SOP For STANDARD OPERATING PROCEDURE | Standard operating procedure sample

1.0       OBJECTIVE

1.1       To lay down the procedure for Standard Operating Procedure.

2.0       SCOPE

2.1       This procedure applies to Quality Assurance and Quality Control Department of xyz.


3.1       QC chemists and QA executives to prepare and follow the SOP.

3.2       Head – QA & QC for implementation of SOP.

4.0       PROCEDURE                       

4.1     All SOPs shall be prepared in Micro Soft. Word in “Arial” and font size “11”.

4.2       All SOPs shall be printed on A4 size sheets only.

4.3       First Page

4.4       Header Information

4.4.1    Margins and alignments for Header and Footer are as follow:

                 Top – 1”, Bottom – 1”, Left – 1” Right – 0.6”

                  Header – 0.5”, Footer – 0”

4.4.2    Header bears the name of the company “XYZ” in “Arial”, “Bold” and font size “14” 

4.4.3    The right side of the header displays a table with following information in “Arial” font size “11”.

4.5       Footer Information

4.4.4    The top of page shall read as STANDARD OPERATING PROCEDURE in “Arial”, “Bold” and font size “11” in Centre alignment.

4.4.5    TITLE: The title of the SOP explains the name of the SOP in Capital, “Arial”, “Bold” and font size “11”.

4.5.1    Document Number of SOP shall be given in the left side and page no. is on the right side in the footer.

4.7     Document Approval: The SOP should have the following details on the end of first and last page.

4.8       First and Other Pages of SOP

4.8.1    INDEX: Sop shall start with an index and it should contain all the steps written in that SOP.

4.8.2  CONTROL HISTORY: Control history shall contain the details of change control and the reason for that. This part shall be numbered as 0.0.

4.8.3    OBJECTIVE: This part of SOP describes the details of title of SOP and numbering of this title shall be “1.0”.

4.8.4    SCOPE: This part of SOP describes the details to which department the SOP shall be applied. The numbering of this title shall be “2.0”.

4.8.5    RESPONSIBILITY: This part of the SOP defines the responsibility for the preparation and implementation of SOP. The numbering of this title shall be “3.0”

4.8.6    PROCEDURE: This part of SOP shall start with numbering “4.0” in the SOP. The operational part of SOP shall start with this number. Further numbering for procedure shall be 4.1, 4.2 & so on and subpart for each numbering shall be 4.1.1, 4.1.2 etc. All the recording formats shall be recorded on Annexure or Appendix at the end of SOP. Annexure shall be numbered using Roman Numerals as I. II. III and so on. ABBREVIATIONS: This part of SOP shall be at the end of the procedure or calibration. This part shall define the short forms written in the SOP. REFERENCE: At the end of SOP reference shall be given.

4.9       SOP Numbering For SOPs The SOP numbering shall be given to all SOPs. The numbering system shall have 13 to 14 characters. First three characters shall be “ALL” for each SOP. The characters “ALL” are the characters of Company name “xyz”. Fourth character shall be “/“for all SOP’s and next three characters are “SOP” and it denotes that it is Standard Operating Procedure. Eighth character shall be “/“for all SOP’s and next two or three characters shall represents its department code that is shown in Table 1. After department code eleventh character shall be “-“. Last two characters (12th to 13th) shall be the sequence number of the SOP in a department. A typical example of numbering in the QA department shall be as follows The SOP number for “Standard Operating Procedure on SOP” shall be ALL/SOP/QA-01

4.10     Code Numbering For Document

4.10.1  The code numbering shall be given to all SOPs in the plant. The numbering system shall have 16 characters.

4.10.2  First 13 characters remain same as SOP numbering for SOP.

4.10.3  14th character shall be “/“for and last two characters “00” shall be the revision number of that SOP.

4.10.6  A typical example The code of document number for QA SOP shall be ALL/SOP/QA-01/00 and it shall be at the left side of the footer.

4.11     Code Numbering For Recording Format (ANNEXURE)

4.11.1  The format numbering shall be of 17 characters.

4.11.2  First three characters shall be “ZYz” for each SOP. The characters “XYZ” are the characters of Company name “XYZ”.

4.11.3  Fourth character shall be “/“and next two or three characters shall be department code.

4.11.4  Seventh character shall be “/“and next two characters shall be the SOP number to trace that to which SOP this format belongs to.

4.11.5  Tenth character shall be “/” and next character “FR” shall represent the “Format”.

4.11.6  Twelve and thirteen character represents the format number. Next character shall be “-” and last two characters shall be “00” to represent the revision number of that SOP and Format.

4.11.7  The format number shall be positioned at top of the page on right, in bold and shall be like XX/QA/01/FR01-00 in all formats of that SOP.

4.11.8  All the formats used for recording purpose shall be “ANNEXURE” and “APPENDIX” with the SOP and shall be controlled by the Quality Assurance Department. Appendix shall not be numbered, as it shall be a part of SOP.

4.12    Preparation, Distribution, Retrieval and Destruction of Sop

4.12.1  QA / QC department shall prepare all the new & revised SOPs of QA, QC, Microbiology, Production and store Department. HR department shall prepare SOP’s of Human Resources.

4.12.2  After approval of SOP, it should be stamped as ‘Master copy’ in red and photocopied for distribution and shall be stamped as ‘Controlled Copy’ in blue.

4.12.3  The controlled copy shall be issued on the effective date of the respective SOPs and at the same time controlled copy (ies) of the superseded SOP shall be retrieved and destroyed immediately by the concerned QA personnel / QC personnel.

4.12.4  Document Distribution:

Document is to be distributed in the specific department / departments where ever the need and the no. of copies, signature of the authorized person of that particular department and signature of the person who is distributing the SOP, retrieving the previous SOP and destroying the control copy of SOP shall be recorded on the format of Annexure I i.e. ALL/QA/01/FR01-00. The original copy shall be treated as Master Copy and shall be in the custody of Quality Assurance Department.

4.12.5  The master copy of superseded SOP shall be stamped as “OBSELETE” in red at middle of each page of SOP and preserved for minimum five years from the effective date of the next version.

4.12.6  SOP shall be reviewed after every two years or if any change required in the SOP, whichever is earlier.

4.12.7  A change control shall be raised if there is any change, for a revision of SOP.

4.12.8  A change control shall not be required if the revision is periodic.

5.0       ABBREVIATION   

            SOP    :           Standard Operating Procedure

            QA       :           Quality Assurance

            QC      :           Quality Control

            HR       :           Human Resources

            PR       :           Production

            ST       :           Store

            No.      :           Number

6.0       REFERENCE: NIL

Operation and calibration of Bursting Strength Tester.


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