This document discusses documentation practices in the pharmaceutical industry. It emphasizes that quality cannot be ensured without good documentation, which involves systematic interaction between people, events, and documents. Documentation includes procedural documents, instructions, records, and various regulatory requirements. Records provide legally valid evidence and help ensure quality and consistency. The document then discusses specific documentation requirements like master formula records, drug master files, and distribution records. It provides examples of required information and formats for documentation.

1. Dr. Prakash Goudanavar
DEPARTMENT OF PHARMACEUTICS
Sri Adichunchanagiri College of Pharmacy.

2. DOCUMENTS
Quality can not be assured in a
regulated industry without good
documents and good documentation
practices.
A document system is an
interdependent, interrelated set of
documents, each with a defined purpose
and a consistent format.
Documentation is a process that involves
the systematic interaction of people,
events and documents to create the
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3. Documentation for QMS.
 Documents-procedural or instructional
documentation.
 Records-evidence of compliance.
21CFR part 211subpart J
EU GMP Chapter 4.
ICH Q7 section 6.
Drugs and Cosmetics Act schedule M & U.
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4. Documentation for QMS
 Records.
 Data – Documents and Records.
 Batch Manufacturing Record, Analytical
Report, Validation Report etc.
 Invaluable communication tool for Business.
 Provides background history.
 Preserves learning and knowledge.
 Protects intellectual property.
 Provides legally valid evidence.
 Ensures the quality and consistency of
processes/activities/manufacturing.
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5. Documentation and Records.
Documentation System
Quality Policy.
Quality Manual.
Site Master File.
Standard Operating Procedures(SOPs).
Qualification : Protocols and Records.
Validation: Protocols and Records.
Process Development Reports.
Technology Transfer Reports.
Training Records.
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6. Good Documentation Practices.
General Requirements.
• Deliberately amending and destroying GMP records to
hide or falsify data is fraud.
• Do not discard a GMP record just because you might
have made mistake, it is still required for traceability.
• It is not acceptable to discard GMP records for any
reason unless the retention period expiry is reached.
• Loose unofficial papers notes and uncontrolled
documents that can easily be lost or changed without
appropriate approval do not meet GDP requirements.
• Do not use note books/legal pads with easily removed
pages, scrap paper or post-it-notes to record GMP
information.
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7. Master Formula Records
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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8.  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.
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9. The master Formula shall
include
(a) the name of the product together with
product reference code relating to its
specifications;
(b) the patent or proprietary name of the
product along with the generic name,
description of the dosage form, strength,
composition of the product and batch
size;
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10. (c) a statement of the processing
location and the principal equipment to
be used.
(d) name, quantity, and reference
number of all the starting materials to be
used. Mention shall be made of any
substance that may .disappear. in the
courts of processing.
(e) a statement of the expected final
yield with the acceptable limits, and of
relevant intermediate yields, where 10

11. (f) The methods, or reference to the
methods, to be used for preparing the
critical equipment's including cleaning,
assembling, calibrating, sterilizing.
(g) detailed stepwise processing
instructions and the time taken for each
step;
(h) the instructions for in-process control
with their limits;
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12. (i) the requirements for storage conditions
of the products, including the container,
labelling and special storage conditions
where applicable;
(j) any special precautions to be
observed; and
(k) packing details and specimen labels.
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17. DRUG MASTER FILE
 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 human drugs.
 Objective: To support regulatory
requirements and to prove the Quality, Safety
and Efficacy of the medicinal product.
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18. REMEMBER
 There is no legal or regulatory requirement to
file a DMF.
 The information contained in DMF may be used
to support an
- Investigational New Drug Application (IND),
- New Drug Application (NDA),
- Abbreviated New Drug Application (ANDA)
- An Export Application
 DMF is NOT a substitute for IND / NDA /
ANDA or export application. 18

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20. TYPES OF DRUG MASTER FILES
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21. SUBMISSIONS TO DRUG MASTER FILES
 Each DMF submission should contain a
transmittal letter, administrative
information about the submission, and
other specific information.
 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
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22. PROCEDURE FOR ACTIVE
SUBSTANCES
An Active Substance
Manufacturer (ASM)
RESTRICTED PART OF DMF
APPLICANT’S
PART OF DMF
OPEN PART CLOSED PART
Content of Drug Master File
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23. APPLICANT’S PART OF DMF
OPEN PART
( AVAILABLE TO APPLICANT)
Active substance
manufacturer
Supplies information to
the applicant
This information includes:
-outline of the manufacturing method
-impurities originating from the manufacturing
method, isolation procedure and degradation
-information on the toxicity of specific
impurities
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24.  The applicant’s part of a DMF is provided by the
ASM to the applicant directly and becomes part of
the application for marketing authorization.
 The applicant’s part of the DMF is still a
confidential document which cannot be submitted
to third parties without the written agreement of the
ASM.
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25. ASM RESTRICTED PART OF DMF
CLOSED PART
( NOT AVAILABLE TO THE APPLICANT)
IT INCLUDES:
Detailed information about…
• Individual steps of the manufacturing method such
as reaction conditions, temperature, etc.
• Validation and evaluation data for certain critical
steps of the manufacturing method, etc
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26. Distribution of records
 Maintainence of records of finished product
is essential to facilitate complete recall of
batch if necessary.
 Distribution records are written data related
to distribution of drug products from the
manufacturer to the distributors.
 The complete data regarding all batches of
drug products should be maintained.
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27.  Distribution records should contain
Name
Strength of product
Description
Name & address of consignee
Date
Control number of drug product
 Information regarding drug products
should be readily available so that
product recall is efficient.
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28.  An inventory card may be maintained to
find out stock position quickly.
 Distribution register should be
maintained.
 Inventory card format
Inventory card
M/S (Name & address of
company)
Name of product:
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29.  Distribution register format
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Distribution records includes documentation
such as invoices,bills of loading,customer
receipts,internal warehousing storage &
inventory records

30. References:-
 www.fda.gov
 www.fda.gov/cder/guidance/dmf.html
 www.emea.eu.int/htms/vet
 http://www.fda.gov/cder/Offices/ONDQA/prese
ntations/shaw.pdf
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