dmf and orange book

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DRUG MASTER FILE & ORANGE BOOK:

DRUG MASTER FILE & ORANGE BOOK KULDEEP KINJA M Pharm (Pharmacology) Second Year Dept. of Pharmacology NIMS Institute of Pharmacy 1

Drug Master File (DMF): :

Drug Master File (DMF): DMF submission to FDA used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. Contains information used to support an Investigational New Drug Application (IND), a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), another DMF, an Export Application, or amendments and supplements to any of these . What is DMF??? Dept. of Pharmacology NIMS Institute of Pharmacy 2

Slide 3:

21 CFR 314.420 guides DMF holders with procedures acceptable to the agency for preparing and submitting a DMF. Guideline discusses Types of DMF's, Information needed in each type, Format of submissions to a DMF, Administrative procedures governing review of DMF's, Obligations of the DMF holder. How to Prepare?? Dept. of Pharmacology NIMS Institute of Pharmacy 3

Slide 4:

DMF's are 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. When an applicant refers its own material, the applicant should refers the information contained in its own IND, NDA, or ANDA directly rather than establishing a new DMF. Use?? Dept. of Pharmacology NIMS Institute of Pharmacy 4

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Type I Manufacturing Site, Facilities, Operating Procedures, & 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, or Material Used in Their Preparation Type V FDA Accepted Reference Information Types of DMF-5 types Dept. of Pharmacology NIMS Institute of Pharmacy 5

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Transmittal letter- Original Submissions, Amendments Administrative information about the submission Original Submissions a. Names and addresses of : DMF holder, Corporate headquarters, Manufacturing/processing facility, Contact for FDA correspondence, Agent(s), if any. b. Specific responsibilities of each person listed in categories in Section c. Statement of commitment: A signed statement by the holder certifying that DMF is current and that DMF holder will comply with the statements made in it. Amendments Specific information as per DMF type. Submissions of DMF-Each should contain Dept. of Pharmacology NIMS Institute of Pharmacy 6

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TYPE I: This DMF should describe manufacturing site, equipment capabilities, operational layout. A diagram of major production & processing areas, major equipments in terms of capabilities, application, and location. Specific Information as per DMF type Dept. of Pharmacology NIMS Institute of Pharmacy 7

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TYPE II : This DMF should describe Drug Substance, Drug Substance Intermediate or Drug Product Material Used in Preparation All significant steps in the manufacturing and controls of the drug intermediate or substance. Should be limited to a single drug intermediate, drug substance, drug product, or type of material used in their preparation. For Drug Product : Manufacturing procedures and controls for finished dosage forms should ordinarily be submitted in an IND, NDA, ANDA, or Export Application . Specific Information as per DMF type Dept. of Pharmacology NIMS Institute of Pharmacy 8

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TYPE III: This DMF should describe Description-Each packaging material Suitability-Protection, Safety, compatibility, Performance Quality control documents Stability studies Data supporting the acceptability of the packaging material for its intended use should also be submitted. Toxicological data on materials or cross reference to another document. Specific Information as per DMF type Dept. of Pharmacology NIMS Institute of Pharmacy 9

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TYPE IV : Used by excipient manufacturers to submit confidential formulation, safety and manufacturing information about the excipient needed by the agency in reviewing a new drug application (NDA) for a drug product containing that excipient. Only referenced by FDA as part of a specific NDA review and are not authorized or approved by FDA. Specific Information as per DMF type Dept. of Pharmacology NIMS Institute of Pharmacy 10

Slide 11:

Type IV: Users of the excipient are required to submit a DMF reference letter from the excipient manufacturer to the FDA as part of their NDA DMF should contain: Each additive added Identified and characterized Method of manufacture & release Testing methods & specifications. Toxicological data on these materials or cross reference to another document. Specific Information as per DMF type Dept. of Pharmacology NIMS Institute of Pharmacy 11

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TYPE V : FDA discourages the use of Type V DMF's for Miscellaneous information, Duplicate information, or Information that should be included in one of the other types of DMF's. Dept. of Pharmacology NIMS Institute of Pharmacy 12

A DMF IS NEVER APPROVED OR DISAPPROVED: :

A DMF IS NEVER APPROVED OR DISAPPROVED : The agency will review information in a DMF only when IND sponsor, An applicant for an NDA, ANDA, or Export Application, or Another DMF holder incorporates material in the DMF by reference. As noted, the incorporation by reference must be accompanied by a copy of the DMF holder's letter of authorization Dept. of Pharmacology NIMS Institute of Pharmacy 13

A DMF IS NEVER APPROVED OR DISAPPROVED: :

A DMF IS NEVER APPROVED OR DISAPPROVED : If FDA reviewers find deficiencies in the information provided in a DMF a letter describing the deficiencies is sent to the DMF holder. At the same time, FDA will notify the person who relies on the information in the deficient DMF that additional information is needed in the supporting DMF. Dept. of Pharmacology NIMS Institute of Pharmacy 14

CLOSURE OF A DRUG MASTER FILE::

CLOSURE OF A DRUG MASTER FILE: A holder who wishes to close a DMF should submit a request to the Drug Master File Staff stating the reason for the closure. The Agency may close a DMF that does not contain an annual update of persons authorized to incorporate information in the DMF by reference and a list of changes made since the previous annual report. The holder will be notified of FDA's intent to close the DMF. Dept. of Pharmacology NIMS Institute of Pharmacy 15

ORANGE BOOK:-:

ORANGE BOOK:- Dept. of Pharmacology NIMS Institute of Pharmacy 16 The publication, Approved Drug Products with Therapeutic Equivalence Evaluations (the List, commonly known as the Orange Book ) It identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under section 505 of the Federal Food, Drug, and Cosmetic Act (the Act). Drugs on the market approved only on the basis of safety (covered by the on going Drug Efficacy Study Implementation [DESI] review

Inclusion Criterion::

Inclusion Criterion: Dept. of Pharmacology NIMS Institute of Pharmacy 17 The main criterion for the inclusion of any product is that the product is the subject of an application with an effective approval that has not been withdrawn for safety or efficacy reasons. Inclusion of products on the List is independent of any current regulatory action through administrative or judicial means against a drug product. In addition, the List contains therapeutic equivalence evaluations for approved multi source prescription drug products .

The List is composed of four parts: :

The List is composed of four parts: Dept. of Pharmacology NIMS Institute of Pharmacy 18 Approved prescription drug products with therapeutic equivalence evaluations Approved over-the-counter (OTC) drug products for those drugs that may not be marketed without NDAs or ANDAs because they are not covered under existing OTC monographs; Drug products with approval under Section 505 of the Act administered by the Centre for Biologics Evaluation and Research ; and Cumulative list of approved products that have never been marketed, are for exportation, are for military use, have been discontinued from marketing, or have had their approvals withdrawn for other than safety or efficacy reasons subsequent to being discontinued from marketing

General Policies and Legal Status: :

General Policies and Legal Status: Dept. of Pharmacology NIMS Institute of Pharmacy 19 The List contains public information and advice. It does not mandate the drug products which may be purchased, prescribed, dispensed, or substituted for one another, nor does it, conversely, mandate the products that should be avoided.

Therapeutic Equivalence Evaluations Codes: :

Therapeutic Equivalence Evaluations Codes: Dept. of Pharmacology NIMS Institute of Pharmacy 20 The coding system for therapeutic equivalence evaluations is constructed to allow users to determine quickly whether the Agency has evaluated a particular approved product as therapeutically equivalent to other pharmaceutically equivalent products (first letter) and to provide additional information on the basis of FDA's evaluations (second letter).

Therapeutic Equivalence Evaluations Codes: :

Therapeutic Equivalence Evaluations Codes: Dept. of Pharmacology NIMS Institute of Pharmacy 21 The two basic categories into which multisource drugs have been placed are indicated by the first letter as follows: A. Drug products that FDA considers to be therapeutically equivalent to other pharmaceutically equivalent products, i.e., drug products for which: 1) there are no known or suspected bioequivalence problems. These are designated AA, AN, AO, AP, or AT, depending on the dosage form; or 2) actual or potential bioequivalence problems have been resolved with adequate in vivo and/or in vitro evidence supporting bioequivalence. These are designated AB.

Therapeutic Equivalence Evaluations Codes: :

Therapeutic Equivalence Evaluations Codes: Dept. of Pharmacology NIMS Institute of Pharmacy 22 B . Drug products that FDA at this time, considers not to be therapeutically equivalent to other pharmaceutically equivalent products, i.e., drug products for which actual or potential bioequivalence problems have not been resolved by adequate evidence of bioequivalence. Often the problem is with specific dosage forms rather than with the active ingredients. These are designated BC, BD, BE, BN, BP, BR, BS, BT, BX, or B*.

The Orange Book:

The Orange Book Dept. of Pharmacology NIMS Institute of Pharmacy 23 TESEC : Trusted Computer System Evaluation Criteria Uses: Evaluation classes and online structure Identifies functional and assurance criteria Both embedded in prose descriptions of named classes Does not match with current requirements engineering methodologies: Example: Life cycle models

Orange book notations::

Orange book notations: Dept. of Pharmacology NIMS Institute of Pharmacy 24 Reference monitor : an abstract machine that mediates all access control decisions Reference validation mechanism (RVM ): an implementation of a reference monitor Security kernal: software+ hardware that implements a reference monitor Trusted Computing Base (TCB): all protection mechanisms that enforce security policy Target of Evaluation (ToE): the subject of evaluation (system or product)

TSEC Evaluation Process::

TSEC Evaluation Process: Dept. of Pharmacology NIMS Institute of Pharmacy 25 Design analysis : Rigorous analysis of system design based on documentation Completeness and correctness criteria Evaluators produce an initial product assessment report (IPAR) Test analysis: Test coverage assessment Executing vender supplied tests Evaluators produce an final product assessment report (FAR) Final review : Results of each of these phases presented to the technical review board (TRB) Review IPAR and FAR and award a rating

Criticisms of orange book criteria::

Criticisms of orange book criteria: Dept. of Pharmacology NIMS Institute of Pharmacy 26 Mixes various levels of abstraction in a single document Does not address integrity of data Combines functionality and assurance in a single linear rating scale

Reference::

Reference: http://www.fda.gov/cder.htm http://apps.who.int/prequal/info_applicants/Guidelines/APIMF_Guide.pdf http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/DrugMasterFilesDMFs/default.htm http://www.ipecamericas.org/public/faqs.html Dept. of Pharmacology NIMS Institute of Pharmacy 27