SOP Of Writing Standard Operating Procedure (SOP) In Pharmaceutical Industry
SOP
Stand for Standard Operating procedure, it is a written procedure describing step
wise that how a process or task can be carried out.
1.0 Purpose
This
section of SOP shall define a procedure for writing
a Standard Operating Procedure and the expected outcomes of it.
2.0 Scope
This section
belongs to the preparation of SOP of the concerned department, site and plant,
and anywhere it is applicable.
3.0 Responsibility
This
section includes the designee i.e officers, senior officers, assistant mangers
and manager/ head of departments that are responsible for preparation,
revision, approval and authorization of SOP.
4.0 Accountability
This section includes Head of
Department and Head of QA that are accountable for the implementation of SOP.
5.0
Terms and
Definitions
This section includes
the explanation of terms and other unique contents which are not common and
cannot be easily understandable.
6.0
Precautions
This section defines
the safety measures that are to be taken when working as per the SOP to combat
any harm to health.
7.0
References
This section
includes the references that are used in the preparation of SOP, if no
reference is used write N/A.
8.0
Procedure
8.1
All
SOPs shall be as per the SOP format, must be simple, to the point, effective
and shall be written in Times New Roman format and printed on A4 size paper.
8.2
Heading
shall be write in font size 12 and Bold, Subheadings shall be write in font
size 11 Bold and General body shall be write in font size 11 normal format.
8.3
All
SOPs shall consist of Header, General Body and Footer.
8.4
All
the pages of SOP shall contain Header and Footer except Annexure, and shall
consist of the following
8.4.1
Logo
First
column of table shall contain Logo of the organization.
8.4.2
Organization Name
Second
column shall contain name of the organization in font size 14 and bold letter.
8.4.3
“Standard Operating Procedure” shall be
below organization name in font size 12 and bold.
8.4.4
Department
Name
of Department shall be written in bold letter and font size 12 below Standard
Operating Procedure.
8.4.5
Title
Title
shall be in in font size 12 and bold letter.
8.4.6
Page number
Page
number shall be write in the right corner of the table.
8.4.7
Effective date
Effective
date is the date from which SOP shall be effective.
8.4.8
Review date
Review
date is the date before which SOP shall be revised.
8.4.9
Supersede
If
the SOP is revised Supersede No. of SOP shall be written, in case of new SOP
supersede no is N/A
8.4.10 SOP
Number
SOP
numbering shall be as follow or as per in-house format
XY/QC/SOP/000
Here
XY denote organization code, QC denote department or section code ad here is
for Quality control department, SOP denote standard operating procedure code
and 000 denote numbering starting from 001
8.4.11 Prepared
by
This
column shall contain name of the person preparing SOP, designation, signature
and date.
8.4.12 Reviewed
by
This
column shall contain name of the person reviewing SOP, designation, signature
and date.
8.4.13 Approved
by
This
column shall contain name of the person approving SOP, designation, signature
and date.
8.4.14 Authorized
by
This
column contain name of the person authorizing SOP, designation, signature and
date.
8.5
General body of SOP
8.5.1
All
SOPs shall have following template containing following headings
8.5.1.1 Table
of contents
8.5.1.2
Amendment
History
8.5.1.3 Purpose
8.5.1.4 Scope
8.5.1.5 Responsibility
8.5.1.6 Accountability
8.5.1.7 Terms
& definitions
8.5.1.8 Precautions
8.5.1.9 References
8.5.1.10
Procedure
8.5.1.11
Abbreviations
8.5.1.12
Annexure
8.5.2
Table of content
Table
of content shall contain all the SOP content in tabulated form with serial
number and page number allocation
8.5.3
Amendment History
Amendment
history shall contain any amendment carried out in SOP, if no amendment occur
write N/A
8.5.4
Purpose
The
purpose of SOP shall define a procedure for writing
a Standard Operating Procedure and its expected outcomes of it.
8.5.5
Scope
The scope of SOP
shall indicate where this SOP is applicable.
8.5.6
Responsibility
Officers,
senior officers, assistant mangers and manager/ head of departments are
responsible for the intended activity of SOP.
8.5.7
Accountability
Manager
QA and Head of Department are accountable for implementation of SOP.
8.5.8
Terms & Definitions
This section includes the explanation of terms
and other unique contents which are not common and cannot be easily understandable.
8.5.9
Precautions
This section defines
the safety measures that are to be taken when working as per the SOP to combat
any harm to health and system.
8.5.10 References
This
section includes the references that are used in the preparation of SOP, if no
reference is used write N/A
8.5.11 Procedure
8.5.11.1 This section shall include step by step
illustration of any process or task that how it shall be carried out or
performed.
8.5.11.2 SOP shall be written in clear and
simple wording using present indefinite tense. Usually Font style “Times New
Roman” & font size 12 or 11 is used. A4 size page is used for printing.
8.5.11.3 Writing shall be step wise and
avoid long paragraphs.
8.5.11.4 Headings and sub-headings shall
be bold and numbering shall be given subsequently like ‘Headings’ shall be
allocated e.g. 1.0, 2.0, 3.0, ------------and so on, Sub-Headings shall be e.g.
1.1, 1.2, 1.3, ------- and so on, Further sub heading/points if needed,
numbering will be e.g. 1.1.1, 1.1.2------- and so on.
shall
be allocated e.g. 1.0, 2.0, 3.0, ------------and so on, Sub-Headings shall be
e.g. 1.1, 1.2, 1.3, ------- and so on, Further sub heading/points if needed,
numbering will be e.g. 1.1.1, 1.1.2------- and so on.
8.5.12 Abbreviations
This section shall
contain the abbreviations used in SOP.
8.6
Footer
8.6.1
Footer
of SOP shall be present on each page of SOP.
8.6.2 It shall
contain Copy right or controlled information.
8.6.3 Usually font size 10 or 8 is used
8.7
SOP codes allocation
Each
department shall have the following codes that will be used for allocation of
code numbers to an SOP.
Production
General PR
Production
Tablet PT
Production
Liquid PL
Quality
Assurance QA
Quality
Control QC
Ware
House WH
Environment
Health & Safety ESH
Engineering EN
Purchase PU
Information
Technology IT
Human
Resource Management HR
9.0
Annexure
Annexure shall be formats used for recording the data related to SOP.
Annexure 1
|
Logo |
Organization Name Standard Operating Procedure Department |
Document
Number |
|
|
Revision
Number |
|||
|
Date
of Effectiveness |
|||
|
Date
of Review |
|||
|
Supersede
No |
|
||
|
Page
No |
|
||
|
Title: |
|||
|
Prepared
by |
Reviewed
by |
Approved
by |
Authorized
by |
|
Name:___________ Designation:_______
Signature:_________
|
Name:______________ Designation:________
Signature:_________ |
Name:____________ Designation:_______
Signature:_________ |
Name:____________ Designation:________
Signature:__________ |
|
Date
: |
Date
: |
Date
: |
Date:
|
1.
Purpose
2.
Scope
3.
Responsibility
4.
Accountability
5.
Terms
& definitions
6.
Precautions
7.
References
8.
Procedure
9.
Abbreviations
10. Annexure
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