Bio Pharma Briefings

Year 2020 was the most challenging and lesson taking year for the whole world. Corona virus pandemic has changed the way of life by one or another way.   The situation is like "Run the show anyhow."  Currently, it is big challenge for industry to serve for the society with affordable and quality medicines.  Even regulators are concerned with the standard of the medicines produced and supplied across globe during this pandemic as currently it is not possible for conduct onsite inspection for international travel restriction. Hence  regulators have directed the inspection on remote mode. This remote mode inspection is know as "Desktop Audit" or "Desktop Inspection." When regulatory bodies do the inspection remotely to the pharma firms, it is very important to win the trust factor of the inspectors. Remote mode of inspection is new concept for the industry and it is very interesting. Before starting the journey, let's understand the Definition of Desktop ...

In all Pharmaceuticals and B iopharmaceuticals industries, documents play an important role.  A very practical saying says that, "IF IT IS NOT DOCUMENTED, IT WAS NOT DONE" But, how documents come into existence and what is flow of documents in the industry. The hierarchy of documentation makes a lot of sense and it is interesting. Level of Documentation system One must understand that, Any organization or industry starts with the some motive and vision/objective. This one line note which is known as "Visionary Note" or "Objective line" .   This one-line message is very directive as it provides the general idea to the people of the foundation.     "Visionary Note" is owned by the Founder or the chairperson of the Organization. Based on the Visionary Note, Board of Members writes the "Policy" . What is Policy? A policy is a deliberate system of principles to guide decisions and achieve rational outcomes. It is also known as "Concept...