SOP Format
Standard Operating Procedure; a document where step by step instructions are cited to serve as support for methods or manners of fulfilling a function or functions reliably and consistently. A standard operating procedure is a set of instructions having the force of a directive, covering those features of operations that lend themselves to a definite or standardized procedure without loss of effectiveness. Standard Operating Policies and Procedures can be effective catalysts to drive performance improvement and improving organizational results. Every good quality system is based on its standard operating procedures (SOPs)
SOP Format for drafting SOPs
Formatting of SOP
All SOPs shall have a standard common format for page layout as per Annexure-I. SOP margins setting firstly you will open Microsoft word and select the page layouts setting in header bar and click the margins setting after click an interface of margins setting automatically open and choose Normal setting from list of standard margins for SOP preparation. The standard margins setting contain automatically size 1 from left, right, top and bottom side. If size automatically not select then you can use the custom setting option and add Size 1 manually.
Header space from top and footer space from bottom size will be 0.3. This size will be adding by Manually setting in Microsoft word firstly double click on header bar and a design setting open automatically and size of header and footer at right side of bar.
Footer size table will contain two row first row contain particulars persons from dedicated department and size will be 0.1. Second row space will be used for signature purpose and size will be 0.8 And columns width size shall be 1.5, for size setting; double click on footer and select the table now you will choose the layout caption from Microsoft word bar here you can see the distribution row setting. Now select or single click on target row and add size in distribution row height setting. Same procedure follow for columns width setting from distribution columns.
SOP On SOP – Initiation of new SOP In the Pharma Industry
SOP shall be neatly typed using Microsoft Word application software.
Page set up of word file for SOP preparation shall be as follows:
Orientation of page shall be portrait. Landscape orientation shall also be used in attachment (if required).
Paper size shall be A4 with width of 8.27 inch and height of 11.69 inch.
Line spacing between points shall be 5 before the new point and in case of headings, the line spacing shall be 1.5 before and after the heading.
All the points in the SOP shall be numbered sequentially. Similarly the sub-paragraphs of each point shall also be numbered sequentially, An outline system of numbering shall be followed as follows: first level shall be 1.0, 2.0, and 3.0 …….so on, second level shall be 1.1, 1.2, 1.3……..so on, this shall continue up to fourth level and fourth level shall be 1.1.1.1 and so on. This sequence shall be start from the heading of responsibility.
In case numbering of sub paragraph is not necessary and listing is essentials, bullets or other suitable identification marks may be used to illustrate the same.
SILDENAFIL CITRATE TABLETS
Contents of SOP
Contents of SOP shall be prepared by using “Arial” font size 11.
SOP content shall be divided into three parts:
- Header
- Body
- Footer
Contents of header
All pages of the SOP contain the header. Header shall start from the top and header divided in nine rows in first page and six row in continue from second page, in a first row of header attached the company Logo on the left side and write the name of the company on the middle side in bold letters by using “Arial” font size 14. And right side blank space left for digitally issuance.
In second row shall be mentioned “Standard Operating Procedure” with capital letters & bold letters by using “Arial” font size 11.
Third Row “Left Side Title of SOP” with capital letters & bold letters by using “Arial” font size 11 along with Right side “Page No” in X of Y format with sentence case by using “Arial” font size 11.
Fourth Row of header shall be mentioned “SOP No. with Current Revision No. followed by C.C No., Followed by Supersedes in middle right and on right side Effective Date” with sentence case by using “Arial” font size 11 in bold letter.
Fifth Row of header shall be mentioned SOP No. with revision no., followed by CC No., Supersedes (if any or write NIL if not) & followed by Effective Date by stamping in DD MMM YYYY format” with Capital by using “Arial” font size 11 in letter.
SOP ON SOP (Preparation, Approval, Review and Control of Standard Operating Procedures)
Description of header content is as follows:
Title: Subject of the SOP. It shall be prepared by with bold letters. The word “Title” shall be prepared by with capital letters.
Page No.: Mention page No. in this column. It shall be mentioned in “Page X of Y” format, X stands for page no. of the particular page and Y stands for total no. of pages of that SOP. Example: Second page of SOP with total 10 pages shall be numbered as “Page No. 2 of 10”.
SOP No.: SOP No. shall be allocates according the procedure mentioned in point number 6.4.
Change Control Number (CC No.): In case of new SOP or revision of SOP, mention CC no. allocated by QA department in Header column of change control No.
Supersedes: In case of new SOP, mention “Nil” in this column. In case of revision mention SOP No. of the superseded SOP along with previous version number.
Effective Date: ‘Effective Date’ is the date when the content of SOP becomes operational for the user department(s). It shall be stamped by QA department after completion of training on the approved SOP, in DD MMM YYYY format.
Next Review Date: Mention the next review date on which the SOP shall be reviewed. On first page of header in bold letter. It shall be mentioned in DD MMM YYYY format with blue ink stamp. All the SOP’s shall be reviewed every two year. Example: If effective date is 01 JAN 2023 then next review date shall be mentioned as “31 DEC 2024”.
Contents of body
The content of body of Standard Operating Procedure shall contain the following headings (all headings shall be prepared by with capital bold letters).
Purpose:
Purpose as first point; an overview of the intention of preparation of Standard Operating Procedure shall be briefly mentioned under this heading.
Scope:
Scope as second point; describes the site(s) / location(s) / plant(s) and/ or departments to which the Standard Operating Procedure is applicable.
Reference(s) & Attachment(s)
References:
References as Third point; includes details of any references used in order to design the system. The references can be an official publication, any published literature, guidelines, instruction manuals etc.
Cross reference documents:
This Section contain cross reference SOPs or inter-linked departmental SOPs or CQA SOP’s. Some SOPs are intimately linked to others. When information contained in more than one document is necessary to complete a task, it is useful to include a cross-reference section in each document.
Attachments/ Formats/ Annexure
Attachments as third sub-point; it shall enlist all specimen formats, specimen labels, flow charts or any other attachment with the SOP.
Definition & Abbreviation
Definition: Write down in this column wherever require the definitions of critical/ technical term related or used in SOP.
Abbreviations as fourth sub point; describes the meaning or explanation of term(s) which is (are) not common or having any specific meaning and expansion of abbreviation(s) used in the Standard Operating Procedure.
Responsibility:
Responsibility as fifth point; specifies designation of the personnel and name of department that shall be responsible for implementation and compliance of the Standard Operating Procedure.
Procedure: This section shall divide into sub-section 6.1 and sub-section 6.2.
Sub-section shall describe the Safety/Precaution or EHS measure shall be prepared by as per requirement of SOP and section describes the detailed procedure to be followed in simple and clear sentences. It may include the details of all operations, operational conditions and precautions to be taken, if any, etc.
If any coloured photograph is required for SOP then it can be incorporated in SOP
Revision History:
History of revision as seventh point; history shall contain a chronological record of significant changes/ modifications in an SOP in brief, mentioned in two row, first row contain four columns, namely: ‘Version Number’, followed by next column for write version no. followed by ‘Effective Date’, followed by next column for date in DD MMM YYYY format by stamping and below ‘Detail of Revision’.
In Revision history, only last two year history change shall be mention detailed and previous history shall be mention as Routine or periodic revision/Provisional or conditional revision as per changes made in previous version.
Contents of Footer
Prepared By: Signature with date of a concern department person who prepared SOP. Prepared by signature and date shall appear on each page of the SOP.
Checked By: Signature with date of a concern department person who checked SOP. Checked by signature with date and date shall appear on each page of the SOP.
Reviewed By: Signature with date of a QA person who reviewed SOP. Reviewed by signature and date shall appear on each page of the SOP.
Approved By: Signature with date of QA Head and Plant Head who has approved the SOP signature and date shall appear on each page of the SOP.
On each page footer Format Number shall mention as per respective format define in this SOP.
In case of Excel Sheet or label the format number shall be prepared by according to the space availability in the document.
| Annexure-I
Format for Standard Operating Procedure Department Name
Body of SOP
Form No.: SOP/QA-001/F01-00 |
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Annexure-II
Form No.: SOP/QA-001/F02-01 |
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Annexure – III Master List of SOPs
Name of Department: ______________
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