SOP Title: Preparation of standard operating procedures
- Objective:
To define procedure for the preparation of Standard operating Procedures and to bring about uniformity in the documentation system while writing/preparing SOP’s for different operations/procedures that are being followed in different departments within the organisation.
- Scope:
This procedure is applicable to all the SOP’s throughout the organisation during preparation, revision and should be followed every time during documentation.
- Responsibility:
Assistant Manager, Executive, Officer, Chemist – Quality Assurance
- Accountability:
Head – Quality Assurance
- Procedure:
- All the SOP’s are to be prepared on the basis of actual working process including with the clear instructions to be followed:
All SOPs will be prepared in Font: Times new roman.
Each SOP has a Header, Footer, Body and Border.
Header: Contain Company logo, Company Name (Font style: Bold, font size 22), Address of the company (Font style: Regular, font size 12), Department name (Font style: Bold, font size 18), Standard Operating Procedure (Font style: Bold, font size 18), Title (Font style: Bold, font size 16), rest contain (Font style: Regular, font size 12) with header border.
Footer: present at the bottom of all pages of SOP and includes signature, date, name and Designation block of Prepared By; Checked By and Approved By (Font style : Regular, font size 12) .
Body: Should contain the subject matter. (Font style: Regular, font size 12, line spacing 1.5 lines) and heading and heading No. (Font style: Bold, font size 12), Paper size A4, Printing one side.
- All SOP’s should be made as per the format enclosed and should cover the following details:
Company logo
Company Name
Address of the company
Department name
SOP Name / Title
SOP Number
Version No.
Supersedes (SOP No.)
Effective Date
Next Review
Page No.
Objective
Scope
Responsibility – Department / Personnel
Accountability
Procedure
Abbreviation
Annexure
Revision History
- Every SOP would bear the initials of the following personnel:
Prepared By – Originator
Checked By – Respective department head or responsible person
Approved By – Head QA
- SOP Number :
The SOP’s should be numbered as described below:
Department code / Serial Number code refer below example:
Department
Quality Assurance : SOP’s applicable to Quality Assurance department should be abbreviated as ‘QA’.
Quality Control : SOP’s applicable to Quality Control department should be abbreviated as ‘QC’.
Production : SOP’s applicable to the Production department should be abbreviated as ‘PD’.
Engineering : SOP’s applicable to the Engineering department should be abbreviated as ‘EG’.
Warehouse : SOP’s applicable to the Warehouse department should be abbreviated as “WH”.
Human Resource : SOP’s applicable to Human Resource department should be abbreviated as ‘HR’.
Purchase and Accounts : SOP’s applicable to the purchase and accounts departments Should be abbreviated as ‘PA’.
SOP Number for QA: QA/001; QA= Quality Assurance , 001= SOP Serial No. and same for other department.
Format Number for QA: QA/001/F01/R00 QA= Quality Assurance , 001= SOP No., F01=Format Serial No. and R00=Revision No. and same for other department.
QA will be assigned SOP No. after getting, after receiving requisition for new SOP number allotment (having all the details like: Requisition For New SOP Number Allotment , To:, From, Date of requisition, Sr. No., Name of SOP, SOP Number, Reason for request, Requested by:, Sign & date, HOD: Sign & date and Received by: Sign & date) from concern department.
- Version:
The first time the SOP is made the revision status starts from 00 indicating the SOP is made for the first time. But any SOP revised for the first time will be given the revision number 01.
- Effective Date:
It is the date on which the SOP is effective. The date format should be:
DD/MM/YYYY – where DD indicate the date; MM indicate the Month and YYYY
indicate the Year.
- Page Numbering:
It is like X of Y, where X – represents the current page no. and
Y – Represents the total no. of pages.
- Supersedes SOP:
The superseding SOP number should be the same one before the version. If the SOP is made for the first time the superseding SOP will be nil.
e.g. SOP Number: QA/001 Effective Date: 01/01/2024 Version: 00 Supersedes: Nil
If the same SOP is revised, then the SOP number will not change. Effective date will change and revision no. will increment by 01 no. :
e.g. SOP Number: QA/001 Effective Date: 01/01/2026 Version: 01
Supersedes: QA/001-00
- Next Review:
All SOP’s should be reviewed at least once in two years preferably in the month of due date or before if there is a change in procedure, process, place or equipment with proper validation record.
The date format should be in month- year e.g. mm/yyyy
If no revision required in SOP after two years then same SOP will be extended one time for next two years, after one time extension SOP will be revised.
Extension table will be only on first page of the SOP.
- Contents of the SOP:
Objective:
A brief description stating what the SOP covers and why it is made.
Scope:
This would give the details to whom, the SOP is applicable to.
Responsibility:
A brief description of the responsibilities of each department / personnel’s who are responsible for implementation of SOP against their designation or department name.
Accountability: Head of the department or designee or QA.
Procedure:
It should include all steps required by the process in a proper sequence & instructions to be followed while carrying out the activity as to achieve the desired goals. It should be user friendly, easy to understand and written in plain simple English language.
Abbreviation :
Procedure should include the list of abbreviations used and their full form.
Annexure:
Any format and attachment.
Revision History:
After review the SOP’s should be maintained with and revision number in the revision history at the end of SOP. Last five revision history to be maintained in history table.
Quality Assurance department should be responsible for compiling all the SOP’s in consultation with the concerned department personnel.
The corrected & approved SOP should be printed on A4 size paper.
Approval:
All SOPs will bear the following initials: (Name, Designation and sign & date)
Prepared By – Originator
Checked By – Respective department head or responsible person
Approved By – Head QA
- Distribution:
The original copies of the SOP’s of all the departments will be kept with Quality Assurance department and marked as “MASTER COPY” using a rubber stamp in Blue ink on top of right side corner of each page.
The photocopy of master SOP shall be issued to concern department after receiving SOP issuance request (having all the details like: Requisition For SOP Issuance, To:, From, Date of requisition, Sr. No., Name of SOP, Version Number, No. of copies required, Reason for request, Requested by:, Sign & date, HOD: Sign & date and Received by: Sign & date) and SOP will be marked as “CONTROLLED COPY” – using a rubber stamp in Blue ink on centre of the bottom of page with copy number.
All SOP’s will be issued by the Quality Assurance department against SOP issuance record which will have the following details:
SOP Issuance Records:, Name of the SOP, Annexure No., Revision No., Copy No., Date of issuance, Issued to Department, Issued by & date, Received by & date, Returned by & date, and Destructed by & date.
- Document control:
Quality Assurance will maintain the original copies of all the SOP’s used in the individual department with index page at the beginning of the file. These copies will be marked as “MASTER COPY”.
Each department will have a photocopy of their respective SOP’s required in their department. These will be marked as “CONTROLLED COPY”.
Individual departments / Sections will have a copy of all the SOP’s relevant to their section for displaying or filed appropriately and easily accessible.
If any of the departments require need to make any changes in the SOP concerning their department, then the concerned department should fill change control stating the reasons for change and hand it over to the Quality Assurance department for assessment and approval for proposed changes.
Quality Assurance department will review the changes and if found necessary will approve the change control and intimate concern department to proceed further.
- Issue of fresh SOP If the same are soiled /torn/lost:
If any SOP is soiled or torn/lost at the user end and the user needs a fresh copy of the SOP then the user has to submit a written requisition stating the Name and Number of the SOP and giving reasons why the SOP is to be reissued. This requisition should be authorised by the respective department head.
The torn or soiled/ lost SOP’s should be send along with requisition.
The Quality Assurance department will verify if the SOP needs to be re-issued if it is soiled or torn/lost. Then only the new SOP will be issued against the requisition for SOP and marked as a “RE-ISSUE’’.
The requisition from the concerned department will be attached to this SOP issuance records as a justification for the reissue.
- Issue of SOP’s to legal authorities & auditors:
Copy of SOP will be issued to FDA Inspectors or Auditors if request is made for the same.
This SOP will be marked as an “UNCONTROLLED COPY” in green ink and will be issued against the DISTRIBUTION LIST having all the details like: Distribution List, Sr. No., Name of the person, Date of issue, reason of issue, Issued by & Date and Remark.
- Destruction of supersedes / obsolete SOP:
Quality Assurance Department will maintain all superseding/obsolete documents and file them in a separate file “OBSOLETE FILE” after marked as an “OBSOLETE” in RED ink on the front side.
Concern Person will have to return all superseded SOP to the Quality Assurance department. After receipt of old documents the revised documents will be issued to them.
All superseded SOP’s of every department must be destroyed by tearing thorough shredding machine or manual tearing into smaller pieces by the Quality Assurance department.
Controlled copy to be destroyed immediately.
Obsolete Master copy to be scan in computer system and DVD.
After scanning obsolete Master copy to be destroyed.
Only last obsolete Master copy shall be kept as a hard copy.
Before the effective date of SOP all related concern person’s training will be completed.
- Abbreviation:
SOP : Standard Operating Procedure
QA : Quality Assurance
QAP : Quality Assurance Procedure
QA : Quality Assurance Department
QC : Quality Control Department
PD : Production Department
EG : Engineering Department
WH : Warehouse Department
HR : Human Resource Department
PA : Purchase and Accounts Department
FDA : Food and Drugs Administration
F : Format
R : Revision
No. : Number
DVD : Digital Video Disc
e.g. : Exempli gratia
*Note – Ready to use SOP available in “DOWNLOAD” Section.