Drug Master Files: Understanding and Meeting your Regulatory and Processing Responsibilities

Drug Master Files: Understanding and Meeting your Regulatory and Processing Responsibilities

As suppliers and contractors work closely with pharmaceutical or biologic finished product manufacturers for a variety of tasks and processes, it is natural that many misunderstandings could happen between them.

The fundamental reason for which this happens is that the parties fail to come to a properly documented and suitable agreement in which the roles and responsibilities are delineated, and the responsibilities that each has in relation to resolution of disagreement of these issues are clarified. Developing, supporting and updating of confidential technical files (Drug Master files) lie at the core of these arrangements.

Doing these activities right helps the suppliers to protect their confidential product and process information from each and every customer and share it only with the Agency. So, what are the ways by which to do this?

This is the learning a webinar from Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, which is being organized on March 31, will impart. Robert J. Russell, a senior global regulatory and CMC expert, will be the expert at this ninety-minute webinar. Please log on to Compliance4all to register for this valuable learning.

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The core of this session, which combines learning of Quality Agreement and DMF (Drug Master Files), is to discuss the advantages for suppliers and drug product manufacturers developing these arrangements together. This session is aimed at the benefit of those in manufacturing, Regulatory Affairs, project management, global supply chain, Research and Development, Quality Assurance and Quality Control, validation, development and preparation of submission materials, and general management.

Over the course of this session, Bob will cover these areas:

• What are DMFs?
• Types of DMFs (Types II, III, IV and V)
• The rationale and preparation process for DMFs
• Why DMFs are important to you and your company
• How DMFs fit into FDA's regulatory processes for review of drug and biologic applications
• Why, more than ever, you may need DMFs to maintain current supplier agreements as well as to develop new business relationships
• What not to include
• DMF Preparation: What you need and why you need it
• The essential components of all DMFs, including:
• The relationship between DMFs and cGMPs
• Tactics for avoiding the most common DMF-related errors
• Tactics for dealing with unique or novel situations/unfavorable reviews
• FDA Review: How FDA reviews DMFs and why
• What you should expect throughout the DMF preparation and filing process
• How to communicate and work with FDA to ensure success
• Components Associated with a DMF:
• DMF vs. Application
• Acknowledgement Letter
• Letter of Authorization
• Changes to a DMF
• Annual updates
• Obligations of a DMF holder
• Transmissions - transmittal letter
• Deficiency letter
• Auditing Vendor
• Inside tips
• Changes to DMF system in last 10 years
• Binder specifications and cover sample
• Japan DMFs
• European DMFs
• Canadian DMFs
• Change control and maintenance: Why accurately maintaining your DMFs is important
• DMFs as "living" documents. DMF updates and amendments
• Types of DMF-related changes that impact drug/biologic applications: production facilities, composite materials, manufacturing processes
• What you must report and to whom - the importance of establishing communication pathways with regulatory agencies, customers and vendors

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About the expert: Robert J. Russell is President of RJR Consulting, Inc. The company assists the pharmaceutical, medical device and biotech industries in understanding and complying with International Regulations affecting compliance, new product development, manufacturing and quality assurance. RJR has offices in Columbus, OH, Washington DC, and Brussels, Belgium with exclusive affiliates across Asia and Latin America.

Bob has 28 years of past industry experience as a CMC specialist, R&D Director and Global Director of Regulatory Affairs for Merion Merrill Dow pharmaceuticals and Cordis-Dow medical devices. He has a BS/MS degree in Chemistry.

Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations.