it includes details information about specifications, test procedures, protocols , reports and distribution records.

1. Documentation In Pharmaceutical
Industry
Name : Gayatri H. Tiwaskar
M.Pharm 1st year (QA)
Guided by : Mrs. Monali N. Dumore
Dadasaheb Balpande College Of Pharmacy ,
Nagpur.
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2. Index
Introduction
Specification
Test procedures
Protocols and reports
Distribution records
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3. What is Documentation ?
 Document is a written report or record that
provides information
 Documentation is a method of preparing a
written material, which describes the process
in terms of specifications ,instructions etc.
 Document is a piece of written, printed or
electronic matter that provides information or
evidence.
 A Good Documentation is essential part of QA
system .
3

4. Importance of Documentation
 It provides the working details necessary for
manufacturing, packaging, quality control.
 Reduce the risk of mistakes inherent in verbal
communication.
 They help in decreasing the batch to batch
variation so that quality of product is kept with in
the limit of acceptability.
 Documentation and records are essentials for
obtaining ACCREDIATION ,certification of ISO, and
approval by Federal bodies.
4

5. Why Documentation?
There is a saying in the pharmaceutical
industry:
'if it hasn't been documented, then it
hasn't happened!'
“YOUR DOCUMENTATION IS AN
ADVERTISEMENT FOR YOUR WORK .
5

6. Specification
 It is define as a set of parameters expected
to be met by a particular materials, peace of
equipments or any such object.
 Every specification is a company's unique
document and it must have certain common
contents and thereafter each type of
document should have some specific
contents.
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7. In case of pharmaceutical products we need
specifications for
 Active and inactive starting materials
 Primary ,printed and other packaging materials
 Intermediate and bulk products
 Finished pharmaceutical products
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8. A document specification contains several parts:
 a description of the audience(s) for the
document.
 a detailed outline giving the structure and
contents of the document.
 a work plan showing who is responsible for each
part of the document.
 what the deadlines are for completing each
task.
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9. Three purposes for document specifications:
In the workplace, formal document specifications
serve three important functions:
 economy of effort,
 work planning,
 writing organization.
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10. Common Contents
1.Name of the company and its address or location.
2.Title of the document viz. “specification”
3.Date of issue and implementation, effective date,
date of preparation, checking and authorisation,
proposed date of review.
4.Names and signature of persons preparing,
checking, and authorising the specification.
5.Unique identification number
6.Pharmacopoieal or other references
7.Circulation list
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11.  Specific Contents
1. Specification for active and inactive
starting materials.
2. Specification for packaging materials.
3. Specification for intermediate and bulk
products.
4. Specification for finished products.
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12.  Active and inactive starting materials
1.Name of material.
2.Code number references.
3.Pharmacopoial reference to the specific monograph.
4.Qualitative and quantitative requirements,
Physical and chemical characterisation,
microbiological standards and assay etc. Acceptance
limits, covering tests and limits for identity, purity.
5.Name of approved suppliers and original
manufacturer.
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13. 6.Direction for sampling and testing or reference
to the procedures.
7.Storage conditions and safety precautions.
8.The maximum period of storage before re-
examination.
9.Details of or ref. to test method to be used to
assess compliance with the specification.
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14. Packaging material
1.Name of material.
2.Code number reference.
3.Description of nature, dimensions, and materials
of construction of the components with quality
standards, control limits, mould reference,
drawing and details of the test.
4.List of approved supplies/manufacturers.
5.Sampling instructions.
6.storage conditions.
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15. 7.Frequency of re-examination of stored
components.
8.Details of reference to the test methods to be
used to asses compliance with the specification.
9.A file of reference specimens of current printed
packaging materials should be maintained.
 this should include a colour comparison
standard also.
 each specimens in this must be certified by
the QC personnel.
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16. Intermediate and bulk product
The following things should be added to the
common contents.
 It should be available if these are purchased or
dispatched
 or if data obtained from intermediate products
are used in the evaluation of the finished
products.
 These specifications should be similar to starting
material or finished products .
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17. Finished Products
1.Name of the product
2.Code number reference
3.Names of the ingredients
4.The formula or reference to the formula
5.A description of dosage forms and package
details.
6.Direction for sampling and testing or reference
to procedures.
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18. 7.The qualitative and quantitative requirements
with acceptance limits.
8.The storage conditions and precautions, if
applicable.
9.Shelf life.
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19. 19

20. 20

21. 21

22. 22

23. Test Procedures
 Universal tests/Criteria
• New drug
substance
1
• New drug
product
2
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24. New Drug Substance
The following tests and acceptance criteria are
considered generally applicable to new drug
substances.
 Description : a qualitative statement about
the state (e.g. Solid, liquid) and color of the new
drug substance. If any of these characteristics
change during storage ,this change should be
investigated and appropriate action taken.
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25.  Identification : identification testing should
optimally be able to discriminate between
compounds of closely related structure which
are likely to be present.
Identification tests should be specific for the
new drug substance, e.g., infrared
spectroscopy.
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26.  Assay : A specific, stability indicating procedure
should be included to determine the content of new
drug substance. In many cases it is possible to
employ the same procedure (e. g., HPLC) for both
assay of the new drug substance and quantitation
of impurities.
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27.  Impurities : Organic and inorganic impurities
and residual solvents are included in this category.
(Refer to the ICH Guidelines Impurities in new
drug substances and Residual solvents in
pharmaceuticals for detailed information.)
 as per the ICH guideline Q3 A
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28. Classification of impurities
• Organic
• Inorganic
• Residual solvents
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29. Organic impurities
This may arise during the manufacturing process
or during the storage, they may be identified or
unidentified and volatile or non-volatile, it
includes,
starting material
by-product
intermediates
degradation product
ligands, catalyst and reagents
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30. Inorganic impurities
They may arise in manufacturing process,
they may be known and identified. It
includes,
Reagent, ligands and catalyst
Heavy metals
Inorganic solvents
Other materials ( e.g. charcoal )
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31. Residual solvents
This are the organic and inorganic solvents
which is used during the manufacturing, it
may be easily not removed by
manufacturing process.
This are generally of known toxicity.
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32. Limits
 Each identified specified impurity.
 Each identified unspecified impurity at
or above 0.1%.
 Any unspecified impurity, with a limit of
not more than 0.1%.
 Total impurities.
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33. New Drug Product
 Description : A qualitative description of the
dosage form should be provided ( e.g., size,
shape and color).
 Identification
 Assay
 Impurities
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34.  Specific tests/ Criteria
when the tests have an impact on the quality of
drug substance and drug product.
Tests other than this may be needed in
particular situations or as new information
become available.
34

35. Test
1.
Physicochemic-
al properties
pH of aqueous solution, melting point
and refractive index.
2. Particle size For some new drug substance intended
for use in solid or suspension drug
product, particle size have a significant
effect on dissolution rates,
bioavailability, and/ or stability.
3.Polymeric
form
Some new drug substances exist in
different crystalline form which differ in
their physical properties.
4.Water
content
This test is important in cases where the
new drug substance is known to be
hygroscopic or degraded by moisture
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36. Test
5.Inorganic
impurities
Development and based on
knowledge of the manufacturing
process.
6.Microbial
limits
There may be a need to specify the
total count of aerobic
microorganisms.
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37. 37

38. Protocol
 Protocols are written records clearly defining the
objectives and methods that will be used for the
validation programs.
 An important part of the protocol is the
description of the testing method including who
will test the system, how they will test it and
what data is to be collected and reported.
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39.  Computerized system protocols often include
the three distinct stages as described in PMA
reports:
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ).
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40. Installation Qualification
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41. Operational Qualification
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42. Performance Qualification
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43. Protocol Changes
Document requirements specifies that who and
how changes can be done to parameters,
thresholds, and acceptance criteria.
It is not impossible to make changes after or
during testing, but these changes must be
properly implemented and approved to be
validated.
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44. Protocol for Documentations
1.Serial number of the Batch Manufacturing
Record.
2.Name of the product.
3.Reference to Master Formula Record.
4.Batch/Lot number.
5.Batch/Lot size.
6.Date of commencement of manufacture and
date of completion of manufacture.
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45. 7.Date of manufacture and assigned date of
expiry.
8.Date of each step in manufacturing.
9.Names of all ingredients with the grade given
by the quality control department.
10.Quality of all ingredients.
11. Control reference numbers for all ingredients.
12. Time and duration of blending, mixing, etc.
whenever applicable.
13. pH of solution whenever applicable.
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46. 14. Filter integrity testing records.
15. Temperature and humidity records whenever
applicable.
16. Records of plate-counts whenever applicable.
17. Results of pyrogen and/or bacterial endotoxin
& toxicity.
18. Results of weight or volume of drug filled in
containers.
19. Bulk sterility in case of aseptically filled
products.
20. Leak test records.
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47. 21. Inspection records.
22. Sterilization records including autoclave
leakage test records, load details, date, duration,
temperature, pressure, etc.
23. Container washing records.
24. Total number of containers filled.
25.Total numbers of containers rejected at each
stage.
26. Theoretical yield, permissible yield, actual yield
and variation thereof.
27. Clarification for variation in yield beyond
permissible yield.
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48. 28. Reference numbers of relevant analytical
reports.
29. Details of reprocessing, if any.
30. Name of all operators carrying out different
activities.
31.Environmental monitoring records.
32. Specimens of printed packaging materials.
33. Records of destruction of rejected containers
printed packaging and testing.
34. Signature of competent technical staff
responsible for manufacture and testing.
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49. 49

50. Report
Documentation and records used throughout the
manufacturing process, as well as supporting
processes ( e. g. Quality Control or Quality
Assurance)
It includes,
 Batch Record Forms
 Bill of materials ( BOM)
 Specifications
50

51. Policies
Protocols
Standard Operation Procedure (SOPs)
Work Instructions (WIs)
Check lists
Forms/ long sheets
Certificates of Analyses or Certificates of
Compliance
Technical transfer reports
Test Methods
Training Assessments
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52. Records
Worksheet, notebooks and long books
Manufacturing and packaging instructions
Confidentiality agreements
Change control
Quality system related documents
Quality manual
Validation protocols and reports
Deviation reports
Audit plans
Electronic and hard-copy Quality records
52

53. Test material related documents including
product specification, test material receipt and
reports.
Personal related documents including training
records.
Facility related documents including floor plans,
environmental specifications.
Deviation forms including unplanned deviations
and system failure investigation.
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54. Distribution Records
It contain name and strength of the product and
description of the dosage form, name and address
of the consignee, date quantity shipped, and lot or
control number of the drug product.
Distribution records include a wide range of
documentation such as invoices, bill of lading
customer receipts, and internal warehouse
storage and inventory records.
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55. The information required need not be on every
document.
Also customer codes and product codes may be
used as alternates to customers name and
addresses and product names.
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
necessary.
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56. Document Required
 SOP on distribution of finished
products for sale or sample.
 Records of distribution.
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59. Thank You !
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