Ajay Pazhayattil

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Articles

Assessing Biomanufacturing Process Robustness

Assessing Manufacturing Process Robustness

Ajay Pazhayattil;Sanjay Sharma;Amol Galande;Marzena Ingram;Robert Rhoades
July 1st 2021

A structured assessment process can determine compliance to lifecycle process-validation requirements for biopharmaceuticals.

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Solving Pharma’s Quality Unit Identity Crisis

Ajay Pazhayattil
July 1st 2020

483s and Warning Letters Point to Inadequate Quality Oversight

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Quality Metrics and CMO Agreement

Naheed Sayeed-Desta;Ajay Pazhayattil;Jana Spes
May 15th 2017

FDA’s focus on the quality culture and its request for quality metrics may ensure a successful company-CMO relationship.

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