Preparation, review, approval, distribution control, revision, retrieval and destruction of standard operating procedure – SOP (SOP for SOP)

• User department should identify the need of SOP.
• Following are reasons (but not limited to) for the preparation of new SOP or revision of existing SOP.
  • Introduction of new product, process, procedure,
  • Introduction of new equipment or instrument or system,
  • Separation or merger of one or more SOPs,
  • Addition of new system or revision of exiting one,
  • Requirement of a change control procedure,
  • Compliance (Corrective and preventive action) to audit observation.

• All SOPs must be written and prepared as per Annexure 1 (Template of SOP).
• All SOPs should be written in English language. (SOPs may be written in local language wherever applicable in addition to their English version).
• Each SOP should have header and footer on every page.
• Each header should have ‘Company’ logo on every page.

• In header of SOP draw table having three rows and three columns. Further divide those three rows into six rows.
• Keep page margin Normal.
• The header of SOP should contain the following:
• Name, Location & Logo of the Company
  • Put Logo of the company on left hand side of the A4 size paper of the SOP. Use Capital “Arial Rounded MT Bold’’ with font size of 16 for (Company Name) and 13 for (Address).
  • Put Name & Location of the company in the first row. Use “Arial Rounded MT Bold’’ with font size of 10.
  • Put “STANDARD OPERATING PROCEDURE” in Capital “Arial Rounded MT Bold” font with Size 12 in the second row.
• Title
  • Write down descriptive and clear title of SOP, indicating nature & object.  
  • Put Title on the middle of the third row of the header of the SOP. Use Capital “Arial Rounded MT Bold” font with size “10” For Title.
• Department
  • Write name of the department to which SOP pertains in Capital letters in right side columns.
  • Use Capital “Arial Rounded MT Bold” font with size “10” for department name.
• SOP No.
  • Put SOP No. on the right hand side of the second row of the header of the SOP.
  • Use Capital “Arial Rounded MT Bold” font with size “10” for SOP Numbering. Use unique alphanumeric system for numbering of SOP.   
• Supersedes
  • Put Supersedes on the Right hand side of third row of the header of the SOP.
  • Superseded is given to indicate the previous revision of SOP.
  • Write “NIL” when the SOP is new or prepared for first time as there is no previous revision. Write “00” when the revision no.1 of the SOP is prepared & write “01” when the revision no. 2 of the SOP is prepared and so on.
• Effective Date
  • Keep this space blank to put effective date manually after completion of training of SOP.
  • Effective date will be assigned by QA Department after completion of training on respective SOP.
  • Use date format as DD.MM.YYYY, where DD indicates the date; MM indicates the Month and YYYY indicates the year (e.g. 01.01.2018).
• Review Before
  • Put Review Before on the right hand side of the fifth row of the header of the SOP.
  • Review Before indicates the validity of current SOP.
  • Use Small “Arial Rounded MT Bold” font with size “10” For Review Before.
  • Use date format as Month and year e.g. September 2020. Review all SOPs at least once in three years as per review date.
• Page No.
  • Put Page No. on the right hand side of the sixth row of the header of the SOP. 
  • Use “Arial Rounded MT Bold” font with size “10” For Page no.
  • Page No. is given to indicate the individual page no. & the total no. of pages of SOP. e.g.: On Page No. 1 of 10, 1 indicates the first page of SOP & 10 indicates the total nos. of SOP.   

5.4 Footer of SOP

• Divide footer into 5 columns and 5 rows.
• Prepared by
  • Put Prepared by on the second column of the footer of SOP.
  • Signature, Date, Name & Designation of the person will be written manually under the Prepared by heading. Use “Arial Rounded MT Bold” font with size “10” For Prepared By.
  • The Prepared By indicates the details like Name & designation of the person who prepares the SOP & date of preparation of the SOP.
• Reviewed by
  • Put Reviewed by on the third column of the footer of SOP.     
  • Signature, Date, Name & Designation of the person will be written manually under the Reviewed by heading. Use “Arial Rounded MT Bold” font with size “10” For Reviewed By.
  • The Reviewed By indicates the details like Name & designation of the person who Reviewed the SOP & date of reviewing of the SOP.
  • The SOP Reviewing will be carried out by the Head/Designee of the User department who has the knowledge & experience to review the activity cover under SOP.
• Checked by
  • Put Checked by on the fourth column of the footer of SOP.
  • Signature, Date, Name & Designation of the person will be written manually under the Checked by heading. Use “Small Arial Rounded MT Bold” font with size “10” For Checked By.
  • The Checked By indicates the details like Name & designation of the person who checked the SOP & date of checking of the SOP.
  • The SOP checking will be carried out by the QA Head /Production Head except the Quality control department SOP. Quality control SOP is checked by Quality control Head.
• Approved by:
  • Put Approved by on the fifth column of the footer of SOP.
  • Signature, Date, Name & Designation of the person will be written manually under the Checked by heading. Use Small “Arial Rounded MT Bold” font with size “10” For Approved By.
  • The Approved By indicates the details like Name & designation of the person who approve the SOP & date of approval of the SOP. The SOP approval is done by Quality Assurance Head or above.
• Format No.:
  • Put Format No. below the Approved by Column of the footer of the SOP.
  • Use small “Arial Rounded MT Bold” with size “10” For Format No.
  • Use Format No. serially & department wise by using the “Unique code” system provided for identification to each department & also for different activity of department by considering the SOP number to which the format belongs.

5.5 Content of SOP

• Apart from Header & Footer the SOP contain the following information covers under the following headings as per given sequence: (Refer Annexure 1)
• OBJECTIVE
  • The Objective indicates the purpose or the activity of the SOP.
  • Use Capital “Arial Rounded MT Bold” font with size “10” For Objective heading & for the information given under the Objective heading.
• SCOPE
  • The Scope indicates the applicability of Machine(S)/ Equipment(S)/ Instruments (S)/ Utility(S)/Area (S)/ SOP.
  • Use Capital “Arial Rounded MT Bold” font with size “10” For Scope heading & for the information given under the Scope heading.
• RESPONSIBILITY
  • The Responsibility indicates the person or the department who is responsible to follow & to Implement the respective SOP.
  • Use “Capital Arial Rounded MT Bold” font with size “10” for Responsibility heading & for the information given under the Responsibility heading.
• ACCOUNTABILITY
  • The Accountability indicates the head of the department or above is accountable for the respective SOP.
  • Use Capital “Arial Rounded MT Bold” font with size “10” for Accountability heading & for the information given under the Accountability heading.
• PROCEDURE
  • The Procedure indicates the respective activity in detail.
  • Use Capital “Arial Rounded MT Bold” font with size “10” for Procedure heading & for the information given under the Procedure heading.
• ABBREVIATIONS
  • List all the Abbreviations with expanded form in a table one side short form and other side expanded form.
  • It includes 2 columns named “Abbreviation” and “Expanded form”. Fill the columns with necessary details.
  • Use Capital “Arial Rounded MT Bold” font with size “10” for Abbreviations heading & for the information given under the Abbreviations heading.
• ANNEXURES
  • The Annexure indicates the Number of Formats or Records connected with the SOP.
  • It includes 2 columns named “Annex. No.” and “Title” fills the columns with necessary details.
  • Use Capital “Arial Rounded MT Bold” font with size “10” for Annexure heading & for the information given under the Annexure heading.
• SOP REFERENCES
  • The Reference indicates the guidance from books, literatures, publishing, operating / maintenance manual etc. used for the preparation of the SOP.
  • Use Capital “Arial Rounded MT Bold” font with size “10” for Reference heading & for the information given under the Reference heading.
• SOP REVISION HISTORY RECORD
  • The Revision History indicates the Revision carried out in that particular SOP.
  • It includes 3 columns named “Revision”, “Detail for change” and “Effective date”. Fill the columns with necessary details while inducing the new SOP.
  • Use Capital “Arial Rounded MT Bold” font with size “10” for SOP Revision History Record heading & for the information given under the SOP Revision History Record heading.
  • Note: END OF THE SOP: Use capital “Arial Rounded MT Bold” font with size 10 for END of the SOP.

5.6 Numbering of SOP

• Put SOP No. on the right hand side of the second row of the header of the SOP.

• Use Capital “Arial Rounded MT Bold” font with size “10” For SOP Numbering.

• Use unique alphanumeric system for numbering of SOP.  Use alphabetical abbreviation of department followed by section code (as appropriate), followed by serial number starting from 001. Separate department, section, sequential no. by slash “/” and at least revision no. of SOP by hyphen “-”e.g. XXX/YYY/ZZZ-AA.
• The Unique code provided to every department are as per below table.

• The Unique Section code provided for different activities are as per below table.