drug master file and distribution record of drug in pharmaceutical industry and its types

1. DMF AND DISTRIBUTION
RECORD
Prepared by
Mr. Shubham Kailas Shete
(F Y M.Pharm Pharmaceutic’s)
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2. DMF-DRUG MASTER FILE
 A drug master file is a submission to the FDA that
may be used to provide confidential detailed
information about facilities , processes or articles
used in the mfg, processing, packaging and storing
of one or more human drugs.
 The DMF contains complete info on a drug
products chemistry, mfg, stability, purity, impurity
profile, packaging and the cGMP status of any
human drug.
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3. WHO MUST FILE A DMF ?
 There is a no legal or regulatory requirements to file
a DMF.
 The information contained in DMF may be used to
support an IND/NDA/ANDA, another DMF, an
export application.
 Always Remember that DMF is NOT a substitute
for IND /NDA/ANDA or export application.
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4. TYPES OF DMF
 There are five types of DMF as :
 Type I : Plant information
 Type II: Drug substance, drug product,
intermediates and material used in their mfg.
 Type III: Packaging
 Type IV : Excipients
 Type V: Other information which is generally
not covered by Type I to IV DMF.
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5. TYPE I : PLANT INFORMATION
This type of DMF includes
 Mfg plant
 Equipment capabilities
 Operational layout
 Actual plant address
 A map showing its location
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6. TYPE II
It includes :
 1. Drug substance intermediates , drug substance and
material used in their preparation.
2. Finished drug product : mfg procedures and controls for
finished dosage form.
General points included in type II DMF as
 Mfg section
 Quality control- Raw material
-Packaging material
- Intermediates
-In process Q.C
-Finished Drug Substances
 Validations
 Stability data 6

7. TYPE III: PACKAGING MATERIAL
It includes:
 Packaging material intended for which use.
 Its components and compositions.
 Names of suppliers.
 Toxicological data on these materials .
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8. TYPE IV: EXCIPIENTS
 CMC (Chemistry ,mfg, &controls) requirements for
a novel excipients should be submitted same as
Type II DMF.
 It includes Excipients such as colorants, flavors,
essence etc. or ,materials used in their preparations
.
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9. TYPE V: OTHER INFO.
 Other information which is generally not covered by
Type I to IV DMF .
 Such as miscellaneous information .
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10. DISTRIBUTION RECORD
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11. DISTRIBUTION RECORD
 Distribution record shall contain the name and
strength of the product and description of the
dosage form, name and lot or control number of the
drug product.
 For compressed medical gas product, distribution
records are not required to contain lot or control
numbers.
 The primary purpose of this section is to ensure
that adequate data are available to access trade
customers should be initiated.
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12. DISTRIBUTION RECORD
 Customer codes and product codes may be used
as alternates to customer names and addresses
and product name.
 Records for distribution shall be maintained in a
manner such that finished batch of a drug can be
traced to the retain level to facilitate prompt and
complete recall of the batch, if and when necessory.
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13. DISTRIBUTION RECORD
Distribution Record Should contain:
 Name of the product
 Strength of the product
 Name and address of consignee
 Date and quantity shipped
 Control number of drug product
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14. REFRENCES
 Sidney H.Willing, “Good Manufacturing Practices
for Pharmaceuticals” Marcel Dekker, Page No 132.
 https://www.slideshare.net.dmf 22/8/2019
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15. THANK
YOU
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