Category: Interview & Placement

Pre-Use Post-Sterilization Integrity Testing (PUPSIT): A Risk-Based Approach to Implementation

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| Industrial Microbiology, Interview & Placement, Sterility Assurance, Validation

Abstract This article examines the regulatory requirements and scientific basis for Pre-Use Post-Sterilization Integrity Testing (PUPSIT) in pharmaceutical manufacturing. By evaluating the risk-benefit relationship and providing a structured assessment framework, this paper aims to guide manufacturers in making evidence-based decisions regarding PUPSIT implementation. The proposed methodology balances regulatory compliance with patient safety considerations while acknowledging […]

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Global Challenges for Indian Pharmaceutical Industry

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| Interview & Placement, News Updates, Quality Assurance, Steam Sterilizer, Validation

The Indian pharma industry is on a good growth path and is likely to be in the top 10 global markets by value by 2020. High burden of disease, good economic growth leading to higher disposable incomes, improvements in healthcare infrastructure and improved healthcare financing are driving growth in the domestic market. Pharma companies are […]

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Interview Questions for Pharmaceutical industry related jobs (QA,QC,Production,RA,f&d) for B.pharma /M.pharma (Part 11)

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| Interview & Placement

Figure: Aseptic filling operation  Assessment made based on the FDA 2004 Aseptic guidance: 1.       Initial clean room qualification includes, in part, an assessment of air quality under as-built, static conditions. A.      True                               B. False 2.       Air in the immediate proximity of exposed sterilized containers/closures and filling/closing operations would be of appropriate particle quality when […]

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Interview Questions for Pharmaceutical industry related jobs (QA,QC,Production,RA,f&d) for B.pharma /M.pharma (Part 10)

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| Drug regulatory and guidelines, Interview & Placement

  Interview for the position of manager position in QA for aseptic formulation plant: 1.  What is the interpretation between Re-Qualification and Performance re-qualification?      Re-Qualification considered with again qualify the system/equipment in terms of IQ, OQ and PQ. Performance Re-qualification means revisit or re-verification of established limit within specified periodic interval.   2. Other […]

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Complication in Pharma industry with stability issue and salary expectation in Indian scenario

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| Interview & Placement, News Updates

Now a days the pattern of interview is very interesting in pharma industry. The main argument comes with following points, Expected designation  Experience  Expected salary  Expected Stability   As we know the vertical is different from organization to organization. Normally the company followed below mention designation Trainee officer/ technical trainee: It is the initial or […]

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WEB Presentation

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| Interview & Placement, News Updates, QMS

Web presentation is an innovative idea to share pharmaceutical Knowledge, following PPT’s are updated currently  1. QRM – On Quality Risk Management  2. Make your company presentation  3. A brief review on HVAC system [youtube=https://www.youtube.com/watch?v=3UQL-J2YedE&w=320&h=266] http://www.slideshare.net/PalashDas10/slideshelf

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Interview Questions for Pharmaceutical industry related jobs (QA,QC,Production,RA,f&d) for B.pharma /M.pharma (Part 9)

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| Drug regulatory and guidelines, Interview & Placement

What is a DMF? Ans- A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. Important facts regarding DMFs It is submitted to FDA […]

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