedure for the line clearance of the area / equipment. 2. Scope: This SOP is applicable to all stages of manufacturing operations…
CVP : Cleaning Validation Protocol
Adequate cleaning procedures play an important role in preventing contamination & cross-contamination. Validation of Cleaning Methods provides documented evidence that an approved cleaning procedure will…
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…
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…
SOP – Planned Modification
1.Objective: To lay down the procedure for handling of Planned Modification System. 2. Scope : This SOP is applicable to addition, deletion &/or modification of…
CEHT (Clean Equipment Hold Time Study)
Why is the CEHT important for the control of a cleaning process? Essentially the reason is that nothing stays clean forever. It should be realized…
SOP: Handling of Returned Goods
1.Objective : To lay down the procedure for handling of returned goods from distributor / customer end. 2. Scope: This procedure is applicable for identifying,…
SOP-Responsibility of Quality Unit
1.Objective : To define the responsibilities of Quality Unit. 2. Scope: This procedure is applicable to all personnel working in Quality Unit. 3.Responsibilities : Quality…
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