1.0 Objective:
To provide the
guidelines for writing Standard Operating Procedure (SOP) in this Pre structured
format and to assure that all Standard Operating Procedures follow the
guidelines specified in this SOP.2.0 Definition:
The Standard operating procedure as defined in this document, means a set of written instructions which define how a given activity or operation is to be carried out by the concerned operating personnel.
3.0
Scope:
Standard operating
procedures related to all department company. or Laboratory.4.0 Responsibility:
Quality
Assurance Officer/Manager:
Responsible for Preparation and
control the document as per guideline.
General Manager:
Responsible
for review the document thoroughly.
Director:
Approved the document
5.0
Procedure:
5.1
Assignment of numbers to SOPs
5.1.1
SOPs of all departments
shall be numbered as follows: XXX/SOP/001-00
Where, XXX = Company Name
SOP = Standard Operating Procedure
001 = Number of SOP
00 = Revision
Number
5.1.2 Any cross reference number
of SOP in SOP will be indicated by principal no only and it will be understood
that status of the SOP will be current SOP only.
5.1.3 Select the page A4 size and
set the page left side 1.0 inch and top, bottom, right side 0.7 inches. All the
fonts written in Times New Roman.
5.1.4 Page No. shall be mentioned
as number of the page of the total No. of pages. e.g. 01of
02, size ‘12’.
5.1.5 Effective
Date shall contain Date, Month and Year for e.g. 01.07.2006, size ‘12’.
5.1.6 Review Date shall contain Date, Month and
year for e.g. 30.06.2008, two years or earlier if specified from the Effective
Date, size ‘12’.
5.2 SOP HEADER TEXT: will be represented as follows:
Symbol
here
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NAME OF THE INSTITUTE (size '14 Capital bold letter)
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(FOR AUTHORISED USE ONLY)
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DEPARTMENT
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:
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SOP NO.
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: (size '12 Capital bold letter)
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TITLE:
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Effective
Date
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:
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Review Date
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:
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Page No.
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: (size '12 Capital letter)
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Issued
to
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:
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Copy No.
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(size '12 Capital letter):
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Supersedes No.
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: (size '12 Capital letter)
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5.3
Contents of SOP :
5.3.1 Title: The title of the SOP shall describe in short the activity to be
covered under the SOP i.e. whether the SOP refers to calibration, operation,
cleaning or any policy.
5.3.2 Objective: The
objective of the procedure or its purpose shall be clearly stated in imperative
form with reason for generation of the SOP.
5.3.3 Scope: The scope shall define the exact areas of operation covered by the
SOP.
5.3.4 Responsibility: The responsibility of implementing and execution shall be defined.
5.3.5 Procedure: The procedure will cover all the operations in a sequential manner
along with brief description of the system (if necessary).
5.4 Preparation of new SOP
draft:
5.4.1 Any new SOP shall be prepared by the
operating personnel (Research Officer) as per given format in Annexure – 1,
checked by the departmental head or QA department.
5.4.2
Department Head shall give this draft SOP
to QA after review.
5.4.3 QA shall review the SOP in detail and
finalize the draft after discussion with the GM or Director.
5.4.4
The
SOP shall be checked by concerned QA, approved by QAM/GM or Director.
The new SOP after duly signed
should be handed over to QA for necessary issuance.
5.5
Review
of SOP:
5.5.1
All SOPs are to be reviewed by QA after a specified duration of two
years.
5.6
Revision:
5.6.1
Revision before review
date:
5.6.1.1 Any revision in the SOP due to change in
procedure, change in system, modification in equipment or change in the
regulatory requirement, the originating department will make the necessary
changes with prior information to the QA.
5.6.1.2
For preparation and approval of revised
SOP follow step No.:5.4 to 5.5.
5.6.1.3 Record the reason for revision in
history of revision.
5.6.2
Revision on review date:
5.6.2.1 Wherever review is undertaken. Incase of
no change in SOP, the Reason for revision shall state periodical review. Ensure
that review is carried out once in two years or earlier if required.
5.7 Issuance &
Distribution:
5.7.1 In original copy all page stamped with
“MASTER COPY” in blue ink and get the required no. of copies for zerox. In all
zerox copy stamped with “CONTROLLED COPY” blue ink and issue as per requirement
from concerned department. Any copies other than those specified and issued,
shall not be available in any of the departments.
5.7.2 Number of copies of a particular SOP as
per the department’s requisition to QA shall be issued only as per its purpose
at the site of work along with a departmental copy for reference. Enter the
details of Issued copy as per given format in Annexure – 2.
at the time
of issue of the SOP by QA.
5.8 Retrieval &
Destruction
5.8.1 In case of revision of SOP, after
issuance of new SOP, department will return the obsolete one to Q.A.
department.
5.8.2 Prior to issue of a revised SOP, the previous
supersedes copy shall be withdrawn by QA from the concerned department, stamped
original copy as ‘OBSOLETE’ in red ink, other photocopies shall be destroyed by
QA
5.8.3 Keep immediate earlier versions of obsolete
copies in files and destroy the other versions.
6.0
Distribution:
Controlled
Copy No. 1 : QA department
Original
Copy : Manager Quality Assurance
7.0
Documents:
7.1 Annexure – 1 SOP Format XXX/FRM/001-03
7.2 Annexure – 2 Issued copy Details Format XXX/FRM/002-03
8.0 History of Revision:
Revision No.
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Effective
Date
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Revision
details
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Reason for
revision
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