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1.0 |
OBJECTIVE |
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1.1 |
To lay down a standard
procedure for preparation, authorization, control, issuance, implementation,
review, change, and destruction of Standard Operating Procedure (SOP). |
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2.0 |
SCOPE |
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2.1 |
This SOP shall be applicable
for preparation, authorization, control, issuance, implementation, review,
change and destruction of Standard Operating Procedure (SOP) in Department of
Quality Assurance (QAD) and Animal House Facility (AHF). |
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3.0 |
RESPONSIBILITY |
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3.1 |
Head- QA |
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3.2 |
QA Personnel (QAP) |
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3.3 |
Head- AHF |
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4.0 |
DEFINITIONS |
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4.1 |
SOP: "Defined as detailed, written instructions to
achieve uniformity of the performance of a specific function". |
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5.0 |
PROCEDURE |
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5.1 |
Preparation of Standard Operating Procedure (SOP) |
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5.1.1
|
Write all the SOPs in unambiguous language, easy
to understand and easy to follow. |
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5.1.2
|
Prepare SOP in Microsoft word Version 2016. |
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5.1.3
|
Type the SOP content
specifically in Font Style: Times New Roman and Size: 12. Keep line spacing
to 1.5 lines. |
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5.1.4
|
All SOPs shall consist of Header, Content and
Footer Part. |
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5.1.5
|
Set the page margins as follows:
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5.1.6
|
The header and footer part of
each SOP shall remain common for all pages excluding format and annexure
pages. |
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5.1.7 |
Header of the SOP |
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5.1.7.1 |
Type the header of the SOP
specifically in Font Style: Times New Roman and Size: 11. |
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5.1.7.2 |
The Header part of the SOP
shall consist title of SOP, logo of organization, name of department, SOP no.,
version no., supersede no., effective date, review date, distribution to and
page no. |
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5.1.7.3 |
Insert a table in the header
containing four columns and five rows. |
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5.1.7.4 |
In first row, merge first three
columns and type TITLE in first column in bold and capital letters.
Mention the title of the SOP in capital letters in centre alignment. Start
the title of the SOP with the phrase “STANDARD OPERATING PROCEDURE FOR”
and then mention complete title of the SOP. |
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5.1.7.5 |
In second column of first row,
add logo of organization. |
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5.1.7.6 |
In second row, type DEPARTMENT
in the first column in bold and capital letters and mention the name of the
department to which the SOP belongs, in corresponding second column in
capital letters. In third column of second row, type EFFECTIVE DATE in
bold and capital letters and mention the corresponding date in fourth column. |
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5.1.7.7 |
In third row, type SOP NO.
in first column and REVIEW DATE in third column in bold and capital
letters. Mention corresponding SOP no. and review date in capital letters in
second and fourth column respectively. Write SOP number in capital letters as
mentioned under section 5.1.8. |
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5.1.7.8 |
In fourth row, type VERSION
NO. in first column in bold and capital letters and mention corresponding
version no. in the second column. Version no. shall be written as 00 for
first version, 01 for second version, 02 for third version and so on. In
third column of the fourth row, type DISTRIBUTION TO in bold and
capital letters and mention the department code to which SOP is to be
distributed in corresponding fourth column in capital letters. |
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5.1.7.9 |
In fifth row, type SUPERSEDE
NO. in first column and PAGE NO. in third column in bold and
capital letters. Mention corresponding supersede no. and page no. in capital
letters in second and fourth column respectively. |
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5.1.7.10
|
The header of the SOP must look
as per the Annexure for “Header of the SOP” (Annexure No.: A/SOP/QAD/001/01-00). |
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5.1.7.11
|
Version No.: Version No. consists of two numerical characters which
start from ‘00’ then after on each revision the number shall go on increasing
order i.e. 01, 02, 03… onwards. ‘00’ indicates the first issuance of that
particular SOP. |
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5.1.7.12
|
Effective Date: The effective date is the date from which the SOP is
scheduled to be effective. Training shall be given to all concerned personnel
before effective date of the SOP. Effective date shall be written as
DD/MM/YYYY. (e.g. 03/01/2015) after completion of training. |
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5.1.7.13
|
Review Date: The review period will be 3 years from the effective
date of the SOP. For example if any SOP is having effective date ‘03/01/2015’,
its review date will be ‘02/01/2018’. |
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5.1.7.14
|
Supersede No.: Supersede number is the SOP number of the previous
version of the SOP, i.e. if some SOP is revised then mention the SOP number
followed by previous version number of the SOP. In case of a new SOP,
Supersedes No. will be ‘Nil’. |
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5.1.7.15
|
Page No.: Mention page number of the SOP in A of B manner where A
is the page number and B is page count (total number of pages). |
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5.1.8 |
Numbering
system of the SOP |
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5.1.8.1 |
All SOPs shall be numbered as
per unique numbering system of 11 characters as below: |
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|
|
SOP/XXX/YYY |
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|
|
Where, First three characters are
“SOP” which signify
Standard Operating Procedure; 5th, 6th and 7th
characters are “XXX” which signify department code to
which SOP belongs i.e. QAD for Quality Assurance, AHF for Animal House
Facility; 4th
and 8th characters are slash (/); 9th ,10th and
11th characters are “YYY” which signify SOP number starting from 001. For example: Numbering
of the SOPs of AHF Department shall be SOP/AHF/001, SOP/AHF/002…and so on. |
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5.1.8.2 |
In case of new SOP creation,
SOP number for that new SOP shall be followed by next chronological number of
last number of listed SOP. |
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5.1.9 |
Content of the SOP |
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|
5.1.9.1 |
Write the contents of the SOP
in simple and easy to understand language. |
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|
5.1.9.2 |
All content sections of the
Standard Operating Procedure shall be typed using font style: Times New Roman
and font size: 12. |
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5.1.9.3 |
All lines of text matter shall
have 1.5 spacing between each line. |
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5.1.9.4 |
Type the section headings in
bold and capital letters with below mentioned numbering system. |
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5.1.9.5 |
The sections shall be serially
numbered as 1.0, 2.0….etc. The sub-sections coming under main section shall
be serially numbered as 1.1, 1.2…etc. The next level sub-sections coming
under sub-sections shall be serially numbered as 1.1.1, 1.1.2….etc. |
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5.1.9.6 |
In case of instrumental SOP,
prepare a draft copy of the SOP after installation qualification of the
instrument and finalize the SOP after result of performance qualification are
concluded. |
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|
5.1.9.7 |
The contents of SOP are covered
under nine headings with following numbering: 1.0
OBJECTIVE: The objective of the SOP is, to
describe the aim of the SOP. Start the objective of the SOP with the phrase “To
lay down a standard procedure” and then complete the objective of the SOP 2.0
SCOPE: Scope of the SOP is to
describe the implementation/applicability of the SOP in respective department
(s). Start the scope of the SOP with phrase “This SOP shall be applicable”
and end the scope of the SOP with the phrase “at Company Name, Location”. 3.0
RESPONSIBILITY: Responsibility describes the
designation of the person who is directly related to the task. Mention the
designation of the person performing the work in responsibility. 4.0
DEFINITIONS: This section describes all the
definitions / theory / fundamental related to corresponding SOP. If there is
no definition in the SOP, mention “Nil” under this heading. 5.0
PROCEDURE: This section describes the
operation or process in a stepwise manner. Mention all the checks to be
carried out, records to be maintained, frequency of the operations and
special precautions, if any. Write the procedure of the SOP in commanding
manner and not in suggestive language. 6.0
ENCLOSURE: Describes the list of the
formats / annexures inserted in the SOP under heading enclosure. Formats are used for
the recording the data related to the activity and are represented in tabular
form in centre alignment as shown below:
Annexures are used for
representation of all the reference diagrams, labels, tables, charts etc.
attached with the SOP. Mention annexures in a tabular form in centre
alignment as shown below:
If there is no Enclosure in the
SOP, mention “Nil” under this heading. Each Annexure as well as format shall
be given separate Annexure or Format number as explained in SOP No.:- SOP/QAD/….
(Current Version). 7.0
ABBREVIATIONS: This section shall include the
full form of the abbreviations, which are used in the respective SOP. If there is no abbreviation in the SOP, mention “Nil” under this heading. Type one abbreviation in one line and give sub-numbering to each abbreviation used in the SOP. 8.0
REFERENCES: Mention the list of references if used while preparing the SOP or that are linked to the SOP. If a reference is taken from websites then mention the complete web link as the reference.
If there is no reference in the SOP, mention “Nil” under this heading. If reference is designed in-house then mention “In-house” under the heading.
Type one reference in one line and give sub-numbering to each reference used in the SOP. 9.0
REVISION
HISTORY: Mention
the reason for changes made in the SOP with every revision if the SOP has been revised. In case of schedule revision, the change control number is not applicable. Mention the details of change control number and reason for changes
etc. in a tabular form as shown below:
|
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5.1.9.8 |
End the SOP with the sentence 'END
OF DOCUMENT' typed in Bold and capital letters with center alignment. |
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5.1.9.9 |
Prepare a draft copy of the SOP
and submit it to Quality Assurance Department along with all the Annexures or
Formats of the SOP as a draft copy. |
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5.1.9.10
|
After making necessary changes
and approval of the draft copy of the SOP makes the changes in soft copy and
destroy the draft copy by shredding or tearing off. |
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5.1.9.11
|
In case of any equipment-related SOP prepare a draft copy of the SOP before Operational Qualification.
Mention Operation procedure, Cleaning procedure, Preventive Maintenance procedure, and Calibration procedure in the draft copy of the SOP. |
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5.1.9.12
|
Prepare the SOP as per “Format
for SOP preparation” (Format No.:- F/SOP/QAD/001/01-00). |
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|
5.1.10 |
Footer of the SOP |
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|
5.1.10.1
|
Type the footer of the SOP
specifically in Font Style: Times New Roman, Font Size: 11 and bold letters. |
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5.1.10.2
|
Insert a table in the footer
containing four columns and five rows. |
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5.1.10.3
|
In the first row, keep first
column blank, in second column type PREPARED BY, type CHECKED BY
in the third column and APPROVED BY in the fourth column in bold and capital
letters. |
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5.1.10.4
|
In the second-row type NAME
in the first column in bold and capital letters and type names of persons in
the corresponding second, the third and fourth columns in bold letters. |
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5.1.10.5
|
In the third-row type DESIGNATION
in the first column in bold and capital letters, and type the designations of
the personnel corresponding to the second row in corresponding columns in
bold letters. |
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5.1.10.6
|
In the fourth-row type SIGN
in the first column in bold and capital letters and keep all other columns
blank. |
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5.1.10.7
|
In fifth-row type DATE
in the first column in bold and capital letters and keep all other columns blank. |
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5.1.10.8
|
The Footer of the SOP must look as
per the Annexure for “Footer of the SOP” (Annexure No.: A/SOP/QAD/001/02-00). |
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5.1.11 |
Special matters of the SOP |
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5.1.11.1
|
Special
matters of the SOP are Tables, Drawings, Pictures, Caution or Warnings, Flow
charts etc. |
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5.1.11.2
|
Give numbering to the above
mentioned special matters wherever these are inserted in the SOP. |
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5.1.11.3
|
Type the
title of the special matter inserted in bold letters along with the number of
the special matter applying center alignment. For example, if a table is
inserted in an SOP for the schedule of the cleaning, then the title should be
mentioned like this: Table – 1 Schedule for cleaning |
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5.1.11.4
|
Follow
the same procedure for all special matters included in the SOP. |
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5.1.11.5
|
Wherever a note is to be
inserted in the SOP, type the Note in bold letters, and do not give a serial
number to the Note. |
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5.2 |
Authorization of the SOP |
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5.2.1
|
All the SOPs are signed by
three persons i.e. Prepared by, Checked by, and Approved by. |
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5.2.2
|
The person, who is directly related to the work, prepares and signs the SOP for prepared by. SOPs are prepared by the user department. |
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5.2.3
|
The department head or his
deputy, of the person preparing the SOP, checks the SOP for correction and
signs for Checked by. |
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5.2.4
|
Head / Manager – QA signs the
SOP for approval by. Head / Manager QA checks the effect of the procedures mentioned in SOP on the quality aspects. It is the responsibility of the Head /
Manager QA to check the correlation of the procedures mentioned in the SOP
with the procedures mentioned in some other SOPs of the same or other departments. |
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5.2.5
|
Mention date along with while
signing the SOP in the corresponding column. |
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5.3 |
Control of the SOP |
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5.3.1
|
All the SOPs are controlled by
QA department. |
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5.3.2
|
Only QA department is authorize
to take the printouts of the SOP. |
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5.3.3
|
Take the print outs of the SOPs
on A-4 size papers and send to the respective department for signatures. After
final signature of “Approved By”, Stamp the SOP (including enclosures) for “MASTER
COPY” in green colored ink on the bottom left-hand side of every page
of the SOP. |
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5.3.4
|
Prepare only one Master Copy of the SOP and keep it in the QA custody. Do not staple the master copy of the SOP.
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5.3.5
|
After preparation of the Master
copy of the SOP update the Master List of the SOP of the concerned department as per format for the Master List of the SOP (Format No. F/SOP/QAD/001/02-00).
In case of SOP revision update the Master List of SOP within 30 days of issuance of the SOP. |
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5.3.6
|
Prepare the control copies of
the SOPs by taking Xerox of the respective Master copy for each department
mention to which SOP is to be distributed and stamp as ‘‘CONTROLLED COPY’’
in blue colored ink on the bottom of the right-hand side of each page. |
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5.3.7
|
For display copy of the SOP,
xerox the master copy of the SOP on A-4 size white-colored papers with water
mark “DISPLAY COPY”, meant to be used only for display copy prints of
the SOPs. Refer to the Annexure for “Papers to be used for Display Copy of
the SOP” (Annexure No.: A/SOP/QAD/001/03-00). |
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5.3.8
|
For an un-controlled copy of the
SOP, xerox the master copy of the SOP on normal A-4 white-colored papers.
Stamp on each page ‘‘UNCONTROLLED COPY’’ with red-colored ink in the center of the page diagonally. Note: Take all xerox in 100 % scaling i.e. 100 % the actual size of the master copy of the SOP. Do not xerox the control and display a copy of the SOP. |
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5.4 |
Issuance of the SOP |
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|
5.4.1
|
Issue the Controlled Copy and
Display Copy of the SOPs to the concerned department with issuance stamp on first
page of the SOP with details of Issued by, Issued to, Copy number and Date. |
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5.4.2
|
Make a record of all the copies
including uncontrolled copy prepared from Master copy of the SOP as mentioned
in Format for Issuance, retrieval and destruction record of the SOP (Format
No.: F/SOP/QAD/001/03-00). Keep the SOP issuance record with the Master copy
of all the SOPs. |
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5.4.3
|
Stamp ISSUED at the bottom of
the SOP in the center of the first page. |
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5.4.4
|
Refer to the specimen stamps as shown in Annexure for “Specimen stamps for SOP” (Annexure No. A.......................). |
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5.5 |
Implementation of the SOP |
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5.5.1 |
The implementation date of the SOP is the same
as the effective date i.e. the SOP is implemented on an effective day. |
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5.5.2 |
Issue the SOP prior to at least one or two
working days of the effective date of the SOP. |
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5.5.3 |
The SOP may be issued on the same day also in
case of emergency / urgent requirement. |
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5.5.4 |
Provide training to all concerned persons
before the implementation of the SOP. |
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5.5.5 |
Assess the persons on the basis of written
/ oral / mock examination. Personnel scoring 60 % or above marks may be considered to understand the contents and procedures mentioned in the SOP.
Allow only those personnel to perform the specific job who passed in the assessment. |
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5.5.6 |
Provide re-training to the personnel
scoring below 60 % marks and re-assess them. |
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|
5.5.7 |
Repeat the re-assessment till the
individual scores 60 % or above. |
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5.6 |
Review and Change of the SOP |
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|
5.6.1 |
Review period of the SOP is
three years. |
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|
5.6.2 |
If an SOP is to be changed
before review date due to some modification in facility, procedure or
mistakes etc., then change the SOP by filling a change control form as per
SOP for Change Control Format No.:-F…………………….. |
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|
5.6.3 |
Change control is not
applicable in case of schedule revision of the SOP. |
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|
5.6.4 |
After review of the SOP assign a new version number to the SOP i.e. next number from the previous number of the
SOP. For example after changing the SOP for the first time mention the revision/version number 01, after the second change mention 02 and so on. |
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|
5.6.5 |
In case of schedule review of
the SOP review within 30 working days of the review date of the SOP. |
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|
5.7 |
Destruction of the SOP |
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|
5.7.1 |
After review of the SOP collect all the
SOPs of the previous version and confirm with the issuance record of the SOP. |
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|
5.7.2 |
Destroy all the copies of the SOP except
Master Copy by tearing off or shredding the SOP(s). |
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|
5.7.3 |
Stamp OBSOLETE diagonally
in the center of the SOP in red-colored ink in Master copy. |
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|
5.7.4 |
Keep the Obsolete Master copy for the next five
years and destroyed after five years by tearing off or shredding the SOP. |
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|
6.0 |
ENCLOSURES |
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6.1 |
Formats |
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6.2 |
Annexures |
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7.0 |
ABBREVIATIONS |
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|
7.1 |
SOP-
Standard Operating Procedure |
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7.2 |
QAD-
Department of Quality Assurance |
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7.3 |
AHF- Animal
House Facility |
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8.0 |
REFERENCES |
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8.1 |
In-house |
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9.0
|
REVISION HISTORY |
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|
9.1 |
Nil |
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END OF DOCUMENT |
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