Documentation is related to the pharmaceuticals how to store documents, their types of storage,method of storage with different software's used in it.

1. Aragade Prity S.
(M. Pharm I semester)
13/12/2014
1
DOCUMENTATION
Prof. Aswar M.K.
(Head of Pharmacology)
SINHGAD INSTITUTE OF PHARMACY, NARHE

2. CONTENT
Introduction
Importance
Preparation
Types
Documentation process
Documentation technique
Applications
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3. INTRODUCTION
A communicable material which contain
systematically written specification, graphical
presentation, description, procedure,
instruction, observations regarding some
attributes of system, such as its parts,
assembly, installation, maintenance and use.
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4. IMPORTACE OF DOCUMENTATION
 Avoids confusion
 Reflects each step
 Review on or focuses on each step
 Proper presentation of data
 Increases convenience to judge performance
 Important in research proposal
 Saves time
 Reference for new comers
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5. PREPARATION OF DOCUMENTATION
Documentation should be
 Simple
 Clear
 Accurate
 Meaningful
 Point wise
 Permanent
 Complete
 Truthful
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6. TYPES OF DOCUMENTATION
Personal document
• Include autobiography, diaries, memories, letters,
observations
• Utilized for research purpose (play major role in research)
Company document
• Require document to operate every process effectively
• Include proposal, contract, report detailed summary,
financial statement
Public document
• Document issued or published for public knowledge.
• Court records, land deeds, and public registers
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7. DOCUMENTATION PROCESS
Good documentation
Right amount of documentation
Document control system
Storage of documentation
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8. Good documentation
 Clear
 Concise
 User friendly
 Nicely written
 Less words
 Point wise
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9. Examples of documents
 Thesis
 Book
 Manuscripts
 Case history
 News paper article
 Bank documents
 Insurance document
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10. Right amount of documentation
 Work instructions written for virtually everything
 Overlap and repetition
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Avoid Creating too Much

11. Or too little
• Lack of work instructions where the process affects
the quality of the product.
• Employees have their own way of performing
processes
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12. Document control system
What
should be
control
Procedures
Attachments
Forms
Work
instructions
Manual
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13. Clarify terminologies
Procedures : Describes the process
Work instruction : Tells how to perform the
process
Attachments : Information attached to the
procedure to help clarify the procedure.
Manuals
Form
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14. Selection of specific system for documentation based on
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Research work
Company size
Computer set-up and availability
Number of different process performed
Rate of change in documentation
Storage of documentation

15. A simple word processing program.
For example, Word.
An existing database program
A packaged document control software.
Document stored in following format
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16.  Simple hardcopy system
 Procedure and work instruction are written on paper
and place near the equipment
 E.g. Standard operating procedure (SOP) of FTIR, SOP
of U V visible spectrophotometer
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17.  Online system
 Procedure and work instruction are written in or
loaded into the system
 Document can printed , having validity for a day they
are printed
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18. Documentation technique
• Note card
• sheet
• chart
Manual
• Software'sElectronic
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19. Tab.1 Note card documentation format
TITLE To study accelerated stability study of paracetamol
PURPOSE To check stability
HYPOTHESIS Sample may be stable
SAMPLE paracetamol
TEST Accelerated stability testing
RESULT Drug is stable
REFERENCES ICH guideline
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Manual documentation

20. Tab.2 Sheet and chart documentation format
TEST DATE
SR.NO SAMPLES OBSERVATIONS MEAN
OBSERVATIONS
A B C
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Title : Accelerated stability study
DRUG AND HPMC
Sr No
40° C & 75% RH 30° C & 65% RH
Days Percentage
Assay %
Days Percentage
Assay %
1 7 51.52 7 55.97
2 14 - 14 -
3 21 242.35 21 51.84
4 28 23.96 28 24.97

22. Electronic documentation
Software's used in documentation
Spreadsheet
Lotus 1-2-3 and MS-DOS spreadsheet
Microsoft Excel
IBM Lotus symphony
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Computer assisted telephone interviewing (CATI)
Computer assisted personal interviewing (CAPI)
Computer assisted web interviewing (CAWI)
Statistical package for the social sciences(SPSS)

24. Spreadsheet
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These are frequently used for financial information
because of their ability to recalculate the entire sheet
automatically after a change to a single cell

25. IBM Lotus symphony
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It is a suite of applications for creating, editing, and sharing
text, spreadsheet, presentations and other documents and
browsing the world wide web.

26. Computer assisted telephone interviewing (CATI)
It allows the interviewers to perform multiple tasks of
interviewing , data entry and simple coding
simultaneously.
The interviewers feed the information directly into
the computer system.
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27. Computer assisted personal interviewing (CAPI)
It is an interview technique similar to CATI except
that the interview takes place in person instead over
the telephone
If no interviewer is present , the term computer
assisted self interviewing (CASI) may used
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28. Computer assisted web interviewing (CAWI)
It is an Internet Data Collection (IDC) method.
The CAWI questionnaires appear onto the browser in
one or more web-pages and respondents can reach in
different way
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29. Statistical package for the social sciences (SPSS)
Commonly used for
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Market research
Survey companies
Health researchers
Government
Educational researcher

30. • Education
Provide a large data bank of information
Aid to time-tabling
• Commerce
Assist the production of text material (known as word
processing) such as reports, letters, circulars etc.
• Banks and Financial Institutions
Cheque handling
Updating of accounts
Applications
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31. • Management
Planning of new enterprises
Finding the best solution from several options
• Industry
In process control
In production control
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32. Key Reference
 Kokare C.R., (2013), Research Methodology, First
Edition, Nirali Prakashan , Pune,14.1-14.8.
 http://www.ismp.org/quarterwatch/pdfs/2013Q1-Kids-
Special.pdf (Accessed:26/10/2014).
 McKenna E., Business Psychology and Organizational
Behavior : A Students Handbook, Third Edition, Vikas
Publishing House, Jangpura,18-21.
 http://www.esds.ac.uk/news/goodPractice.pdf
(Accessed:24/10/2014).
 https://kiedit.ki.se/sites/default/files/h9_handbok_forsk
ningsdokumentation.pdf( Accessed:23/10/2014).
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33.  http://www.unesco.org/education/aladin/paldin/pdf/cour
se02/unit_01.pdf (Accessed:24/10/2014).
 http://www.cdc.gov/healthyyouth/evaluation/pdf/brief1
8.pdf (Accessed:23/10/2014).
 http://ebooks.narotama.ac.id/files/Core%20Concepts%2
0of%20Accounting%20Information%20Systems/CHA
PTER%203%20Documenting%20Accounting%20Infor
mation%20Systems.pdf (Accessed:25/10/2014).
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