Ajay Babu Pazhayatil

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Ajay Pazhayattil is a management consultant. (ajpazha@gmail.com). He has held key management roles with brand name, generic, and contract manufacturing pharmaceutical organizations.

Articles

Solving Pharma’s Quality Unit Identity Crisis

Ajay Babu Pazhayatil

483s and Warning Letters Point to Inadequate Quality Oversight

Lessons from FDA 483s and cGMP Inspection Data

Lessons from FDA 483s and cGMP Inspection Data

Ajay Babu Pazhayatil;Naheed Sayeed;Marzena Ingram

October 2nd 2019

Production and process controls, organization and personnel were the top problems found, while packaging and labelling citations increased in 2017 and 2018.

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