SOP on Standard Operating Procedure : Pharmaceutical Guidelines

SOP on Standard Operating Procedure

Standard operating procedure to write a standard operating procedure in Pharmaceuticals.

1.0  Purpose:

       To describe the procedure for Preparation, Review and Approval of Standard Operating Procedures.

2.0  Scope:

       This procedure is applicable to all SOPs.

3.0  Responsibility:

Executive/Officer QA/Designee                  
: Preparation and Revision / Periodic review        
  of SOPs.
QA Head / Designee:
:  Review and Training of SOP.
Site Quality Head/GM-works/
: Approval of SOP

4.0  Procedure:

4.1  All SOP’s shall be as per the SOP Format, attached as Annexure 1.
4.2  Each page including Annexure shall bear company logo.
4.3  All the SOPs shall consist of Header, Content and Footer Part.
4.3.1  The Header part of each SOP shall remain common for all pages excluding format & Annexure pages. The Header part of the SOP shall consist of the following:    Standard Operating Procedure:
STANDARD OPERATING PROCEDURE shall be printed in Times New Roman letters. Font Size: 14, Style: Bold, Capital.  Title: The title of SOP shall be in Times New Roman letters. Font Size: 12, Style: Normal, Bold Sentences Case. It should be self descriptive.  Copy No.: The copy no. shall appear on all the pages of SOP except Master copy.  Block for Stamping Purpose: This Space shall be used for putting stamp for controlled documents on the photocopies.  Department: The name of the department preparing the SOP shall be in Times New Roman letters. Font Size: 12, Style: Bold, Regular.  Page No:
The page number shall appear on the right hand corner of the header. This specifies the page number, with respect to the total number of pages of the SOP, excluding the Annexure.  SOP No.:                    
Numbering of SOP: SOP number shall consist of 16 characters.
·  First two characters, 'XYZ' denotes "XYZ Limited ".
·  Third character denotes site, eg.XYZ for XYZ Plant. (Refer Annexure 2)
·  Fourth character denotes Slash (/).
·  Fifth and sixth character denotes Department or Section code. eg. QA for Quality Assurance, PR for Production, WH for Warehouse. ( Refer Annexure 2 )
·  Seventh character, denotes slash (/)
·  Eight ,ninth and tenth characters, denotes "SOP''
·  Eleventh, Twelfth & Thirteenth characters denotes serial number of SOP, starting from "001"onwards.
·  Fourteenth character denote dash (-).
·  Last two characters denote Revision No of SOP.
e.g. First new SOP of QA shall have SOP number as XYZ/QA/SOP001-00  Supersede: In case of a new SOP, Supersede No. will be Nil. If Revision of SOP is done than the previous SOP No. will be written against Supersede.  Effective Date:
The effective date is the Date from which the SOP shall be effective. Training shall be given to all concerned personnel before effective date of the SOP.  Review Date: This is the Date, before which the SOP shall be reviewed. Every two years from the effective date, SOP shall be reviewed. In case any need arises, SOP shall be reviewed, before the defined review period through a change control procedure.
QA shall assign a review date, two years from the effective date.  Prepared by: Person preparing the SOP from the initiating department, shall sign with the date, in black ink. Designation shall be printed with Department, mentioned in Annexure-2  Reviewed by: Head of the initiating Department/Designee shall review the SOP and sign with date, in black ink. Designation shall be printed with Department, mentioned in Annexure-2  Approved by: Site Quality Head and his designee shall approve all SOPs of Quality Assurance and Quality Control department. Site Quality Head and concerned Department Head shall approve all SOPs of other departments. They will sign with date in blue ink.
4.4  Content Part:
4.4.1  All SOPs shall contain the following sections:
i)  Purpose
ii)  Scope
iii)  Responsibility
iv)  Procedure
v)  Revision log
vi)  Abbreviations
vii)  Annexures
The details of the seven sections shall be as follows:  Purpose:
This section shall describe the justification for the preparation of the SOP and what is expected from it.  Scope:
This section shall indicate the applicability of the SOP for its intended use.  Responsibility: This section shall indicate responsibilities of the personnel for the intended activity.  Procedure:
This section shall cover stepwise activities performed and conditions / precautions required for implementing the SOP. 
· SOP text shall be written in simple and clear language in Font Style, "Times  New Roman", with a Font size of ‘12’ and space between the lines shall be 1.5 lines. A4 size white paper shall be used for printing.
· Bold letters shall be used for Heading and / or Subheadings.
· All the signatures and date shall be in black ink except signature of approval.
· All SOP shall be written in English language.
· Frequency : The frequency of operations shall be mentioned in the procedure if applicable.
· References : References shall be mentioned in the procedure if applicable. Revision Log: Revision Log shall have following details:

Revision No.
Effective Date
Reason  Abbreviations: The Abbreviations used in the SOP shall be described in this section.  Annexures:
· Annexure shall be formats, used for recording the data, related to the activity.      
· Annexure shall have a unique format number linked to the relevant SOP and shall be written at the bottom, left of the page.
· Copy of an Additional Format taken from other SOPs shall be attached as Annexure, which has a linkage or bearing on the said SOP. The same shall be indicated in the list of Annexures.
4.5  Footer Part:
The format number used for preparing the SOP is mentioned in the footer block. The font size of the format no. shall be in Times New Roman Font :10, Style: Regular. The format numbering system shall be as follows: Format number shall consist of total sixteen characters This format number shall appear on all the SOPs.
· First two characters 'XX' denote Company Name.
· The third character ‘B’ denotes the manufacturing Site. ( Refer Annexure 2 )
· Fourth character represent, "Slash" (/)
· Fifth & sixth character denotes the name of the Department or Section. (Refer Annexure 2)
· Seventh, eighth and ninth characters denotes SOP number of respective department to which the format is linked.
· Tenth character is "Slash" (/).
· Eleventh character is ' F', which stands for format.
· Twelfth and thirteenth characters represent sequential number to format, starting with '00' onwards.
· Fourteenth character denotes dash (-)
· Fifteenth and Sixteenth characters represent Revision Number of the format.
If a format is made for the first time it is indicated as “00” in the Revision No and     
subsequent revisions in the format shall be indicated by “01”, "02", and so, on.
e.g.: XYZ/QA001/F01-00
Where, “XYZ” represents XYZ Plant, “QA” represents the  “Quality Assurance”, 001 is the SOP number to which the format is linked, “F”  represents the “Format”. “01” represents the Format No. Followed by dash (-) and “00” indicates the revision number, i e new format.

Related: SOP on SOP

5.0  Revision Log:

Revision No.
Effective Date

6.0  Abbreviations:

Expanded Form
Standard Operating Procedure
General Manager
Quality Assurance
Quality Control

7.0  Annexure:

Annexure 1 : SOP Format
Annexure 2 : List of Codes for Site & Department
                                                                     SOP FORMAT
Copy No.:
Page No.:
SOP No.:
Effective Date:
Review Date:
Prepared By
Reviewed By
                  Approved By
Signature & Date

1.0  Purpose:
2.0  Scope:
3.0  Responsibility:
4.0  Procedure:
5.0  Revision Log:
6.0  Abbreviations:
7.0  Annexures:
Site Name
Department Code
Quality Assurance
Quality Control
Microbiology Laboratory
Stability and Validation Laboratory
Production (General)
Production (Tablet)
Production (Liquid)
Production (Capsule)
Information Technology
Production Planning & Inventory Control
Human Resource Management

Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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