SOP ON SOP
SOP ON SOP
PURPOSE
To lay down a standard procedure for the preparation, approval, authorization and control of Standard Operating Procedures.
SCOPE
This Standard Operating Procedure is applicable for the preparation, approval, control and implementation of all Standard Operating Procedures of all departments and it is to be followed
All the SOP that will be prepared after the effective date of this SOP will be as per the current Sop on SOP. The previously made SOPs will remain the same & will be changed department wise on campaign basis or at the time of the next review.
REFERENCE(S) & ATTACHMENT(S)
REFERENCE(S)
WHO_VSQ_97.01.pdf.
Schedule M.
CROSS REFERENCE DOCUMENTS
Document(s) and Data Control Procedure
Training Program and management.
Change Control Management
Good Document Practice (GDP)
ATTACHMENTS
ATTACHMENT
Template for SOP- Attachment-I
Template for Attachment – Attachment-II
Template for master list of SOPs – Attachment-III
Flow chart of new SOP preparation-Attachment-IV
Flow chart of SOP Revision-Attachment-V
LABEL
Template for Label – Attachment-VI
DEFINITION & ABBREVIATION(S)
DEFINITIONS
Standard Operating Procedure (SOP) is a prepared by authorized procedure which give a set of instruction for a routine or repetitive activity followed by an organization. it provide operating instruction to individual to perform a respective job properly, and facilitates consistency in the quality and integrity of a product or end result.
Good Manufacturing Practices: is a system for ensuring that products are consistently produced and controlled according to quality standards.
Current Good Manufacturing Practices (cGMPs): cGMP provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the cGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations.
Master Copy: An original document from which copies can be made for controlled and uncontrolled copy.
Controlled Copy: A controlled copy is a formal copy of the latest, correct issue (approved version) of document; an identified issue of a document to an individual or location of record. A controlled copy must be retrieval.
GxPs: The “x” in GxP is a variable that stands for manufacturing, clinical, laboratory, or clinical laboratory, Engineering, Warehouse etc. GxP generally refers to GMP, GDP, GLP, and GCP regulations and guidelines established by the U.S. Food and Drug Administration (FDA).
ABBREVIATIONS
SOPs: Standard Operating Procedures
EHS: Environment, Health and Safety
CQA: Corporate quality assurance
RESPONSIBILITY:
Staff & Above of Initiator Department shall be responsible for:
Development or generation of draft of new SOP as per the procedure given in this SOP.
Updation / Revision of the existing SOP, whenever required.
Head or his / her designee of Initiator department shall be responsible for:
Reviewing and checking of SOP.
Training of the user staff.
QA personnel shall be responsible for:
Checking, reviewing and formatting word processing styles for SOPs (if applicable) and allocate a unique number for new SOP.
Head/In charge Quality Assurance or his/her designee shall be responsible for:
Review and Authorizing of SOP for its correctness and adequacy with respect to regulations/ guidelines or company standards related to prepared by procedures, if applicable.
Final approval and subsequently compliance of the SOP.
PROCEDURE:
SAFETY/PRECAUTION/EHS
SOP shall be prepared by in short, clear sentences. SOP should be easy to understand / follow and shall depict the sequence of activities logically.
Competent staff shall prepare SOP as per Attachment-I (Template for Standard Operating Procedure).
SOP shall be prepared by after thorough understanding of the operating procedures. The initiator of the SOP shall have adequate knowledge, training and experience in the related areas of operation. Wherever necessary, some illustrations, drawings, flow charts may be incorporated in the SOP, to provide better clarity and understanding.
Wherever abbreviations are used, these shall be elaborated in point no. 4.2 “Abbreviations”.
Language of SOP
The English language/local language used in SOP shall be clear, instructive, sequential, and unambiguous
Initiation of a New SOP
For a new SOP, concerned department personnel shall prepare the draft of SOP using Attachment-I (Format for Standard Operating Procedure) with “DRAFT” watermark:
After completion of drafting of the SOP, the user shall send it to his/her Department Head for review.
Department Head shall review the draft SOP, put the remarks or suggestion if any and forward it to QA Deptt.
QA shall circulate the draft copy of SOP to the other concern interlink departments for review (if required).
After receiving the comment from other concern interlink departments (where applicable), QA personnel shall review the draft copy of the SOP, write the comment (if any).
After QA comment on the draft copy of the SOP, QA personnel send it to QA Head for comments, if any.
QA Head or his/her designee shall review the draft copy of SOP and put the comments, if any, and finally QA Head or his/her designee shall approve the draft copy of SOP by makings his initial.
After approval of the draft, it shall be forwarded to initiator department. The initiator department personnel incorporates all comments and necessary corrections, if any, as per approved draft SOP and takes the final print in black ink on A4 size white paper (on one side of the paper only).
The SOP shall be finally signed by all concerned personnel as mentioned below in the point.
In case of the rejection of draft copy of SOP by QA Head or his/her designee, the same shall be maintained by QA personnel.
SOP numbering system
SOP number shall consist of 13 alphanumeric characters i.e. “LC/YYY-NNN/ZZ”.
LC : for location code that is AA
‘/’ : Forward slash
YYY: Department code (Refer Document and data control SOP).
‘-’ : ‘dash’
NNN: Serial no. of SOP in a department like 001, 002, etc.
‘/’ : Forward slash
ZZ : Version no. of SOP. The first version of SOP is 00. Subsequent revisions will be 01. For example, the first SOP prepared by for Quality Assurance shall be numbered as AA/QAD-001/00.
Formatting of SOP
All SOPs shall have a standard common format for page layout as per Attachment-I. SOP margins setting for portrait size/landscape size 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.
Portrait and landscape size- 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 ribbon tab.
Portrait size- 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.
Landscape size- Footer size table will contain two row first row contain particulars persons from dedicated department and size will be 0.3. Second row space will be used for signature purpose and size will be 0.8 And columns width size shall be 2.25, for size setting; double click on footer and select the table now you will choose the layout caption from Microsoft word ribbon tab 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 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 1.5 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.
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.
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.
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. Example: If SOP No. QAD-002/01 is revised and QAD-002/02 is the new SOP No. Then QAD-002/01 shall appear in the column of supersedes.
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 2024 then next review date shall be mentioned as “31 DEC 2026”.
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
Attachments as third sub-point; it shall enlist all attachment, all labels, flow charts or any other attachment with the SOP. Attachment will be use same as with SOP attached. there is not allowed to edit or modification in attachment while using for routine issuance purpose.
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 1 and sub-section 2.
Sub-section 1 shall describe the Safety/Precaution or EHS measure shall be prepared by as per requirement of SOP and 2 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.
Note: All digital signature coordinates approx. value given below table for landscape/portrait size. But Coordinates may differ from given below coordinates it will be depend on setting of pages, header, footer and Microsoft word version No. and may other setting. All signatures shall be made as per Document and data control SOP No. (digitally/manually).
Training
Once the concerned SOP is approved by QA head or his/her designee and Plant head, initiator department shall conduct training of the SOP and evaluation of training there upon.
Note: If a department prepares an SOP that involves other interlink departments(s) in its execution, and then the persons from other concern department(s) shall also be trained.
Department Head shall ensure that training is imparted to all concerned.
After completion of training on concerned approved SOP, the initiator department shall forward training record Photocopy to QA for change control reference.
QA personnel shall retain the training record with change control and put the effective date and review date in approved SOP.
Master Copies and Controlled Copies (for distribution), Uncontrolled copies (for reference copy) of the SOPs shall be prepared by QA as described in SOP on ‘Document and Data Control’
Issuance, distribution and retrieval of control and uncontrolled copy of SOP shall be done as per SOP ‘Document and Data Control’
Training questioner shall be issue without control copy by user department.
Revision of SOP
All SOP shall be reviewed as per SOP on ‘Document and Data Control’
Storage, archival, obsoletion & superseded of SOPs.
Storage, archival, obsoletion and superseded of SOPs shall be done by QA as per SOP ‘Document and Data Control’
Master List of SOPs
Concerned department shall Prepared the master list of SOPs as per Attachment-III. It shall contain the list of SOP’s of all the departments.
Master list of SOPs shall be approved by QA Head /designee.
The list shall be revised as and when required.
A hard copy of Master List of SOP shall be printed by concerned department and signed off then submit to QA officer or above for signing off and finally approved by QA Head / designee and kept in QA records as master copy.
Numbering system of Master List: Each Master list shall be allocate unique Master list numbering e.g. “ML/NNN/DC/YY/RR”.
ML: indicate Master List of Standard operating procedure (SOPs)
NNN: indicate for subject code such as SOP, Approved Vendor List (AVL), and Process Performance Qualification (PPQ); etc. ML/SOP/QAD/20/00, ML/AVL/QAD/20/00 etc.
DC: indicate for departmental code ML/QAD/23/00
YY: indicate two digit current calendar year e.g.2023 shall be represent as 23.
RR: indicate two revision numbers starting from 00.
Content of format
A format for recording/execution of data/information related to procedure mentioned in the SOP shall be prepared as per attachment-III during SOPs preparation and all recording formats shall be attached with SOP as attachments. The numbering of the attachment should be given in roman numerals as I, II and so on.
A list of attachment(s), described in the SOP, shall be mentioned (along with attachment number and name and format No.).
The format shall be prepared by in Arial font size 11 or as per requirement.
The format number shall be write below the footer on the left side or as per space availability in document.
Page no. shall be write at the header of the page at right side in formats.
Format used for technical directions/guidance to perform any activity like picture, drawing, list, flow chart etc. related to SOP and not used for recording/execution of data/information, may be attached with SOP in form of attachment.
Signature with date columns for format is also same as SOP and stamping shall be made in all attachments.
Format number of SOPs shall consist of 17 alphanumeric characters. A unique format number shall be allocate to the format as described below:
The first Ten characters of the form number shall be derived from the concerned SOP and the remaining seven characters shall be as follows
The eleventh character shall be a ‘/’ (forward slash).
The twelfth character shall always be ‘F’ which denotes ‘Format’.
The thirteenth & fourteenth characters shall denote the Format’s Serial Number ranging from 01, 02, so on.
The fifteenth character shall be a ‘/’ (forward slash).
The sixteenth and seventeenth characters shall denote the Revision Number of the form. The first version of any format shall carry Revision Number ‘00’. The subsequent revisions shall have Revision Number 01, 02, so on.
Example: Format number QAD-001/F02/00 is the first version of the second format of first SOP of Quality Assurance.
Note- Where format used for electronically, in such case all the content of electronic generated format shall be same as mention in format and it may be Microsoft word, excel, and power point or any other electronic format. Such electronic format shall be contain only format No. and no need to stamp master copy and controlled copy in this electronically generated data.
Digital signature procedure
Firstly double click to PDF signer register version software then a PDF signer interface will be open.
And choose digitally sign on- single PDF document or a folder with PDF document. If sign want to apply on single file you will choose first option. If signature want to apply on multiple file then choose to second option a folder with PDF document. We can choose one at one from both of them depending on your requirement.
After choose document then select the source of file by click on triple dot which is given below source heading in software interface. For selection file just click and select the file from PC and click on OK. File automatically upload for digitally signature software.
After that select the destination for signed file where you want to file save. If you want create a folder on desktop with Signed Document name. Select the destination pathway by click the triple dots and select the signed document folder. The signed document will found here after signature. And if you don’t select the destination of file then file will be found on same destination where you file will upload for signing.
After select the destination you will select the Digital signature certificate. This setting you will see the right side corner of the PDF signer software interface. Single click on select the Digital certificate a small interface of digital certificate will open then you select digital signature certificate by click on no certificate selected in fifth line.
Now you will insert your provided DSC (pen drive) in to your system and select your name in list and click on after click name will select automatically then select ok after selection DSC select will automatically.
After that signature appearance will be select for next step. When you click on signature appearance see in right side above the bottom. Signature appearance interface will open. Firstly click on box which is nearly signature pages and select the one as per requirement.
- First pages –if you want sign only first pages
- Last pages- if you want sign last pages
- All pages – if you want sign on all pages
After select the custom position which is given below the signature page for select position of signature. There is four coordinates i.e. X-axis, Y-axis, Height and width. This coordinates is as per table No-1 use for different position. Insert the coordinates as per requirement.
Then select the font size 8 given middle upper side by click on font size and simply select the size 8.
Then select the standard fonts which given below the font size by click on box a list will be open and select the Times-Roman font.
Then personalize the signature appearance by using the right side interface setting i.e. configuration signature box. Simply select or tick below list-
- Name from digitally certificate
- Location
- Signing date
- Label- after select label there is small interface of label which have four option as below written
- Signed by
- Location
- Reason
- Signing date
Signed by box write here – TYPE YOUR NAME (in capital letters) after give 5-6 time space and after type- Digitally Signed by (in small letters) type this information in to Signed by box for your digitally name display in signature box.
E.g. RAM KUMAR Digitally Signed by
After that write location in this box write your department name in small letters.e.g. QA.Deparment
All other remaining information leave it blank don’t fill anything in to the box.
- After fill all those necessary entries in to configuration signature box click on Ok which is given below right corner all information save automatically for signature appearance.
- Then click on apply digital signature after click on a small interface will open you type your password and click on login box.
- Digital signature will apply automatically on selected file. File will save where you choose the destination of saver file.
- Open the signature file and verified that digital signature apply successfully.
- If signature position found not correct place then you have to change coordinates again as minor ± value and follow the same above written procedure till get required correct position.
- After found correct position of digital signature save the file and forward to next further step as per procedure.
REVISION HISTORY:
New SOP Prepared.
