BK Chakravarthy*

Capic Laboratories Private Limited, Hyderabad, India

*Corresponding Author: BK Chakravarthy, Capic Laboratories Private Limited, Hyderabad, India.

Received: February 22, 2018; Published: March 22, 2018

Citation: BK Chakravarthy. “Impurity Profile Validations of API- Challenges for GMP Inspection-Part 1”. Acta Scientific Pharmaceutical Sciences 2.4 (2018).

Abstract

  Impurity profile validations test the competence of GMP auditors as impurities are added up at various stages of new routs of synthesis of API manufactured in different manufacturing units (done when different from the original R&D routes and conditions). Hence there is a need for more focused audits and key role to be played by GMP auditors in the validations of impurity profiles. GMP auditors should examine critically for batch to batch aberrations and their views not only can provide substantial inputs for the audited company’s research team for critical evaluations but also prevent many potential and time tested API being sidelined due to newly attributed clinical toxicity reported for API’s manufactured by synthetic routes other than original research done at the stages of commercial launch of API’s. There are no reports available for such new research findings if any newly added impurities due to changes made in synthesis route to reduce cost or process time and perhaps some new impurity may be responsible for freshly found toxicity/side effects rather the main API itself.

Keywords: Active Pharmaceutical Ingredients (API); Critical Process Parameters (CPP); Critical Process Variables (CPV); Good Manufacturing Practices (GMP); Micro, Small, Medium Enterprises (M S M E)

Copyright: © 2018 BK Chakravarthy. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.