Documentation In Pharmaceutical Industry(Master Formula Record,DMF,Distribution Record)

1. DEPARTMENTOFPHARMACEUTICS
TOPIC: DOCUMENTATION IN PHARMACEUTICAL
INDUSTRY(MASTER FORMULA
RECORD,DMF,DISTRIBUTION RECORD)
PRESENTED BY: RUSHIKESH SHINDE
(M.Pharm,First Year)
GUIDED BY: DR.NALANDA BORKAR MADAM
(Head Of Department Of Pharmaceutics)
Survey No. 50,Marunje,Near Rajiv Gandhi,
IT Park, Hinjawadi,Pune,Maharashtra,411028
ALARD COLLEGE OF PHARMACY
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2. Master Formula Record
DMF
Distribution Record
Subtopics:
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3. MASTER FORMULA RECORD
Definition:
A document or set of documents specifying the
starting materials with their quantities and the
packaging materials, together with a description of
the procedures and precautions required to produce
a specified quantity of a finished product as well as
the processing instructions, including the in-
process controls.
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4. MASTER FORMULA RECORD
Master Formula Record (MFR) is a master document
for any pharmaceutical product.
MFR contains all information about the
manufacturing process for the product.
MFR is prepared by the research and development team of
the company.
MFR is used as reference standard for preparing batch
manufacturing record (BMR) by manufacturing units.
MFR is also called Master Manufacturing Record,
Master Production Record 4

5. There shall be Master Formula records
relating to all manufacturing procedures for
each product and batch size to be
manufactured. These shall be prepared and
endorsed by the competent technical staff i.e.
head of production and quality control.
MFR plays an important in consistency for each batch
manufacturing
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6.  MFR should contain
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 Product Details :
 Name, logo and address of the manufacturing
company.
 Dosage form name.
 Brand name.
 Generic name.
 Product code
 Label claim of all ingredients
 Product description
 Batch size
 Pack size and packing style

7.  Shelf life
 Storage conditions
 MFR number and date
 Supersede MFR number and date
 Effective batch number
 Authorization by the production and quality
assurance head
 Flow Chart: Steps of the manufacturing
process to be monitored. Flowchart of the
material movement from dispensing to the final
product to stores.
 Equipment: Create a list of all required
equipment and machines required in the
manufacturing process with their capacity. 7

8.  Special instructions: Write down the
precautions special instructions to follow
during
product manufacturing and packing and these
should also be added in the batch
manufacturing formula.
 Calculations: Include the
calculation steps of all active
materials to get the 100% of the
active material. The calculation
shall be done using water or
LOD to get 100% potency.
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9.  Manufacturing Process: Write all steps in
all stages of the manufacturing process. All
process steps like shifting, milling, lubricating,
granulation, compression and coating should
be written in detail including the process time
and yield.
• It also include atmospheric conditions as
temperature, humidity, and storage conditions
for every step.
 Packing Process: List of all packing
materials with their quantity is written. Line
clearance, reconciliation of printed and
unprinted packing materials should be included
in details.
 Yield: Include the theoretical, actual yield
and acceptance limit of the batch.
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11. Contents
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Introduction
Types of DMF
Submission of DMF – 1.Transmittal letter
2.Administrative Information
Authorization to refer DMF
Holder Obligation
Closure of DMF file
DMF(DRUG MASTER FILE)

12.  Introduction
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 A Drug Master File (DMF) is a submission to the Food and Drug
Administration (FDA) that may be used to provide confidential detailed
information about facilities, processes, or articles used in the manufacturing,
processing, packaging, and storing of one or more humandrugs.
 The submission of a DMF is not required by law or FDA regulation and a
DMF is submitted solely at the discretion of the holder (a person who owns a
DMF).
 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, an
Export Application, or amendments and supplements to any ofthese.
 But a DMF is NOT a substitute for an IND, NDA,ANDA, or Export
Application.

13.  Drug Master Files are provided for in 21 CFR 314.420.
 This guideline is intended to provide DMF holders with procedures
acceptable to the agency for preparing and submitting a DMF.
 The guideline discusses types of DMF's, the information needed in
each type, the format of submissions to a DMF, the administrative
procedures governing review of DMF's, and the obligations of the
DMF holder.
 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.
 When an applicant references its own material, the applicantshould
reference the information contained in its own IND, NDA, or
ANDA directly rather than establishing a newDMF. 13

14.  Types of Drug master file
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TYPES ESSENTIAL CONTENTS
I Manufacturing site, facilities,
operating procedure and personnel
II Drug substance & intermediate, material
used and drug product
III Packaging material
IV Excipient , flavor , essence,
colorant, & material used in
preparation
V FDA accepted reference information

15. Submissions Of Drug Master Files
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 Each DMF submission should contain a transmittal letter, administrative
information about the submission, and the specific information to be included
in the DMF as described in thissection.
 The DMF must be in the English language. Whenever a submission contains
information in another language, an accurate certified English translation must
also be included.
 Each page of each copy of the DMF should be dated and consecutively
numbered.
 An updated table of contents should be included with each
submission.

16.  Transmittal Letters
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 Identification of submission: Original, the type of DMF as classified in
Section III,
 its subject.
 Identification of the applications, if known, that the DMF is intended to
support, including the name and address of each sponsor, applicant, or holder,
and all relevant document numbers.
 Signature of the holder or the authorized representative.
 Typewritten name and title of the signer.
 Administrative Information
a. Names and addresses of the following:
1) DMF holder.
2) Corporate headquarters.
3) Manufacturing/processing facility.
4) Contact for FDAcorrespondence.
5) Agent(s), if any.
b. The specific responsibilities of each person listed in any of the categories.
c. Statement of commitment-A signed statement by the holder certifying that
the DMF is currentand that the DMF holder will comply with the statements
made in it.

17. Authorization ToReferA Drug
Master File
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 Letter of Authorization to FDA
 Before FDA can review DMF information in support of an
application, the DMF holder must submit in duplicate to the
DMF a letter of authorization permitting FDA to refer the DMF.
 If the holder cross refers its own DMF, the holder should supply
in a letter of authorization the information designated by items
3, 5, 6, 7, and 8 of this section. The holder does not need to
send a transmittal letter with its letter ofauthorization.

18.  The letter of authorization should include the following:
 The date.
 Name of DMF holder.
 DMF number.
 Name ofpersons authorized to incorporate information in the
DMF by reference.
 Specific products covered by the DMF.
 Submission dates
 Section numbers and/or page numbers to be referenced.
 Statement of commitment that the DMF is current and thatthe
DMF holder will comply with the statements made init.
 Signature of authorizing official.
 Typed name and title of official authorizing reference to theDMF.
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19.  Holder Oligation
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 The reference should include the date, volume, section, and/or
page number affected.
 Any change or condition including a change in
authorization related to specific customers should
be submitted in duplicate and adequately cross
referenced to previous submission

20. Closure OfADrug MasterFile
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• A holder who wishes to close a DMF should submit a
request to the Drug Master File Staff stating the reason for
theclosure.
• The request should include a statement that the holder's
obligations.
• 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 theDMF.

21. Distribution Procedures-
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Distribution Record

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26.  Distribution records shall contain the name and strength of
the product and description of the dosage form, name and
address of the consignee, date and quality shipped, and lot or
control number of the drug product. For compressed medical
gas products, distribution records are not required to contain
lot or control numbers.
 The primary purpose is to ensure that adequate data are
available to access trade customers should a recall be
initiated. The recording of lot number to each order will
certainly accomplish this purpose.
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27.  The recordings of dates on which a specific lot of product
commenced and ceased distribution may be used. All
customers receiving the product between these dates could
then be contacted.
 Obviously on the first and last days of distribution, some of
the customers may have received product from the end of
previous lot or the beginning of the next lot.
 This overlap should in no way adversely impact on the
effectiveness of a recall.
 Whatever system is used, it must accommodate the
reintroduction of returned goods into the distribution chain.
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28.  Distribution records include a wide range of documentation
such as invoices, bills of lading, customers’ receipts, internal
warehouse storage and inventory records.
 The information required need not be on every document.
Also customer codes and product codes may be used as
alternates to customer names and address and product
names.
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29.  References
I. Generic Drug Product Development, Solid Oral Dosage forms, Leon Shargel
and IsaderKaufer,Marcel Dekker series, Vol.1432.Assesed Date:23rd Feb,2021
II. The Pharmaceutical Regulatory Process, Second Edition Edited by Ira R. Berry
and Robert P.Martin, Drugs and the Pharmaceutical Sciences,Vol.185, Informa
Health care Publishers.Assesed Date:24th Feb,2021
III. Guidebook for drug regulatory submissions / Sandy Weinberg. By John Wiley
& Sons.Inc. Vol.1432.Assesed Date:23rd Feb,2021
IV. FDA regulatory affairs: a guide for prescription drugs, medical devices, and
biologics/edited By Douglas J. Pisano, David Mantus. Publishers.Assesed
Date:24th Feb,2021
V. https://www.slideshare.net/Documentation In Pharmaceutical Industry.Assesed
Date:24th Feb,2021
VI. www.fda.gov/Documentation.Assesed Date:24th Feb,2021.
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