Process validation in pharmaceutical industry

In this article, we will discuss process validation in the pharmaceutical industry(Alvamax Drench).    Objective: To conduct the process validation of the manufacturing process for the Alvamax 100 Drench manufactured at the Vetlab(Pvt) Ltd(liquid section). The Validation study shall be conducted for the generation of sufficient data to establish documentary evidence and to provide assurance […]

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HVAC System Validation Reports

HVAC VALIDATION/TEST REPORT   Sr # Parameters Results 1 Area of room  (cubic ft) 2 Req CFM 3 Req. No of air changes 4 Air velocity (ft/min 5 Grill size (sq.ft 6 Required Temp 7 Req Humidity 8 Room Pressure     Particle Count: Test Apparatus /Method: particle counter: __________________________________________________ Viable monitoring: Test Apparatus /Method: […]

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clean steam

Clean Steam Validation

In this article, we will discuss the Clean Steam Validation procedure using in pharmaceutical sterile manufacturing. A sampling of Pure steam for Bacterial Endotoxin Testing & Viable Count Samples for Bacterial endotoxin evaluation should be collected in dehydrogenated tubes/bottles. Remove the cap from the bottle immediately prior to obtaining a sample. While samplings avoid direct […]

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Analytical Method validation of Drench

1.0 Method Validation: Analytical method validation is the process to confirm that the analytical procedure employed for a specific test is suitable for its intended use. 2.0 Objective: Analytical monitoring of a pharmaceutical product is necessary to ensure its efficacy throughout all phases of its shelf life; such monitoring is in accordance with the specifications […]

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