Clarifying the misconceptions about DMFs and Quality Agreements

[Adam Fleming]

A Drug Master File (DMF) is a file that lists the materials and processes that have gone into a drug. This submission is made by manufacturers of drugs to the FDA, and has to contain everything that goes into the drug, and has to include not only the materials and the processes; but also confidential information pertaining to the facilities in which the drugs are manufactured. All the inputs that have gone into not just the manufacturing, but also the packaging and storing of all human drugs made by the manufacturer, have to be entered in the DMF.

The FDA’s line of thinking is that all this information has to be provided to it so that it will help the manufacturer protect any confidential or proprietary information relating to its manufacturing process by keeping them with the FDA.

The FDA has issued a number of guidances to the industry about the way in which these submissions have to be made in both paper and electronic format. It has detailed information about how each of these is to be made. This format is set to change, because from May 18, 2018; only DMF submissions made in electronic format under the FDA’s Electronic Common Technical Document (eCTD) will be accepted, and the FDA will reject any DMF submissions made in paper format from that date onwards.

The Quality Agreement

A Quality Agreement (QA) is an important document that goes some way in ensuring the quality of drugs and preventing their contamination and counterfeiting. It is an agreement made between the manufacturers of API or intermediate manufacturers and their suppliers to ensure that the responsibilities for assuring the safe supply of materials are safe to be accepted for pharmaceutical use.

A Quality Agreement stipulates and clearly defines the responsibilities of both the manufacturer and the supplier, and states their respective obligations towards ensuring the quality and safe supply of the API or intermediate user. The Quality Agreement is a major component of the API or intermediate user’s supplier qualification program.

While this is a laudable intention, it has a side effect: Misunderstanding between manufacturers of pharmaceutical or biologic finished products on the one side, and supplier and contractors, on the other, because the FDA states that all the proprietary information is to be stored with it only.

This has given way to considerable confusion and misconception about the nature of the DMF submission and the way in which the Quality Agreement has to be drafted. Yet, it is important to clear the misconceptions and misunderstandings at an earlier stage of the agreement, because proper understanding of the requirements and responsibilities alone can ensure the proper quality of the final product.

The aim of a webinar that is being organized by Compliance4All, a leading provider of professional trainings for the areas of regulatory compliance, is to clear the many misunderstandings between the supplier and the manufacturer.

The speaker at this webinar is Robert J. Russell, who is President of RJR Consulting, Inc., which is engaged in assisting the pharmaceutical, medical device and biotech industries in understanding and complying with International Regulations affecting compliance, new product development, manufacturing and Quality Assurance. To have misconceptions in the various areas of DMF and QA clarified, please register for this webinar by visiting Regulatory and Processing Responsibilities

This training will combine Quality Agreement and DMF, and is meant for suppliers and drug product manufacturers developing these arrangements together. Robert will discuss the advantages of this system.

He will offer understanding into the nature of the misunderstanding that has arisen over the years. The main reason for this is the lack of a thoroughly drafted agreement that delineates roles and responsibilities. The speaker will explain how this can be corrected by clearly stating the means for resolution of issues.  

This will be the agenda of this webinar:

o  What are DMFs?

o  The rationale and preparation process for DMFs

o  DMF Preparation: What you need and why you need it

o  FDA Review: How FDA reviews DMFs and why

o  Components Associated with a DMF

o  Japan DMFs

o  European DMFs

o  Canadian DMFs

o  Change control and maintenance: Why accurately maintaining your DMFs is important