I. PURPOSE
To describe the Standard Operating Procedure for
Preparation, Review, Approval, Distribution and Retrieval of Standard Operating
Procedure.
II. SCOPE
This SOP is applicable to the SOPs of all the departments at
APL, Unit-V.
III. RESPONSIBILITY
Assistant,
Executive and Dy.Manager – QA
IV. ACCOUNTABILITY
Head – QA
V. PROCEDURE
1.0 Preparation
1.1
The person who performs the activity, prepares the SOP
in consultation with the department head.
1.2
Prepare the SOP as per the Format No.:
F01/SOPQA001-00.
1.3
SOP should be in simple language and can be converted
into local language,
if required.After
preparation, draft should be taken on A4 size executive bond paper and stamped as ‘DRAFT FOR REVIEW’.
1.4
Stamp the first page of the SOP draft print with
‘REVIEWED BY’.
1.5
The Department Executive or higher level reviews the
SOP for its completeness and correctness and signs under the reviewed by stamp
with date.
1.6
Finally, Head QA approves the SOP.
2.0 Master copy of SOP
2.1 The SOP should be taken on A4 size
executive bond paper having Aurobindo logo
on the top right corner.
2.2
Write the text matter in ‘Times New Roman’ with font
size ‘12’.
2.3 The
spacing between the two lines must be 1.5.
2.4 Under
‘PROCEDURE’, numbering should be given as follows
2.4.1
Number the 1st point as 1.0, the sub point
of the 1st point as 1.1, and
the sub point of 1.1 as 1.1.1 and so on.
3.0 SOP should contain the following
3.1 PURPOSE
3.1.1
It describes the purpose for writing the SOP.
3.2 SCOPE
3.2.1
It specifies the limit and applicability of the SOP.
3.3 RESPONSIBILITY
3.3.1
Persons who is associated with the implementation of
the SOP.
3.4 ACCOUNTABILITY
3.4.1
Person ensuring the correct implementation of SOP.
3.5 PROCEDURE
3.5.1
This includes the instructions to be followed in a
sequential order.
3.6 REVISION
SUMMARY
3.6.1
This includes the reason and history of review.
3.7 END OF THE DOCUMENT
3.7.1
Indicates end of the SOP.
Note : It must also contain the List of Formats or
List of Annexures before the Revision summary as per the requirement.
4.0 SOP
Numbering
4.1
All SOPs must have a unique number consisting of five
characters of alphanumeric system as described below.
XX -
YYY
Sequential number 
Department
code
4.2
Department code
4.2.1
It is a two digit alphabet as given below.
|
S. No.
|
Department Name
|
Dept. Code
|
|
|
Quality
Assurance
|
QA
|
|
|
Quality Control
|
QC
|
|
|
Microbiology
|
MB
|
|
|
Production
|
PR
|
|
|
Process and Development
|
PD
|
|
|
Warehouse
|
WH
|
|
|
Engineering & Utility
|
EU
|
|
|
Human Resources & Administration
|
HR
|
|
|
Safety
& Environment
|
SE
|
4.3 Version
Number
4.3.1
All the SOPs are given a version number as given below
|
S. No.
|
Version
|
Number
|
|
01
|
First Issue
|
00
|
|
02
|
Second issue
|
01
|
|
03
|
Third issue and so on….
|
02 and so
on…
|
Example: QA001-00
Where ‘QA’
indicates ‘Quality Assurance’
department, ‘001’ is the serial number of SOP and 00 indicates
version number.
5.0 Format numbering
4.1 Format number should be given at the
bottom right corner of the format with font 8.
4.2 Numbering should be given as follows
Example :
F01/SOPQA001-00
Where F01 indicates 1st
Format, QA001 indicates SOP number and 00 indicates version number.
Note: For
labels, version should be given for format in Format number,where as for
SOP it is not required.
Example:
F01-00/SOPQA030
5.0 Annexure
numbering
5.1 The title is followed by the annexure
number.
Example : AX01/SOPQA001-01
Where AX
indicates Annexure, 01 indicates sequential number, QA001 indicates SOP number
and 01 indicates version.
6.0 Signing of
SOP
6.1 The person who prepares the SOP,
must sign under the ‘PREPARED BY’ along with
date.
6.2 The user department Executive/ Asst
Manager should sign under the
‘REVIEWED
BY’ along with date.
6.3 The
user Department Head should sign under the ‘APPROVED BY’ along with date.
6.4 Head
QA/Deputy should sign under the ‘APPROVED BY’ along with date.
6.5 Incase
of QA SOP’s, Head QA and Deputy must finally sign under ‘APPROVED BY’ along with date.
7.0 Distribution of SOPs
7.1
Stamp the original copy of SOP as ‘MASTER COPY’.
7.2 Photocopy
should be stamped as per the given table and issued to the respective locations
as per the requirement.
|
Stamp Name
|
Location of stamping |
Issued to |
|
“CONTROLLED COPY”
(Green colour)
|
Bottom right side
corner
|
User Dept.
|
|
“REFERENCE COPY”
(Red colour)
|
Bottom right side
corner
|
Work Place of user
Dept.
|
|
“UNCONTROLLED COPY”
(Blue colour)
|
Bottom right side
corner
|
Outside of APL
Unit – V
|
|
“OBSOLETE COPY ”
(Red colour)
|
Across the text
|
To be archived in
QA dept.
|
|
“MASTER COPY”
(Red colour)
|
Top left side corner
|
To be archived in
QA dept
|
|
“DRAFT FOR REVIEW”
(Red colour)
|
Across the text
|
User Dept.
|
|
“REVIEWED BY”
(Blue colour)
|
Right side middle
of the document
|
User Dept.
|
|
“CANCELLED”
( Red colour)
|
Across the text
|
To be archived in
QA dept
|
7.3 Ensure that “CONTROLLED COPY”, and
“REFERENCE COPY” are not photocopied further.
7.4 In
case of cancellation of SOP, withdraw all the distributed copies from the individual
departments, destroy them, and the “MASTER COPY” should be stamped as
“CANCELLED” and this SOP number can be allotted for any other SOP.
7.5 If the SOP is revised, withdraw all the
distributed copies of previous version, destroy them, and ‘MASTER COPY’ should
be stamped as ‘OBSOLETE COPY’.
7.6 QA
must record the distribution details of the SOP in
Format No.:
F02/SOPQA001-00.
7.7 The SOP index should be maintained as per
Format No.: F03/SOPQA001-00.
8.0 Revision of SOPs
8.1 SOP
should be revised every 3 years or as and when it needs revision.
9.0 Calibration procedures and Validation procedures should be prepared per the formats given in list of formats.
‘
9.0 List of Formats
|
Format No.
|
Title
|
|
F01/SOPQA001-00
|
SOP Format
|
|
F02/SOPQA001-00
|
Document Control
Record
|
|
F03/SOPQA001-00
|
Index
|
|
F04/SOPQA001-00
|
CP Format
|
|
F05/SOPQA001-00
|
VP Format
|
VI. REVISION SUMMARY
|
Version No.
|
Revised on
|
Reason for Revision |
|
00
|
NA
|
NA
|
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