In this SOP we will explain the Aseptic Filling Process Validation Media Fill Trial. 1. PURPOSE To ensure that aseptic manufacturing, filling techniques or practices being used are capable of producing the sterile products. 2 .SCOPE It is applicable to the injectable area of the Production Department. 3. RESPONSIBILITY Quality Assurance officer Section Production Officer […]
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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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In this article, we will discuss HVAC System Validation.HVAC Validation is required for pharmaceutical cleanroom validation. following tests are performed for validation. 1.0 Air Flow Pattern 1.1 Take the titanium tetrachloride stick. 1.2 Burn the stick. 1.3 Place the burning stick in front of the running Air Handling Unit (AHU). 1.4 Observed the flow of […]
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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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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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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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