FDA Updated Benzene Usage Policy

    In month of December-2023, the FDA publish a guidance for Industry on “Reformulating drug product that contain Carbomers Manufactured ...

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Navigating an FDA Audit: Key Drawbacks to Avoid

“Life is not a bed of roses” the similar quote can be fit during inspection as “FDA Inspection may not be a bed of roses”. You have to re...

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Interview Dos and Don’ts with your Subject Matter Expert

Subject Matter Expert: When we say SMEs means Subject matter experts then we believe that he knows very well about respective subject. He c...

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Ensuring Regulatory Success: Your Roadmap to FDA Audit Readiness

Every pharmaceutical professional is immediately awake when hearing about the FDA Audit, and different types of thoughts came into his/ her ...

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What is Mean Kinetic Temperature (MKT) and how it is calculated

  What is Mean Kinetic Temperature (MKT): Mean Kinetic Temperature (MKT) is a concept used in various industries, especially in pharmaceuti...

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Different Climatic Zone in World and their Stability Storage & Testing Conditions

  The same drug and drug products may behave differently in worldwide based on their climatic zone. As we know in some of country there is t...

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