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DRUG MASTER FILE (DMF) PowerPoint Presentation

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Description : Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) about the manufacturing, processing, packaging, and storing of one or more human drugs.

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Published on : Oct 28, 2022 | Views : 4095 | Downloads : 1

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DRUG MASTER FILE(DMF)
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Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) about the manufacturing, processing, packaging, and storing of one or more human drugs. It contains factual and complete information on a drug product's chemistry, stability, purity, impurity profile, packaging, and the cGMP status of any human drug product. Drug Master File (DMF)
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Requirements for a DMF Who Must File a DMF? NOBODY There is no legal or regulatory requirement to file a DMF. Information can be in an Application (NDA or ANDA) OR a DMF.
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TYPES OF DRUG MASTER FILES There are five types of DMF's: Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product Type III Packaging Material Type IV Excipient, Colorant, Flavor, Essence Type V FDA Accepted Reference Information
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DMF Process DMF Submissions include drug substance information for the following 5 Modules that are reviewed by the FDA upon receipt of an application: Module 1: Administrative information and prescribing information Module 2: Overviews and summaries of Modules Module 3: Quality (pharmaceutical documentation) Module4:Non-clinicalreports (pharmacology/toxicology) Module 5: Clinical study reports (clinical trials) Drug Master File (DMF)
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DMF Review Process FDA performs a complete review of the referenced technical information in a DMF FDA reviewers may find deficiencies in the information provided in a DMF and a letter describing the deficiencies is sent to the DMF holder. Reviewers may find that the DMF cannot be used to support approval of an ANDA, NDA, or BLA. In these cases, FDA will contact the DMF holder and the agent, if applicable, regarding its concerns. FDA may also visit the manufacturing site to perform the onsite inspection FDA upon completion of through review of DMF, responses and site inspections will only provide necessary approvals of finished formulation application. FDA also performs site inspection generally in 2 years time (or more often sometimes) ( non-compliances could lead to warning letter, import alerts etc) Drug Master File (DMF)
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DMF Changes and Annual Report DMF Holders are required to update the DMF when any changes or amendments are made to the DMF DMF Holders are also required to submit on an annual basis a letter confirming that the filed DMF is current If a company has not submitted an annual report for three years, the agency sends an “Overdue Notification Letters” to DMF holders. Drug Master File (DMF)
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DMF communicates quality, safety and efficacy of the drug that is internationally accepted. Manufacturing facilities with DMF can apply for IND, NDA, ANDA with FDA. DMF plants maintain highest standards of manufacturing practices to ensure quality and Safety of the Drug. It is believed that quality of DMF grade facility product is of highest standard in terms of safety and efficacy. DMFs: What do they bring on table?
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DMF count by countries till June 2020 Sravanti et.al International Journal of Drug Regulatory Affairs. 2021; 9(1): 22-32
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DMF: Critical & Sensitive Aspects to Consider from a pharmacological perspective In support of marketing authorisation application Comparable to global standards Contain information about API, drug products, colorants, flavors etc (whereas EU DMF contains info only about active substance) DMF approved drugs meets the intersection of quality, safety and affordability
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Introducing… API comes from DMF facilities approved by USFDA, EU GMP, WHO GMP certified plants Innovation that brings world class quality drugs at affordable price Supports regulatory requirements of USFDA and proves the quality, safety and efficacy standards
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THANK YOU