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Validation

Validation is an important part of the pharmaceutical industry. Which provides documentary evidence that system maintains compliance in all stages.

Computer system validation (CSV) as per FDA

computerized-system-validation

What is Computer system validation? Food and Drug Administration (FDA) guidelines for software validation outlines general validation principles applicable to medical device software or software …

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7 basic factors of cleaning validation in pharma

factors-of-cleaning-validation

What are the Factors Of Cleaning Validation In Pharma? Cleaning validation is an integral part of the pharmaceutical industry and has high importance. FDA expects …

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What is validation in pharmaceutical industry?

Validation is the most important activity in the pharmaceutical industry. There are multiple types of validation in the pharmaceutical, such as Analytical Method Validation, Process …

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What are GAMP 5 Software Categories?

gamp-5-software-categories

What are GAMP 5 software categories? There are 5 software categories as per the International Society for Pharmaceutical Engineering (ISPE).  In GAMP 4 there were …

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Equipment Qualification Principles and Practices in pharma

Equipment Qualification Principles And Practices Equipment qualification is an important process for any equipment or instrument used in the pharmaceutical industry. First, need to understand …

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10 Method Validation Parameters in Pharma

validation-in-pharmaceutical-industry

Method Validation Parameters in Pharma Analytical Method validation is an essential step in the development of reference methods and in the assessment of a lab’s …

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Impact of Contamination, cross-contamination & mix-ups in Pharmaceutical

Contamination, crosscontamination and mix-ups is big challenge for pharmaceutical industry. To avoid contamination and mix-ups precautions need to take.

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