Tag: sterility

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)

3 Comments
| 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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Electronic Document Management System [EDMS]

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| Drug regulatory and guidelines, QMS, Quality Assurance

Like procedures, protocols, methods, and specifications, documents provide instructions to perform tasks and make decisions safely, effectively, compliantly, and consistently. Records such as batch manufacturing records, cleaning logs and laboratory data sheets and notebooks provide evidence that actions were taken and decisions were made in keeping with procedures and GMP expectations. Reports are yet another […]

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Data Integrity (Part-III) (Some Major Observations)

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| Drug regulatory and guidelines, QMS, Quality Assurance

Observation 1 Failure to maintain complete data derived from all laboratory tests conducted to ensure compliance with established specifications and standards The firm inspected lacked accurate raw laboratory data records for batches of API that were shipped. The inspection revealed that batch samples were retested until acceptable results were obtained. In addition, Quality Control (QC) […]

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Data Integrity Part-II (Laboratory)

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| Drug regulatory and guidelines, QMS, Quality Assurance

Most companies have experienced being audited and, where necessary, “defending” the work carried out in their analytical laboratories during audits. Historically, laboratories have tended to provide information about the validation of their methods and procedures, the qualification and suitability of their analytical equipment, and information about training of their laboratory staff as justification for the […]

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Data Integrity -Part-I

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| Drug regulatory and guidelines, QMS

The basic rules in any good manufacturing practice (GMP) regulations specify that the pharmaceutical manufacturer must maintain proper documentation and records. Documentation helps to build up a detailed picture of what a manufacturing function has done in the past and what it is doing now and, thus, it provides a basis for planning what it […]

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