Bio Pharma Briefings

In any pharmaceutical industry, DMS (Document Management system) is the backbone of the whole system.  During the regulatory inspection first thing comes in scrutiny of inspectors is DMS. Starting from the Company policies to recording system of formats is well arranged in Pyramid manner.  Want to know about the Pyramid of Document management system?  Understand the Pyramid of Document Management System (DMS)   But.... How to maintain the Pyramid of DMS? This is the most important thing to know... In parallel to the Document system management, one very wonderful system is also evolved. This system is known as QMS(Quality Management system) . The main role of QMS is to protect DMS. Nexus of DMS and QMS With writing of documents to run the manufacturing process to analyze the drug to sell the drug in market and finally to consume the medicine, In these whole cycle human is involved.  Where human interventions are there, chances of making errors are always there. In addition to that to c

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

As a Biopharma professional understanding of any process of drug manufacturing is very important. furthermore, important is to Product quality and Patient safety. With aim of to provide consistent quality of drug, any industry run their business. "Product Quality" is top tagline but how we can achieve it? Product quality can achieve by designing the quality. What?  Yes First step is QbD(Quality by Design). What is QbD? QbD is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management.(ICH Q8 R2). Let's Understand the definition: First of all Firm should have pre-defined objective means what type of product quality is required. The second thing we should have understanding of Product and Process. The third thing we should have a sound scientific rationale.   Once we have above mentioned three things, then we can do the quality risk manag

  In Today's world Pharmaceuticals are considered as most reputed and highly regulated industries in worldwide. Of course Why not? When any matters comes directly to the safety of patient health, this will be very critical. To control and regulate the culture of safe medicine to the patient, government has prepared the regulatory body. The regulatory body ensure the compliance in various aspect of drug starting from drug development to marketing of drug. Main duty of Regulatory Body/Agency : Issue the guidelines to regulate Drug development process, Licensing, Registration, Manufacturing, Marketing and Labelling.     List of important regulatory body of various countries with web links are provided in below table.  Sr. No. Country Name of Regulatory body/Agency Direct Website link 1 India Central Drug Standard Control Organization (CDSCO) https://cdsco.gov.in/opencms/opencms/en/H