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

SOP for SOP in Pharmaceutical Industry

1.0 OBJECTIVE :
  • To describe a procedure for preparation, review, approval, authorization, control and revision of Standard Operating Procedures.
2.0 SCOPE :
  • This SOP is applicable to all departments.
3.0 RESPONSIBILITY :
  • 3.1 Officer and above of user department are responsible to initiate the preparation of SOP.
  • 3.2 Quality Assurance department is responsible for implementation of this SOP.
  • 3.3 Head/Designee of user department is responsible to check the SOP.
  • 3.4 Quality Assurance Head or above is responsible to approve the SOP.
4.0 ACCOUNTABILITY:
  • QA Head
5.0 PROCEDURE :
5.1 Identification of 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.
5.2 Layout of SOP:
  • 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.
5.3 Header of SOP:
  • 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.
CodeDepartmentCodeDepartment
ENGEngineeringPRDProduction
HRDHuman ResourceQADQuality Assurance
QCDQuality ControlWHDWare House
FDDFormulation & DevelopmentITInformation Technology

  • The Unique Section code provided for different activities are as per below table.
CodeSectionCodeSectionCodeSection
GENGeneralEQPEquipmentMICMicrobiology
MEQManufacturing EquipmentUEQUtility EquipmentPEQPreventive Maintenance of Equipment

5.7 Format (layout):
  • Each format should have header and footer.
  • In header of format draw table having five rows and four columns.
  • Keep page margin Normal.
  • The header of Format 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 format. Use Capital “Arial Rounded MT Bold’’ with font size of 16 for (Company Name) and 13 for (Address).
  • Department
    • Write name of the department to which format pertains in Capital letters in left side column.
    • Use Capital “Arial Rounded MT Bold” font with size “10” For department name.
  • Title
    • Write down descriptive and clear title of format, indicating nature & object.  
    • Put Title on the middle of the second column of the header of the format. Use Capital “Arial Rounded MT Bold” font with size “10” For Title.
  • Effective Date
    • Keep this space blank on the right hand side of first row of the format to put effective date manually.
    • Effective date will be assigned 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).
  • Supersedes
    • Put Supersedes on the Right hand side of second row of the header of the format.
    • Superseded is given to indicate the previous revision of format.
    • Write “NIL” when the format is new or prepared for first time as there is no previous revision. Write “00” when the revision no.1 of the format is prepared & write “01” when the revision no. 2 of the format is prepared and so on.
  • Review Before
    • Put Review Before on the right hand side of the third row of the header of the SOP.
    • Review Before indicates the validity of current format.
    • Use Small “Arial Rounded MT Bold” font with size “10” For Review Before.
    • Use date format as Month and year e.g. September 2020.
  • Authorized By
    • This space should be kept blank for manual signature of the person who will authorize the format.
  • Page No.
    • Put Page No. on the right hand side of the fifth row of the header of the format. 
    • 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 format.
    • e.g.: In Page No. 1 of 10, 1 indicates the first page of format & 10 indicates the total page nos. of format.   
  • Footer of Format
    • Put Format No. at right side corner of the footer of the format.
    • Use small “Arial Rounded MT Bold” with size “10” For Format No.
5.7 Numbering of format
  • Use Capital “Arial Rounded MT Bold” font with size “10” For format Numbering.
  • Use unique alphanumeric system for numbering of format.  Use alphabetical abbreviation of department followed by section code (as appropriate), followed by serial number starting from 001 followed by F, serial number of format, followed by hyphen “-” and sequential version number of that format starting with 00. XXX/YYY/ZZZ/FAA-BB. For e.g. QAD/GEN/001/F01-00.
  • Refer point no. 5.6 of this SOP for department code and unique section code.
5.9 Preparation, Control and Issuance of the SOP
  • Draft the SOP using MS Word as per the procedure.
  • Take out the print of the SOP using A4 size paper.
  • If any suggestions are indicated by Department Head / Designee, carry out the same & send the DRAFT copy to QA Head and above for final approval.
  • After approval on “DRAFT” from QA Head and above, user department should take final printout of the SOP on light yellow colored papers of A4 size. Name & Designation with the Sign & Date details are filled under the Prepared By column by the person who prepares the SOP with the date of preparation.
  • This SOP is forwarded to Department Head / Designee for reviewing.  After reviewing, the Name & Designation with the Sign & Date details are filled under the Reviewing By column by the person who review the SOP with the date of reviewing.
  • This SOP is forwarded to Production Head / QA Head for final checking except Quality control SOP. Quality Control SOP is checked by QC Head.  After checking, the Name & Designation with the Sign & Date details are filled under the Checked By column by the person who check the SOP with the date of checking.
  • User department should transfer the signed copy to QA Head and above for the final Approval.
  • The Name & Designation with the Sign & Date details are filled under the Approved By column by QA Head and above the date of approval.
  • At the time of receiving the hard copy from user department, the QA department takes soft copy of the respective SOP from the User department & stores it in QA Computer under respective department folder & deletes the soft copy from the User department computer for the documentation control.
  • After approval of QA Head and above, Quality Assurance department put stamp on the SOP as per the below described procedure using the standard stamps.
  • Put a stamp of  “MASTER COPY” with the green ink on left side of top above company logo of each page, while making SOP.
  • Take out photocopy of the “MASTER COPY” & put a stamp of “CONTROLLED COPY” using violet colour ink on all pages of the SOP below format no. in right side of SOP.
  • User department should send a requisition to Quality Assurance department for requirement of SOP for display purpose.
  • Prepared the additional “CONTROLLED COPY” using violet colour ink on the right bottom side of all the pages of the SOP.
  • Take a photocopy of “MASTER COPY” & put stamp “UN-CONTROLLED COPY” using red  colour ink in the right bottom side of all pages of the SOP, which are given to outsider of company like FDA, factory inspector etc.
  • Take a photocopy of the master format and put stamp WORKING COPY SIGN:  DT. using green colour ink on all pages of the format below for Format no. in right side bottom of format.
  • Put a stamp of “OBSOLETE COPY” with red colour ink in the center of all pages of the “MASTER COPY” of the superseded revision & stored in Quality Assurance department for reference purpose only.
  • MASTER COPY of SOP of all departments is kept in Quality Assurance department in safe custody under lock & key. Access of the same is limited.
5.10 RETRIEVAL OF SOP
  • For the New SOP or the documents which are prepared & distributed for the first time that is for Revision No. “00”.
  • When SOP is revised and made effective, respective department must retrieve all the controlled copies of supersedes SOPs.
  • From the time of the distribution of First revision & onwards, the QA department first retrieve the superseded revision of the respective document & then only issue the new revision of the document.
  • Recover Superseded documents directly from the relevant department before issuing revised SOP in the case of revision.
5.11 REVISION
  • Review Standard Operating Procedures on or before 3 years as per review date mentioned on the SOP.   
  • Give new revision number, effective date and description of change in space provided, in case of revision of SOP.   
  • In case there is updation only in the Annexures (Format, Table, Checklist or in the Label ) & no change in the SOP content, then only change the Annexures (Format, Table, Checklist or the Label) & allocate the next revision number by following the Change Control Procedure. Also if there is updation only in SOP & not in the Annexures (Format, Table, Checklist or in the Label), then only change the SOP & allocate the next revision number by following the Change Control Procedure. 
5.12 DESTRUCTION
  • Retain all SOP (Obsolete copies) for 5 Years.
  • Destroyed all retrieve “CONTROLLED COPY” of SOPs by any one of the following method & maintained the destruction record.(Refer SOP No. QAD/GEN/006)
  • SOP Index : Prepare separate SOP index for each department as per Annexure 3.
  • Note: QA person should use black ball pen and other department person should use blue ball pen for documentation / Signature.
6.0 ABBREVIATIONS:
AbbreviationExpanded form
SOPStandard Operating Procedure
QAQuality Assurance
Annex.Annexures
No.Number
e.g.Example
mmmillimeter
&And

7.0 ANNEXURES
Annex .No.Title
01Template of SOP
02Template for Format
03Template of SOP Index
04 Stamps Specification

8.0 SOP REFERENCES
  • WHO-GMP guidelines
9.0 DISTRIBUTION OF SOP:
Control Copy No.Department

10.0 SOP REVISION HISTORY RECORD:
RevisionDetails for changeEffective date

END OF THE SOP


ANNEXURES :

Annex. No. 01 Template of SOP


Annex. No. 02 Template for Format


Annex. No. 03 Template of SOP Index


Annex. No. 04 Stamps Specification