SOP on Calibration of Weighing Balance
1.Purpose: To lay down the procedure for the calibration of weighing balances. 2. Scope: Applicable to all weighing balances except analytical balances. 3. Responsibility: Department…
Category: Pharma Industry Guidelines
Near Miss
Near Miss A Near Miss is an unplanned event that did not result in an injury or property damage but had the potential to do so. Near…
Analytical Method Validation
Method validation is the process used to confirm that the analytical procedure employed for a specific test is suitable for its intended use. Results from method validation can be used…
Audit Process
Vendor is an individual or company that sells goods or services to someone else in the economic production chain. An audit is a independent, systematic…
“5 Whys” Technique – An Investigation Tool
The Five Whys Technique is a simple problem-solving technique that helps to get to the root of a problem quickly only by asking “Why?” five times…
Quality Policy
Quality Policy A quality policy is a brief statement that aligns with your organization’s purpose and strategic direction, provides a framework for quality objectives, and includes a commitment to…
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…
IQ Protocol
Installation Qualification is defined as, establishing by objective evidence that all key aspects of the process equipment and ancillary system installation adhere to the manufacturer’s…
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…
Validation Lifecycle
Validation lifecycle approach is linking product and process development, validation of the commercial manufacturing process and maintenance of the process in a state of control…
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