QUALITY BY DESIGN AND SCALE – UP Unit Operations Unit operations are the individual basic …
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Working Principle of Auto Coater Machine
Working Principle of Auto Coater Machine The film to be coated on the tablet is …
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Cleaning & sanitization of Classified & Clean area
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Sanitizing the clean rooms
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Cleaning-in-Place (CIP) systems
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Pseudoephedrine & Mechanism of Action
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GMP Inspection Checklist & Most frequently asked questions about HPLC
GMP Inspection Checklist & Most frequently asked questions about HPLC HPLC is an abbreviation for …
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Water Analysis as per IP/BP/USP
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HPLC troubleshooting
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Reference Standard and Working Standards
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HPLC Interview Questions
Recent Posts
May, 2023
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8 May
Root Cause Analysis In Pharmaceuticals
Root Cause Analysis In Pharmaceuticals (RCA) RCA is a systematic process to identify the causal factors that contributed to the occurrence of a harmful event. RCA focuses primarily on systems and processes, not individual performance. Finding and identifying root causes during an investigation adds considerable value by pointing out significant …
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7 May
Performance qualification protocol cum report
Performance qualification protocol cum report shall consist of minimum contents but not be limited to TITLE Pre Approval Overview Purpose Background Responsibility Requalification System Description Performance Qualification Procedure Training Date Performance Qualification Results for Run-1 Performance Qualification Results for Run -2 Performance Qualification Results for Run-2 Deficiency (if any) and …
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7 May
Operation cum performance qualification protocol cum report
Operation cum performance qualification protocol cum report shall consist of minimum contents,but not limited to. TITLE Pre Approval Overview Purpose Background Responsibility Requalification System Description Operational Qualification Procedure Training Date Calibration Review Key Functionality Safety Features SOP verification Preventive maintenance procedure verification Operational testing Performance Qualification Results Deficiency (if any) …
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7 May
Cleaning validation
Cleaning validation consists of the following:- Protocol No. for cleaning, validation should be written in the format PRT/CLV/ CC/DD.PRT refers to protocol, CLV refers to cleaning validation, and CC refers to Protocol no. DD refers to revision no. of the protocol. Revision No. of the protocol goes through the proper …
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7 May
Operational qualification protocol cum report
Operational qualification protocol cum report shall consist of minimum contents but not limited to. Overview Purpose Background Responsibility Requalification System Description Operational Qualification Procedure Training Date Calibration Review Key Functionality Safety Features SOP verification Preventive maintenance procedure verification Operational testing Deficiency (if any) and Corrective Action Report Acceptance criteria Summary …
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