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1.0
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PURPOSE
To Lay down procedure for practicing Good
Documentation Practices in the company.
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2.0
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SCOPE
This SOP is applicable to
all departments.
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3.0
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RESPONSIBILITY
Operating Staff
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4.0
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ACCOUNTABILITY
All Department Head
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5.0
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PROCEDURE
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5.1
5.2
5.2.1
5.2.2
5.2.3
5.3
5.3.1
5.3.2
5.3.3
5.3.4
5.3.5
5.3.6
5.3.7
5.4
5.4.1
5.4.2
5.4.3
5.4.4
5.4.5
5.4.6
5.4.7
5.4.8
5.4.9
5.4.10
5.4.11
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The
Master copies of all the documents viz. SOPs, Specifications & STPs, BPRs
etc shall be controlled by the Quality Assurance department.
Design and Preparation
of Documents:
The basic format (i.e.
layout) of each document shall be kept intact, which shall be taken from the
original annexure from the respective SOP. Each document shall be assigned a
format number as per respective SOP.
The document shall be
prepared in lucid and easy to understand language, wherever the photocopy of
the original document is used, it shall be ensured that the photocopy is
clear and the text is readable.
Each photocopy shall bear
a ‘controlled copy’ stamp. Only controlled copy of any document shall be used
for recording.
Recording and Review of
documents:
Blue
ball pen must be used by production and green pen used by QA persons when recording
documents.
The
Master copies of all the documents viz. SOPs, Specifications & STPs, BPRs,
validation protocol, MFR etc shall be Signed by the only blue pen.
Information
recorded should be legible i.e. easy to read.
Date
should be recorded in the dot form of Day.Month.Year i.e. 01.04.2012.
Information
should be recorded on the applicable forms of documents /records /
logbooks, immediately after actions are completed. Entries of signatures or initials and
dates must be
made at the same time.
Data
shall be recorded first hand, directly into the respective document i.e. data
shall be recorded concurrent to the activity performed. Postdated or
backdated documentation shall be strictly not allowed. No data shall be
written on scrap paper, rough paper or personal notebooks.
No space or column shall
remain empty in the document. Wherever no recording is required, N/A
(not applicable) shall be
mentioned on the respective column.
Correction of wrong
entries
If a wrong entry of a data
or observation in a document is made, it shall be corrected as follows:
The incorrect data shall
be crossed by a single line so that the original entry / remark or sentence
is legible.
The correct entry / remark
or sentence shall be written just adjacent to original entry.
In no way, the data shall
be changed by overwriting or by any other means.
The person making the
corrections shall then sign with current date.
The person making re-entry
(correct entry) shall ensure the consequences in any (or all) cross
–referenced document and subsequently take necessary action.
If any error is noticed
after elapse of time of the recording the data, this should be brought to the
notice of functional authority
Scrap paper should not be used for
the recording data and original
information always be entered directly
the applicable document.
Any
document must never be post dated or back dated.
Corrective fluid (White
ink) or erasable pens and gel pen should not be used to correct the original information.
No corrections shall be allowed in already approved BMR/BPR/Formats/SOPs or
validation protocols.
If corrections are
required, this shall be done through change control procedure approved by
Quality Assurance for changes in BMR/BPR/SOPs /Formats and
Validation/Qualification protocols. Consequently, no adhoc or temporary
changes are allowed.
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6.0
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REFERENCES
NIL
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7.0
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ANNEXURES
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Annexure No.
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Title of Annexure
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Format No.
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NIL
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8.0
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ABBREVIATIONS
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Abbreviations
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Full Forms
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SOP
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Standard Operating
Procedure
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QA
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Quality Assurance
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9.0
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DISTRIBUTION
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Master Copy
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Head Quality Assurance
Department
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Controlled office Copy No. 1
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Head Quality Assurance Deptt.
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Controlled office Copy No. 2
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Head Quality Control Deptt.
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Controlled office Copy No. 3
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Head Production (Tablet) Deptt.
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Controlled office Copy No. 4
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Head Production (Liquid)
Deptt
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Controlled office Copy No. 5
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Head Production (External)
Deptt
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Controlled office Copy No. 6
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Head Production (Soap)
Deptt
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Controlled office Copy No. 7
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Head Ware house (Main
Block) Deptt
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Controlled office Copy No. 8
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Head Ware house ( External
Block) Deptt
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Controlled office Copy No. 9
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Head Engineering Deptt
Deptt
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10.0
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REVISION
HISTORY
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S.No.
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Revision No.
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Effective
Date
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Reason for
Revision
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Details of
Change
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Authorized
By
(sign
& Date)
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