The quantitative study investigated factors that influence the initiation, the convergence
prospects, the highest return on investment sector, and the variables that can delay machine …

The paper introduces evaluation methodologies and associated statistical approaches for
process validation lifecycle Stage 3A. The assessment tools proposed can be applied to newly …

This paper describes a pragmatic approach that can be applied in assessing powder blend
and unit dosage uniformity of solid dose products at Process Design, Process Performance …

This paper introduces an innovative risk assessment tool, a semiquantitative risk determination
(SQRD) method designed to address risk on the operational and organizational level …

Solid dose pharmaceutical drug manufacturing process validation has evolved since
introduction of the first FDA guidance in 1987. The current thinking on process validation reflects …

The commissioning and qualification approach for biopharmaceutical manufacturing
equipment has been an established process for decades. The risk-based approach categorizes …

The purpose of this study was to determine if any correlations could be identified from the
form 483 observations issued by the US FDA during routine GMP inspections of drug …

… Ajay Babu Pazhayattil, has been providing strategic direction and leadership is his roles
with brand, generic/biosimilar, and CDMO organizations. He is an industrial pharmacist …

… Ajay Babu Pazhayattil has held key management roles with brand name, generic, and
contract manufacturing organizations. He is an industrial pharmacist successful in delivering …

… This applied dissertation was constructed and submitted by Ajay Babu Pazhayattil under
the direction of the committee listed below. It was submitted to the School of Business and …