Category Archives: Drug regulatory and guidelines

Untouched area of Data Integrity in Pharmaceutical Industry

Now a days the topic “Data integrity and non compliance” is the hot topics. Lots of references available online that deals with the Data integrity issue. One of the major example am going to give today, that can be control by … Continue reading

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For Successful Inspection……… (Part I)

Why inspection ? •      To assess & evaluate the ability of a facility to manufacture quality products which consistently meet specification and regulatory requirements. •      To confirm and assure the validity of:            Identification, traceability and integrity of lots            Manufacturing & … Continue reading

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Reason for Data Integrity in pharma industry

We know the available elements of ALCOA. We will discuss latter on the ALCOA topic. But currently we want to emphasis on the issue why we are getting this issues? Data integrity no only the problem of a specific organization, … Continue reading

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

  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 … Continue reading

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Audit readiness in Pharma industry and facing a regulatory audit

Audit is always additional headache for Pharmaceutical industry.  People from lower level to higher management are afraid for any regulatory audit. But facing of audit is not like a rocket science. As we are working for our organization same way … Continue reading

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

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 … Continue reading

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Electronic Document Management System [EDMS]

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 … Continue reading

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

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 … Continue reading

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Data Integrity Part-II (Laboratory)

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 … Continue reading

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Data Integrity -Part-I

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 … Continue reading

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