Category Archives: quality assurance

Global Challenges for Indian Pharmaceutical Industry

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 … 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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Management of Corrective and Preventive Action (CA-PA)

The concept of Corrective and Preventive Action (CAPA) has doesn’t specifically appear in the older version of Good Manufacturing Practices. CAPA seems to have become popular in the pharmaceutical industry because of its use with medical devices.[ISO 13495:2003 and the … Continue reading

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Popular methods of Risk Assessment (Part-II)

Fault tree analysis The fault tree analysis (FTA) was first introduced by Bell Laboratories and is one of the most widely used methods in system reliability, maintainability and safety analysis. It is a deductive procedure used to determine the various … Continue reading

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Popular methods of Risk Assessment (Part I)

Failure Mode Effects Analysis (FMEA) Failure modes and effects analysis (FMEA) is a step-by-step approach for identifying all possible failures in a design, a manufacturing or assembly process, or a product or service. “Failure modes” means the ways, or modes, … Continue reading

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Acceptance Quality Level for Packaging Material and Printed Packaging Material

Definitions:AQL: The AQL is the maximum percentage defective (or the maximum number of defects per hundred units) that can be considered satisfactory as a process average.Nonconformity : Non fulfillment of a specified requirementDefect: Non fulfillment of an intended usage requirement Nonconforming … 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 6)

Few basic question ask during interview of fresher candidates (B.pharma /M.pharma) in HR round, so get ready and be prepared for interview  1.      What is your aim in life?    2.      Who has inspired you in your life and why?    3.      … Continue reading

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Qualifying Disinfection for Critical Environments and Cleanrooms

How are Disinfection Qualification Studies Regulated? The success of disinfection procedures used in an aseptic manufacturing environment and the qualification of such processes to complying with GMP’s are not detailed in a simple guidance document. Although there is no harmonized … Continue reading

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