Category: Drug regulatory and guidelines

Drug regulatory and guidelines Steam Sterilizer Technology

Growth in BI at Moist Heat Terminal Sterilization

By Palash Das
On

Terminal sterilization is the reliable process to assure the sterility of the product. Regulators more relay on the Moist heat terminal sterilization process than aseptic processing. In terminal sterilization product sterilized in the final container. Terminal sterilization should be utilized when the…

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Drug regulatory and guidelines

A Review Article on Visual Inspection program for sterile injectable product

By Palash Das
On

A Review Article on Visual Inspection program for sterile injectable product- A complete solution for manual inspection process

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Drug regulatory and guidelines

Get copy of 483’s, Non-compliance report and GMP certificate online from Agencies

By Palash Das
On

For companies registered with the FDA, you can check the FDA’s inspection database to see the specific firms compliance status (NAI, VAI, or OAI) – https://www.fda.gov/iceci/inspections/ucm222557.htm. I prefer starting here as it gives me a picture of their status over time. You can…

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Audit Drug regulatory and guidelines News Updates

Untouched area of Data Integrity in Pharmaceutical Industry

By Palash Das
On

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 the management…

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Audit Drug regulatory and guidelines

For Successful Inspection……… (Part I)

By Palash Das
On

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 & packaging procedures           …

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Drug regulatory and guidelines Interview & Placement News Updates

Reason for Data Integrity in pharma industry

By Palash Das
On

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, reflects how…

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Drug regulatory and guidelines Interview & Placement

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

By Palash Das
On

  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…

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Drug regulatory and guidelines

Audit readiness in Pharma industry and facing a regulatory audit

By Palash Das
On

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 auditors are…

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Drug regulatory and guidelines Interview & Placement

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

By Palash Das
On

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…

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Drug regulatory and guidelines QMS Quality Assurance

Electronic Document Management System [EDMS]

By Palash Das
On

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…

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