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Drug Masters File Drug Master Files. A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential information about a drug. The information contained in the DMF may be used to support an Investigational New Drug Application (IND), a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), another DMF, or an Export Application. DMF's are generally created to allow a party other than the holder of the DMF to reference material without disclosing to that party the contents of the file. An example might be a finished drug manufacturer who wants to reference information about a drug substance from another company which wants to keep their processing information confidential. VCI can write DMF's for you. Validation Master Plan. A Validation Master Plan (VMP) is an integral part of a well organized validation project. It documents the company's approach to complex validation projects. The VMP has a broad scope. It clarifies responsibilities, general objectives, procedures to be followed for validation, and it prioritizes multiple validation tasks. It may reference several protocols and procedures to be written in order to conduct the qualification of several different pieces of equipment and different processes. It may also specify schedules for validation and the allocation of resources needed to perform the validation. Your VMP provides a means of communication to everyone associated with the project. It lets management know how the company’s resources are being allocated and when they will see the results. It tells the validation team what they have to do, when they have to do it, and gives them a means of tracking progress. Other groups can find out what the validation team is doing and what their roles are in support of the validation project. FDA can look at the VMP and realize that the validation project is well thought out and organized; that there is a logical reason for including or excluding every system from the validation project based on a risk analysis. Vic's experience at writing Validation Master Plans can make your project go smoother whether it’s a new, Greenfield plant, expansion of an existing facility, or a rearrangement of operating equipment. |
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