1
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Purpose:
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To lay down the procedure
for preparation of Standard operating Procedures.
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2
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Scope:
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This SOP is applicable
for preparation of Standard Operating Procedures for all the employees/departments
of xxxxx (insert the name of the
organization and location).
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3
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Responsibility:
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Department
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Responsibility
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User Department
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It is the responsibility of each user Department Head to initiate
preparation, authorization, training (to concerned personnel) and
implementation of the SOP.
It is also the responsibility of the user department to ensure the
presence of the current version of the SOP in the Department.
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Quality Assurance
Department
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QA department is
responsible for review and authorization of the SOP.
Archiving of master copy
and issuance of control copy as per the request.
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4
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Abbreviations:
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4.1
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SOP
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Standard Operating
Procedure
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4.2
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QA
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Quality Assurance
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4.3
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RF
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Record Form
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5
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Definitions:
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5.1
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Attachment:
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An approved designed
layout attached to an SOP for better understanding of the procedure (flowchart,
drawings, P&IDs etc) or having space for data entry (recording the
activity).
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5.2
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Controlled Copy:
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A copy of original
document (Master Copy) which is controlled as per document control procedure.
A controlled copy stamp is used to differentiate such copy from other copies
and traceability. These copies are subject to retrieval as per document
control procedure.
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5.3
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Master Copy:
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When a document is
authorized and signed in blue ink is called master copy. In SOP a master copy
stamp is used to control all the master copies and differentiate them from
other documents.
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5.4
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Standard Operating
Procedure:
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Standard operating
procedures (SOPs) are the detailed written instructions that specify how a
test or administrative procedure is to be performed, or how a piece of
equipment is operated, maintained and calibrated. SOPs describe the
"standard" approved procedures that are routinely carried out in a
GMP facility.
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5.5
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Uncontrolled copy:
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A copy of original document
(Master copy) which is not subject to document control procedure. An
Uncontrolled copy stamp is used to differentiate such documents from other
documents.
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6
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Procedure:
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6.1
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SOP shall be prepared for all the operations,
activities to be performed and instructions followed in xxxxx (insert the name of the organization and location).
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6.1.1
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Creation of SOP:
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6.1.1.1
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For all the new projects the SOPs shall be
created as per the Project Quality Plan.
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6.1.1.2
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For existing project any new SOP shall be created
following a change control procedure justifying the need of new SOP. The
change control number shall be mentioned in the History column of the SOP.
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6.1.1.3
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New SOP shall be drafted as per the instructions
given below and printed with a watermark stating DRAFT # on every page of the
SOP across the text matter.
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6.1.2
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Review, Approval and
Authorization of SOP:
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6.1.2.1
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Draft copy shall be circulated for review and
comments to concerned departments.
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6.1.2.2
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The reviewer shall review and mark
corrections/suggestions, if any on the SOP and send it to user department for
incorporation.
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6.1.2.3
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The user department shall incorporate the
comments or suggestions in the SOP in consultation with Head of the
Department.
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6.1.2.4
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The Final copy of the SOP shall be printed in the
appropriate sized paper mentioned below by the user. The copy shall be signed
in the ‘prepared by’ columns of approval page.
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6.1.2.5
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This copy shall then be reviewed and approved by
the Head of the Department or his designee in ‘approved by’ column of the
approval page.
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6.1.2.6
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This copy shall then be forwarded to head of
Quality Department for review and authorization.
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6.1.2.7
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Head Quality Department shall review and
authorize the SOP by signing in the ‘authorized by’ column of the approval
page.
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6.1.2.8
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The Quality Department shall stamp the copy as
‘MASTER COPY’ on top right corner of the SOP.
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6.1.3
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Training of SOP:
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6.1.3.1
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After approval from Quality Head, the Quality
department shall make a photocopy of the SOP and stamp it as ‘TRAINING COPY’
in green ink at lower right corner of the SOP and send it to user department
for training.
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6.1.3.2
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The person who has prepared or approved the SOP
shall impart the training to the staff. A person designated by Head of
Department or Head Quality shall also impart the training, if needed. The
person who have already undergone the training and has approved training
record s can also impart training, if needed.
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6.1.3.3
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During the training the trainer shall ensure that
all the sections of the SOP are explained and understood by the trainees.
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6.1.3.4
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The user department shall complete the training
in 10 days from the date of approval and send the records along with training
copy to Quality Department.
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6.1.3.5
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The persons mentioned in training list are
considered to be trained in that SOP. Quality Department then destroys the
‘TRAINING COPY’.
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Note: In case of retraining or training of new
personnel, controlled copy can be used for training purpose.
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6.1.4
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Distribution and Filing:
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6.1.4.1
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Once the training is imparted the SOP shall be
dated with effective date and next revision date on approval page with blue
ink and issued to departments as per distribution list.
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6.1.4.2
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A photocopy of the master copy shall me stamped
as ‘CONTROLLED COPY’ with date and signature of the issuer. The record of
issuance shall be maintained as per SOP (Control of Documents).
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6.1.4.3
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Master copy shall be archived by Quality
Department in master file at secured location.
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6.1.5
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Changing SOP:
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Any change in the SOP (non typographical errors,
changes, additions) shall follow change control procedure as per the current
version of the change control SOP (Ref. no). However, typographical changes
or additions do not require a change control. The change shall be mentioned
in revision history column.
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6.1.6
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Revision of SOP:
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SOP shall be revised after every two years such
that the month of Next Review shall be exactly two years from effective date.
Tolerance of ± 1 month is allowed.
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SOPs are living documents and shall be updated as
necessary as the procedure change or reference document change or regulatory
requirements change.
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6.2
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Layout:
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All the SOPs prepared under ………….. shall have a
harmonized format and layout. SOP shall be prepared as per the following
scheme:
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6.2.1
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Formatting:
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6.2.1.1
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All the SOPs shall be prepared in A4 paper and
printed on single side. SOPs shall be appropriately stamped to differentiate
between Master, Control and Uncontrolled copies.
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6.2.1.2
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Page Setup shall be as
follows:
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Margins: Top: 0.8”, Bottom:
0.8”, Left: 1.0”, Right: 0.8”, Gutter: 0”, Gutter
Position: Left
Orientation: Preferably Portrait
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Font: Times New Roman, Font Style:
Regular, Font Size: 12, Font color:
Automatic
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Header: Header of all the pages
shall be same and shall have the following structure with formatting:
Header from top: 0.5”
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Content
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Formatting
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Company Name/ Logo
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Top of the document,
Center Aligned
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Document Category /Type
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1st row of the
Header, Times New Roman 12, All Caps, Bold, Center Aligned
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Department:
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2nd Row, Times
New Roman 12, Capitalize Each Word, Regular, Center Aligned
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Title:
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3rd Row, Times
New Roman 12, Sentence Case, Regular, Alignment Justified
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SOP No.:
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4th Row, Times
New Roman 12, Capitalized Each Word, Regular, Left Aligned
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Revision Number:
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4th Row, Times
New Roman 12, Capitalized Each Word, Regular, Left Aligned
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Supersedes:
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5th Row, Times
New Roman 12, Capitalized Each Word, Regular, Left Aligned
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Page number:
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5th Row, Times
New Roman 12, Capitalized Each Word, Regular, Left Aligned, in the
format of page X of Y, where X is page number and Y is number of pages.
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Footer: The footer of the SOP
shall contain the Form Number which is the number of the prescribed format in
which the SOP shall be prepared.
Footer from Bottom: 0.5”
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6.2.2
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Numbering: All the SOPs shall be
assigned a unique number. The number shall be assigned as follows:
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QA/001
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Where, QA stands for
department code i.e, Quality Assurance
001
stands for the number of SOP
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Wherever reference to
revision number is required the SOP number shall be identified with revision
number as:
QA/001, Rev.00
Rev.00 means the reference SOP QA/001 is of
Revision 00.
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Other Schemes for coding
can also be used, en example is provided in next post.
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6.2.3
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Department Code: All the departments
under xxxxx (insert the name of the organization) are assigned department
code as follows:
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Engineering :
EN
Human Resource and
Administration : HA
Bulk Production :
BP
Filling, Labeling and
Packaging : FP
Purchase Department :
PD
Quality Assurance : QA
Quality Control :
QC
Warehouse and Dispatch : WD
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6.2.4
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Approval Page:
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The approval page of the
SOP shall have the name, signatures and date of the following people with
their department and designation/ role in the department.
Prepared by: The person who writes
the SOP shall have relevant experience in that activity or field and shall
have knowledge of the organizational structure.
Reviewed/Approved by: The person who
technically reviews the SOP for completeness shall have a relevant experience
in the activity or the field and shall have knowledge of the organizational
structure.
Authorized by: The SOP after the review
cycle shall be reviewed by QA Department keeping in mind the regulatory
requirement and Quality Management System.
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Effective Date and Next
Revision Date: The effective date and Next review date shall be assigned by quality
assurance department and shall be filled by hand in blue ball pen ink. These
dates shall be assigned only after the training has been imparted to the
concerned personnel and training record evaluated. The date shall be filled
in DD.MM.YYYY format (D-Day. M-Month. Y-Year).
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6.2.5
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Revision: SOP shall be revised
after every two years such that the month of Next Review shall be exactly two
years from effective date. Tolerance of ± 1 month is allowed.
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6.2.6
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Text Pages:
The pages subsequent to Approval Page shall have uniform
contents as described below. Footer from bottom shall be 0.5”.
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6.2.7
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Contents:
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6.2.7.1
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The contents of the SOP shall be divided into 10
major headings. The contents of the technical and administrative SOP are
same, however and specific description required by a technical SOP, such as preparation
of solutions, reagents and other preparatory activity before the described
procedure shall be included under procedure.
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6.2.7.2
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The headings shall be consistent in all the SOPs
prepared under xxxx (insert the name of the organization) QMS. All the
headings shall be in Bold followed by colon and should have a fixed sequence.
Text description in the heading shall be written below the heading and all
the text shall be aligned as justified. If any of the heading is not relevant
to a particular SOP, ‘Not Applicable’ shall be written below the heading. Important
text which needs special emphasis shall be put as ‘Note’. The text of the
note shall be bold italicized and shall start after the colon following the
heading ‘Note’, e.g.,
Note: Note signifies important instruction which
require special emphasis.
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6.2.8
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Following is the indication of the text to be
written under each individual heading:
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6.2.8.1
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Purpose: This heading represents the question ‘why’
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why this procedure is written
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why it is being performed
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6.2.8.2
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Scope: This heading represents the question ‘when’ and ‘where’
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when this procedure needs to be
performed
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where these procedure applies
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sometimes it is prudent to
mention what is not within the scope of the SOP for making the SOP more
specific
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6.2.8.3
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Responsibility: This heading represents the question ‘who’
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who performs the procedure and
who sees it is performed correctly
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6.2.8.4
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Abbreviations: Under this heading all
the relevant abbreviations pertaining to the SOP in question are explained
for better understanding and representation of the procedure.
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6.2.8.5
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Procedure: The heading represents
the question ‘how’
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how to perform the procedure
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the procedures can be of two
types, administrative and technical. The technical procedure shall have
following subheadings
5.1 Precautions and Safety
5.2 Equipments
5.3 Materials and Reagents
5.4 Preparation of Solutions
5.5 Procedural Steps
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Procedure should be written in a
concise, step-by-step, easy-to-read format.
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The numbering shall be done using
a multilevel list for different headings and subheadings and for each step to
make them distinct. Where ever appropriate simple list and bullet points can
also be used.
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Subheadings may be used to divide
procedure in logical steps and text of such subheadings may be kept bold.
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The information presented should
be unambiguous and not overly complicated.
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The active voice and present verb
tense should be used. The term "you" should not be used, but
implied.
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The document should not be wordy,
redundant, or overly lengthy.
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Use diagrams and flow charts
wherever appropriate.
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It is recommended to give 6 point
space between different paragraphs.
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6.2.8.6
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Reporting: This section guides the
person performing the activity for reporting pre-activity, activity and post
activity operations. The section provide reference of the documents to be
filled such as log books, record sheets, BPR etc.
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6.2.8.7
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Attachments:
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SOP can contain the
following attachment which has specific function as follows::
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6.2.8.7.1
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Annexure are explanatory text/documents
given at the end of the procedure for better understanding of the procedure.
Annexure includes flow charts, diagrams, tables, formats or any other data
which is necessary for better implementation of the procedure.
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6.2.8.7.2
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Formats are special annexure
which provided template for preparation of a specific document such as SOP,
Specification, MFR, BPR etc.
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6.2.8.7.3
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Record Forms are used to record
pre-operation, operation and post-operation activity as well as provides
documented evidence with linkage and traceability for proper functioning of a
quality system. These filled records are necessary for proper functioning of
Quality System.
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6.2.8.7.4
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Annexure containing reference text required for
proper understanding and implementation of the SOP shall be placed first
serially followed by the formats and record forms. Annexure are not included
in page numbering system of the SOP.
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6.2.8.7.5
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Identification of Annexure
and Record Form:
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All the Annexure and Formats/Record Form shall
bear a unique number for uniformity, identification and traceability. The
number shall be printed in footer of the attachment and aligned left. Font
should be Times New Roman and font size 10. Record form number shall be
assigned as follows:
QA/001/00-AT001
Where, QA/001 stands for SOP number
00
stands for revision number of
document
AT stands for Attachment
001
stands for subsequent
number of record forms
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To differentiate Formats and Record Forms from
all other attachments, code AT is suffixed with RF followed by subsequent
number in the series such as:
QA/001/00-ATRF004
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6.2.8.7.6
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Format of all the annexure and
record forms shall follow the pattern given below.
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i.
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Header:
Header of all the pages shall be same and shall
contain company logo and name. Below the company logo and name annexure
number shall be given. When record forms and annexure are issued for
recording any information the annexure number shall be deleted. the following
with formatting:
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Contents
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Formatting
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Company Logo and Name:
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Top of the document,
Center Aligned
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