Standard Operating Procedure (SOP on SOP)

Standard Operating Procedure

SOP full name is “Standard Operating Procedure“.

Procedure for SOP:

  • It should Contain the below minimum requirement:
    • Identification of SOP
    • Format of SOP
    • Signing and Authorization
    • Objective
    • Scope
    • Responsibility
    • Definition
    • Procedure (Include Instrument Operation, Administrative procedure, QMS procedure, etc.)
    • Attachment List & Numbering System
    • Change History
    • Distribution List of SOP (Optional)


1. Identification of SOP:    

  • The user department must identify the need of the SOP. 
    1. The following are the reasons (but not limited to) for the preparation of a new Standard Operating Procedure or revision of an existing one:
    2. Introduction of a New procedure or system and Installation of a new Equipment/Instrument.
    3. Separation or merger of two or more SOP.
    4. Requirement of a change control document, deviation, or incident related to the current procedure going on.
    5. Compliance (Corrective and Preventive action) to audit observations.
    6. Upgradation of system or up-gradation impacts the current procedure.

2. Format

  • The header of the first page of the SOP must have the following details,


Prepared By:  

_____________________ (Name) _________________________ (Sign/Date)  

Checked By:  

_____________________ (Name) _________________________ (Sign/Date)    

Approved By:

_____________________ (Name) _________________________ (Sign/Date)    


<Format No.>                                                                               
  • Name of company
  • Title: The brief heading of SOP                                
  • Department: Name of the department who is the owner of the procedure.

For Example:

  1. QA: Quality Assurance
  2. FD/PR: Formulation or Production
  3. AD/QC: Analytical or Quality Control
  4. WH: Warehouse
  5. IT: Information Technology
  6. ADM: Administration
  7. HR: Human Resources                                             
  8. SOP No.: The number assigned to the SOP and its current version number.
  9. Allocation of the SOP identification number is as mentioned;



  • AA     : Represents department code
  • SOP   : Indicates abbreviation for Standard Operating Procedure
  • CCC  : Numerical characters representing the serial number of the SOP for that department starting from 001, 002 … 999 in increments of one unit;
  • XX     : Represents the version number starting with “00” and continuing serially in increments of one unit.                                 
  • Page No.: Write as X of Y


  • X   : Represent sequential page number
  • Y   : Represent total number of pages.

  • Effective date:  Effective date shall be in DD/MM/YY format. For example, if the SOP is made effective on 15th January 2012, it should be as 15/01/22. The SOP shall be made effective by QA post-SOP training.
  • Review date: The date before which the SOP must be reviewed (One day prior to two years from the effective date). For example, if the SOP is made effective on 15th January 2022, review date should be stamped as 14/01/24.
  • Except first page onwards, the header must be in the following format.     
  • Effective date and review date only to be mentioned in first page of SOP.
  • The footer shall be common for all pages of SOP and shall contain format no. on the bottom left corner of each page, and contain “Prepared By/Date” and “Reviewed By/Date”.
  • Page orientation may be portrait/landscape, whichever is required.
  • The SOP must have subheadings and details as mentioned below:

3. Signing and Authorization:

  • Prepared by: Write here the name, signature, and date of the person responsible for writing the SOP and preparation of related formats.
  • Reviewed by: Write here the name, signature, and date of the person responsible for reviewing the SOP and its related formats. The Head of the user department/designee/QA should review the SOP.
  • Approved by: Write here the name, signature, and date of the person responsible to authorize the SOP and its related formats. Head Quality Assurance/designee should approve the SOP. In lieu of Head QA, Unit Head will be responsible for approval.
  • Objective: This section shall mention the intended use and applicability of the SOP.              
  • Scope: This section shall mention the purpose for the application of the particular SOP in the concerned departments and sections and where the said SOP is going to be implemented.
  • Responsibility: This section shall include the designation of the person/persons along with their specific responsibility towards the implementation of the objective of the SOP.
  • Definitions: Definitions of technical or scientific terms used in the Standard Operating Procedure should be included under this section for easy understanding of the procedure.
  • Procedure: This section shall include the operation procedure in clear, unambiguous and easy to understand sentences. All process checks, their frequency, recording and monitoring must be clearly defined. These procedures shall be explained in different subsections (as 6.1, 6.2, 6.3…etc. and further sections of these subsections as 6.1.1, 6.1.2 and so on and so forth) in the SOP.
  • References: Must include the details of any references used in order to design the system. The references can be an official publication, any published literature, guideline instruction manual, SOP etc.

4. Abbreviations:

  • Abbreviations of all the important acronyms used in the SOP must be written at the end.

5. Attachments:

  • Enlist all the attachments to the SOP. Attach all supportive documents with SOP in order to achieve consistency in the system. Any flow chart or pictorial representation of any process etc. can be included in attachment.
  • In case of definitions, references, abbreviations and attachments are not used, “None” shall be mentioned in respective sections.
  • In addition to above-mentioned topics, some SOP may have additional headings or subheadings depending upon the topic, scope and extent of SOP. E.g. Precautions, if any.
  • Format No.: The following alpha-numeric numbering system should be followed for various departments, which consists of seventeen alphanumeric characters inclusive of SOP number. i.e.



  • AA     :Represents the department of the respective SOP;
  • SOP   :Indicates abbreviation for Standard Operating Procedure;
  • CCC  :Represents numerical characters representing the serial number of the SOP for that department starting from 001, 002, 999 in increments of one unit;
  • F        :Denotes  the  format;
  • ZZ      :Represent  the  serial  number  of the  format starting from  01, 02  ……99;
  • XX     :Represents the version number of format starting with “00” and continuing serially in increments of one unit.
  • For e.g.  The first format for the first QA SOP shall be numbered as QA/SOP/001/F01-00.
  • Below is the format of the Attachment:
Attachment of SOP

6. Change History:

  • The Change history of the document and its subsequent revisions shall be captured. Any change in SOP/format shall be chronologically recorded.
  • The attachment shall be a part of the SOP but shall not be considered in total no. of pages of the SOP and shall be updated as and when there are any revisions made to the SOP or its attachments.
Change History of SOP
standard operating procedure template

The common point throughout the SOP:

Sr. No.ObjectRemarks
1Header spacing0.8” inches
2footer0.0” inches
3Border spacing on the left hand0.8” inches
4Border right-hand side0.6” inches
5FontTimes New Roman
6Font Size12
7TableNot Less Than 10 font size
8Paper SizeA4
9Page No.Must be X of Y
10SignatureAs per JD and Should be full sign

7. Preparation and Approval of SOP

  • The personnel performing or involved in the activity shall prepare the SOP.
  • All SOPs will be written in clear, unambiguous, easy to understand and easy to follow English language.
  • However, the SOPs, which are to be followed by the persons who cannot understand English language, shall be written in their local/Vernacular language. It shall be described in the form of Attachment.
  • The sentences should be small, clear and instructive in nature for each step.
  • The text matter in body shall be written in “Times New Roman” font style having a font size of ‘12’ and section heading in Bold.
  • The contents of the Table included in the SOP can be in Times New Roman with font size not less than 10. The foot note in the table or SOP can be in Times New Roman with font size not less than 10.
  • All signatures must be made in blue ball ink and dated in DD/MM/YY or DD-MM-YYYY format. For example, 29th May 2018 should be written as 29/05/18.
  • When required, for better understanding pictorial diagrams, pictures or screenshots shall be the part of SOP.
  • Manual correction in controlled copies by any individual is not allowed.
  • If any supporting SOP or attachment is to be referenced in any SOP, then only the SOP no. or attachment no. should be mentioned without exact version number.
  • Version number should be mentioned as XX. In such case, the current version of the referred SOP or attachment shall be considered. e.g. The reference will be given as QA/SOP/001-XX.
  • When the SOPs/attachments are made “OBSOLETE”, relevant document number also should be made obsolete and must not be allocated to any other existing or new document.
  • Any SOP written by the user at initial stage shall be called as “DRAFT SOP”.
  • The draft copy should be circulated to relevant departments for review and comments.
  • Upon receipt of draft copy, the reviewer should review and add suggestions, (if any) on the SOP.
  • The final copies of SOP and formats should be printed on A4 size of paper and designated person should mention the name, sign and date in “Prepared by” and “Reviewed By” & Approval section.
  • This copy should be forwarded to Head Quality Assurance or designee for approval along with the soft copy of the same.

Authorization and issuance of SOP:

  • Quality Assurance Head or Designee should approve this copy by reviewing the relevant change control no. (if any) and compliance to requirements of this SOP.
  • The approver should mention the name, sign and date in the “Approved by” in Signing & Approval section. 
  • After the SOP is approved, quality assurance personnel should destroy the draft copy.
  • QA will stamp each page of the SOP as “MASTER COPY” in red ink on the upper right corner of the page.
  • QA Stores all Master SOPs along with the soft copy of the same SOPs and should be accessed by only authorized QA person and Unit Head.         
  • Make photocopy of each authorized master SOPs and stamp “CONTROLLED COPY” in green ink on the Top middle of each page. Issue the controlled copy to the concerned departments.
  • Complete the “Document issuance and retrieval record” and take the signature of the concerned person at the time of issuance in the “Issued to” column.
  • SOP is a controlled document and its circulation is restricted. Only authorized and controlled copies shall be referred to and implemented.

Training on the SOP:

  • SOP training shall be imparted to the persons responsible for execution; the training shall be impart for newly prepared SOP as well as any revision in the current SOP.
  • After approval of the SOP, training should be conducted either by user who has prepared the SOP and signed as “Prepared By” or by Department head or designee who has reviewed the SOP and signed as “Reviewed By”.
  • The personnel involved in the signing of the SOP are considered as a trained.
  • Training of SOP shall be made effective after successful training to the concern.

8. Revision of existing SOP

  • The user shall raise a change control once the change in SOP is identified and change control number should be entered into the change history column of the SOP along with the summary of all changes.
  • Once the Change control is approved from QA, the user should print a Draft copy of the SOP. The draft copy should be circulated to relevant departments for review and comments.
  • Upon receipt of draft copy, the reviewer should review and add suggestions (if any) on the SOP and send it to the user department to incorporate the same in the SOP.
  • The SOP must be reviewed once in every two years from its effective date or as and when required whichever is earlier. The responsibility of revising the Standard Operating Procedure lies with the user department.
  • QA shall share the list of all SOPs that are to be reviewed to the user department prior to its forthcoming review date. The user department shall review the SOPs and if any change is not proposed then they shall inform well within advance to QA.
  • QA shall then, retrieve all controlled copies issued to relevant departments, and stamp the “REVIEWED” stamp on the first page of master and controlled copies. The user department and QA shall sign and date on the stamp and the same controlled copies shall be returned to respective department.
  • However, after two years of the review date of the reviewed SOP, it shall be mandatory to revise the SOP through a new version and mentioning review done in the summary of changes under change history.
  • The stamp of “REVIEWED” shall contain “REVIEWED ON”, “NEXT REVIEW ON”, “REVIEWD BY/DATE” and “APPROVED BY/DATE”. The stamp of “REVIEWED” must be in green ink at bottom middle of first page.
  • Other than the review if any revision is required in the SOP or the Attachments, it must be routed through a change control.
  • The revision of the SOP and its attachments is independent to each other. i.e. if there is a need for revision in SOP only, then the attachments need not be revised and vice versa. Any changes made to the SOP or Attachments shall be captured in the change history.
  • Upon revision, the validity of the SOP should be extended for next two years from the effective date of the SOP.
  • The revision of SOP should preferably be completed on or before the review date.

Retrieval of SOPs/Attachments

  • While issuing the new version of any SOP/Attachment, QA acknowledges the retrieval and destruction of the old version controlled copies and record the same in the “SOP Issuance & Retrieval Record” with the sign / date.                                 
  • QA will supersede the Master copy and related Attachment by stamping on all the pages with a stamp as “SUPERSEDED” in red ink in the top middle of each page. QA will retain the “SUPERSEDED” copy.                    
  • If the SOP/ Attachment are to be discontinued, fill the Change control form and take approval of Department Head, QA Head and Unit Head or Operation Head.        
  • Retrieve the controlled copies of document and take the signature/date of the QA person receiving the documents in the (Document issuance and retrieval record) . Destroy all controlled copies.
  • Stamp the Master document as “OBSOLETE” in red ink in the top middle of each page. QA will retain the “OBSOLETE” copy. The document reference number should not be allotted to any new SOP/Attachment.
  • All superseded and obsolete master versions of SOPs are to be chronologically filed and stored separately by Quality Assurance.

 Preparation of Uncontrolled copies of SOPs:

  • These are copies of SOPs made by photocopying the “MASTER COPY” for reference purposes only.
  • They are provided to regulatory or certification authorities for their reference purpose. Such copies must be made by the designated QA person with the knowledge and consent of the QA Head and stamped in blue ink as “UNCONTROLLED COPY” on Top middle of each page.
  • The company takes no responsibility to provide updates of these.               
  • Any soft/ scanned copy (given for reference purpose) bearing no stamp on the SOP sent inside or company shall not be under the scope of QA department and the issuance or retrieval of such copies shall not be accounted by QA.
  • Generation and distribution of unauthorized copies of the SOP by any means such as printouts, photocopies etc. are strictly prohibited.

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