July 2019 – ramanmehta

When was the Process Validated? –Unknown Truth in Biopharmaceuticals

By Raman MehtaJuly 26, 2019July 26, 2019

USFDA release the guidance documents on Process Validation titled “Process Validation: General Principles and Practices” in January 2011. However the approach laid down in this document is still being not adopted completely by the industries till date. The concept laid down was to transfer the complete process optimization activities to R & D from manufacturing instead of struggling during the Production phase. This would lead to cost saving and reduces the chances of failure of the product when it has been transferred to the manufacturing phase.

4 Reasons to eliminate the Data Integrity Issues

By Raman MehtaJuly 24, 2019September 14, 2019

Fate of your decision lies in data accuracy. When you take a decision, it may be a good decision or a bad one. However the same is completely dependent on the accuracy of the data being evaluated by you, same applies to the Management Information System also.
The decision of the management may go wrong in case there is inaccurate data and inadequate Management Information System.
These are the two sides of the same coin, however, they are taught to us in different way.

“Smoke” Study of 21st Century in Pharmaceuticals Industry

By Raman MehtaJuly 23, 2019February 11, 2024

Air Flow Pattern or Smoke studies have been one of the interesting areas for the Inspectorates, nowadays. There is very low amount of attentions being paid by the organization when we are designing the smoke pattern protocols and reviewing the videotapes. Sometime situations are there companies do not understand how to review the Air Flow Pattern or Smoke study recordings. This article shall explain everything on the topic and bring the clarity on each segment of Air Flow Pattern. It will make Smoke Study so simple.

Raman Mehta

Raman Mehta is a versatile experienced Bio-pharmaceutical professional with more than 13 year of experience in Sterile and Non-Sterile Formulations. Raman is working in different aspects of Sterile Validations and designing Pharmaceuitcals Quality Systems for the next century. He is a versatile and tech savvy professional who believe the Quality is the foundations of Growing Organizations