1. Responsibility
1.1. Preparation of SOPs
1.2. Checking of SOPs
1.3. Approval of SOPs
1.4. Control, Issuance, retrieval & distruction of SOPs
2. Accountability
2.1. Complinace of SOPs
3. Procedure
3.1. Format
3.2. Language
3.3. Classification
3.3.1. General SOPs (GN)
3.3.2. Sub-General SOPs (SG)
3.3.3. Specific SOPs (SP)
3.4. Numbering
3.4.1. Unique Alphanumeric number of 13 chracters, Ex: XX-YY-ZZZ-R01
3.4.1.1. XX - Originating Department
3.4.1.1.1. Quality Assurance - QA
3.4.1.1.2. Quality Control - QC
3.4.1.1.3. Production Oral - PO
3.4.1.1.4. Warehouse - WH
3.4.1.1.5. Engineering - ER
3.4.1.1.6. Personnel & Administration - PA
3.4.1.1.7. Regulatory Affairs - RA
3.4.1.2. YY - Category of SOP
3.4.1.3. ZZZ - Serial Number of SOP
3.4.1.4. R01 - version number of SOP
3.5. Creation of SOP
3.5.1. Computer generated A4 size one-sided
3.5.2. Font type and size (Arial 11)
3.5.3. Page Setup preferables
3.5.3.1. Top/Bottom/Left margins - 1 inch
3.5.3.2. Right margin - 0.7 inch
3.5.3.3. Gutter Header/Footer - 0.8/1.0 inch
3.5.3.4. Page border (from text) - top 4 points/bottom 0 points
3.5.3.5. Page border (from text) - left/right 12 points
3.5.3.6. Numbering Indent - 0 inch
3.5.3.7. Hanging indent/left tab - 0.75 inch
3.5.3.8. Line spacing - single
3.5.3.9. Heading/sub heading - Bold Letters
3.5.3.10. Paragraph spacing (before & after) - 6 points
3.5.4. Header
3.5.4.1. Name of the company
3.5.4.2. SOP
3.5.4.3. SOP number
3.5.4.4. Page numberings
3.5.4.5. Effective & Review date
3.5.4.6. Previous & next version
3.5.4.7. Originating Dept
3.5.4.8. Distribution list
3.5.5. Footer
3.5.5.1. Prepared By/Date
3.5.5.2. Checked By/Date
3.5.5.3. Approved By/Date
3.5.6. Body of SOP
4. List of Annexures
4.1. Number
4.2. Title
4.3. Format number
4.4. Total number of pages
5. Reason for Revision
5.1. Date of revision
5.2. Details of revision
6. Storage of SOPs
6.1. Hard and soft copies forwarded to QA Dept
6.2. Maintain current version for viewing
7. Master list of SOPs
7.1. Revised quarterly
7.2. QA maintains
8. Copies to regularatory agents/customers
8.1. Provided by QA only
8.2. Stamped as uncontrolled copy in Blue ink
9. Archival of SOP
9.1. Stamped as Obsolete copy in red ink
9.2. Deleted by QA from computer
9.3. Archived in QA records
9.4. Maintained for 10 years
10. Objective
10.1. Description of title
10.2. Intent of the SOP
11. Scope
11.1. Applicable areas/personnel/equipment/process
11.2. Not applicable areas/personnel/equipment/process
12. Flow Chart
13. References
13.1. Books
13.2. Operation Manuals
13.3. Guidelines
13.4. Statutary & Regulatory Requirements
13.5. SOPs made in the references
14. Abbreviation(s)/Acronym(s)
15. Training on SOPs
16. Master Copy of SOP
16.1. Stamped as Master Copy in Red Ink
16.2. Maintained & Controlled by QA
16.3. Filed department-wise
17. Distribution/issuance of controlled copies
17.1. Stamped as controlled copy & copy no in green ink
17.2. Numbered as per controlled copy reference
17.2.1. Quality Assurance - 1
17.2.2. Quality Control - 2
17.2.3. Production Oral - 3
17.2.4. Warehouse - 4
17.2.5. Engineering - 5
17.2.6. Personnel & Administration - 6
17.2.7. Regulatory Affairs - 7