Preparation of SOP of SOP

1.0 Objective:
1.1 To define the method by which new or revised Standard Operating Procedure (SOPs) shall be written,

reviewed, approved, distributed, retrieved, implemented and maintained.
2.0 Scope:
2.1 To provide form, format and guidelines to those who participate in the preparation and implementation
of SOPs at Abc Pvt. Ltd.
3.0 Responsibilities
3.1 User department managers r designee are responsible to ensure that all SOPs for their departments

are prepared, implemented and maintained in accordance with the requirements of this document.
3.2 Officer or designee of User department is responsible for preparing or revising the SOP as per the

actual work he/she performs.
3.3 The officer or designee of User department is responsible for review of the new/revised SOP for the

compliance t GMP requirements.
3.4 The manager or designee of User department I responsible for review of new/revised SOP for technical

applications and approval.
3.5 The manage QA or designee of is responsible for review of new/revised SOP for the compliance with the

Quality System Policy of Abc Pvt. Ltd. of the final SOP.
3.6 QA is responsible for generation, distribution of new/revised SOPs and retrieve superseded

version of the distributed SOP when a new/revised SOP is issued or when an SOP is made obsolete.
3.7 QA officer or designee to maintain the SOP Distribution sheet, Additional Copy Requisition/Return

Forms and Master SOP Index.
3.8 Managers or designe of User department shall responsible for giving the training

on new/revised SOP and maintain the related records.
4.0 Documents and Formats:
4.1 Master SOP document and formats number
5.0 Materials, Equipment and Definitions:
5.1 Material:
5.1.1 Copy of SOP being revised
5.1.2 A4 size AbcPvt. Ltd. Name on paper
5.1.3 Blue ink ball point pen
5.1.4 Master copy stamp
5.1.5 Red ink pad and Blue ink pad
5.1.6 Controlled copy stamp
5.1.7 Display copy stamp
5.2 Equipment’s:
5.2.1 Computer and printer
5.2.2 Photocopier machine
5.3 Definitions:
5.3.1 User Document: The department who owns and uses the area, equipment, process and methods

for the various GMP operations which required to be guided with Standard Operating Procedures

for assuring the consistency and uniformity of activities.
5.3.2 Official Copies: Photocopies of master SOP, to be distributed to user departments

(for example controlled copy and display copy) with the original sign of QA Documentation Cell personnel.
5.3.3 Effective Date: The date from which new prepared/revised SOP shall be implemented.
5.3.4 Review Date: The date on or before that current SOP is revised and made obsolete and

new revised version of same SOP made effective.
6.0 Procedure:
6.1 General Information:
6.1.1 Prepare the draft copy of the new/or revised SOP and distribute for preliminary review and

comment to the next level responsible personal of the department.
6.1.2 Conduct the training within 14 days after the authorization of SOP and maintain the training record.
6.1.3 Convert the SOP in the revised format (e.g. header, section headings, footer etc.)
6.1.4 Follow the DCR procedure in case SOP is being revised.
NOTE: DCR Procedure is not required in case, SOP is being revised on periodic review and only

minor changes are requested which do not affect directly or indirectly to the product quality,

any other document and any procedure etc.
In this case next version shall be given to the SOP and revision history shall be maintained for changes done.
6.1.5 If requesting changes to, or absolution of, an SOP that does not belong to your discuss the

requested changes with the department manager or supervisor of the effected department.
6.1.5.1 Example: when a member of production Department wants to submit changes for a

QC SOP, then person shall discuss the changes with QC Manager. That manager may

agree or disagree with the proposed changes.
6.1.5.2 If the changes are agreed upon, continue as outlined as per this SOP.
6.1.5.3 If the changes re not agreed upon, nothing also needs to be done as the changes shall not be made.
6.1.6 Effective date & review date of SOP shall be written in following fashion e.g.
Effective date: 03/01/2025, then Review date will be 02/01/2027.
6.2 Content of SOP:
6.2.1 SOP shall be prepared with following fixed contents:
Section 1.0 Objective
Section 2.0 Scope
Section 3.0 Responsibility
Section 4.0 Abbreviations and Definitions
Section 5.0 Procedure (Include documentation)
Section 6.0 Forms and Records
Section 7.0 Distribution
Section 8.0 SOP revision history
6.2.2 Any Section that does not apply shall have NA or N/A listed for that section.
6.3 Formatting System of SOP:
6.3.1 As the need arises the user department shall prepare o revise an SOP using the

guideline as indicated in this SOP
6.3.2 Format the SOPs using MS Word for Windows system.
6.3.3 Follow the standard parameterfor formatting the SOP as given below:

Paper Size	A4 Size
Paper Color	White
Top Margins	0.75”
Bottom Margins	0.75”
Left Margins	0.65”
Right Margins	0.75”
Alignment	Justify
Gutter	0”
Header from edge	1.5”
Footer from edge	1.5”
Line space (before/after) main points	Single (6 pt / 6 pt)
Line space (before / after) sub points	Single (3 pt / 3 pt)
Line space (before / after) sub-sub points	Single (0 pt / 0 pt)
Section Numbering	1.0, 2.0…
Line Numbering	1.1, 1.2…
Page Numbering	X of Y Format
Number Position	Left, Tab space after-0.5”, Indent at-0.5”
Indentation	Left-0.5”, Right-0.0”,Special-Hanging, By-0.5”
Language	English
Translation language (if applicable)	Hindi
Grammar	Active/Present
AbcPvt. Ltd.	Times New Roman, Bold/ 18pt
Barivas Biotech Pvt. Ltd. (Logo)	Times New Roman, Bold/ 8pt
Font Type, Size (Header)	Times New Roman, Bold/ 12pt
Font Type, Size (Footer)	Times New Roman, Bold/ 12pt
Font Size (Sections)	Times New Roman, Bold/ 11pt
Font Type, Size (Text)	Times New Roman, Bold/ 11pt
Font Type / Font size (Title of Forms)	Times New Roman, Bold/ 11pt
Font Type / Font size (Content of Forms)	Times New Roman, plain / ≤11 pt.
Printing (one side or two sides)	One side

6.3.4 Title of the SOP shall be described in brief and same title shall not be repeated for any other SOPs.
6.3.5 Each page of SOP shall contain page number.
6.3.6 Begin each SOP with a statement of its purpose and scope. (Section 1.0).
6.3.7 State clearly by job title who is responsible for performing the activity required by the SOP. (Section 2.0). The word “or designee” shall be included (if required) to avoid undue limitations upon personnel for performing an activity in his absence.
6.3.8 List all documents and forms required to perform the procedure (Section 3.0).
6.3.8.1 If forms are listed under (Section 3.0 Documents and Forms), a copy of the form shall be included in the SOP.
6.3.9 List all material o equipment needed to perform the procedure and any definitions of words or phrases that may be confusing (Section 4.0).
6.3.9.1 Allow for the use of alternate items, unless doing so would compromise the performance or outcome of the process.
6.3.10 Describe the procedure or steps used to perform the duties as described in the SOP (Section 5.0).
6.3.10.1 When Notes or Warnings are required, they should be in bold type and place at the beginning of the step to which they refer.
6.3.10.2 Use one sentence and section number for each action step.
6.3.10.3 Numbered or bulleted list or table may be used within sub-sections as appropriate.
6.3.10.4 State each step as clearly as possible.
6.3.11 SOPs shall have the following information in the header:
6.3.11.1 Name of organization with location
6.3.11.2 SOP Number
6.3.11.3 Standard Operation Procedure to be stated below the box of name of organization
6.3.11.4 Revision Number
6.3.11.5 Department
6.3.11.6 Effective date
6.3.11.7 Superseded SOP Number with revision number
6.3.11.8 Title
6.3.11.9 Review Date
6.3.11.10 Page Number

6.3.12 SOPs shall have the following information in the approval list:
6.3.12.1 Name
6.3.12.2 Signature
6.3.12.3 Date
6.3.12.4 Prepared By
6.3.12.5 Reviewed By
6.3.12.6 Approved By

Approval List
	Prepared by	Reviewed by	Authorized by
Signature
Date
Department	Quality Assurance	Quality Assurance	Quality Assurance

6.3.13 SOPs shall have the following information in the distribution list:
6.3.13.1 Department
6.3.13.2 No. of Controlled Copy Required
6.3.13.3 No. of Display Copy Required
6.3.13.4 Total Number of the copies to be issued

Distribution List
Department	No. of Controlled Copy Required	No. of Display Copy Required	Total No. of Copies to be Issued
Personnel and Administration
Production
Engineering
Quality Assurance
Quality Control
Warehouse

6.4 Numbering System of SOP:
6.4.1 Follow the SOP Numbering System: A/B/C/D where,
6.4.1.1 A is Organization code- Abc Pvt. Ltd. (BBL).
6.4.1.2 B is Department code as given in below table
6.4.1.3 C standsfor SOP
6.4.1.4 D is the serial number of SOP starting from 001, 002…. and so on.
6.4.1.5 For example ABCL/QA/SOP/001
Department Code

Department	Code
Personnel and Administration	P&A
Production	PR
Engineering	EG
Quality Assurance	QA
Quality Control	QC
Warehouse	WH

6.5 Format Numbering System:
6.5.1 Follow the numbering System: A/B/C where,
6.5.1.1 A Stands for department code & SOP Numbers.
6.5.1.2 B Stands for Format number.
6.5.1.3 C Stands for revision number.
6.6 Superseded SOP Numbering system:
6.6.1 Follow the numbering System: A/B/C/D/E where,
6.6.1.1 A Stands for company Name Abc Pvt. Ltd. (BBL)
6.6.1.2 B Stands for department code
6.6.1.3 C Stands for SOP
6.6.1.4 D Stands for serial number of SOP
6.6.1.5 F Stands for the revision number of SOP starting

from 00,01,02……..and so on Example:
6.7 Review and Approval of SOP:
6.7.1 Executive or designee of initiating department who has prepared the SOP take

the print out of the draft SOP and shall submit the proposed SOP o his dept. head or

designee for review. After reviewing He/She shall make correction if any and shall take

final print on logo paper and sign in Prepared By space and shall handover the SOP to his

senior (Preferably HOD) for signature in Reviewed By space of SOP.
6.7.2 For QA approval, carry out following steps:
6.7.2.1 Filled DCR form, preferably along with rough copy of previous revision wherein

correction are made (if any SOP is being modified)
6.7.2.2 Head QA shall review the SOP, if any correction is required during this review, Head QA

shall send back documents to respective department for corrections. This department, in turn,

shall make corrections and forward corrected document to Head QA.
6.7.2.3 Head QA shall review the same and if found satisfactory, sign in authorized by

space in the SOP and give these all documents to initiating department for training purp.
6.8 Training:
6.8.1 After approval by Manager QA training shall be conducted for the SOP.
6.8.2 Initiating department shall organize and conduct the training of the SOP

within 14 calendar days after authorization date of SOP.
6.8.3 Initiating department shall send back the SOP along with copy of training

attendance sheet to QA department for master and custody.
6.8.4 Training shall be conducted in each affected department or departments.
6.8.5 SOPs shall be issued an effective date by QA document cell after completion of training.
6.9 Distribution of the SOP:
6.9.1 After completion of training and receiving SOP from initiating department, QA officer

or designee shall stamp “Master Copy” on each page of the SOP with hand written effective date and review date.
6.9.2 After stamping master copy, effective date and review date, QA officer shall distribute

SOP only to areas those relate directly to the job function (as per distribution list). Master copies

of all SOP’s shall be stored with QA document cell. QA document cell officer shall issue official copies t concern department.
6.9.3 Official copy shall be made by taking photocopy of Master copy.
6.9.4 Stamping and numbering of control and display copy of SOP shall be done through SOP No.
6.10 Implementation:
6.10.1 Implementation of SOP shall be as follows:
6.10.1.1 Upon receipt of the effective SOP, the supervisor designee shall replace SOPs, acknowledge

the receipt in respective form, and return the control and display copy of superseded version of SOP to the QA officer.
6.10.1.2 QA document cell officer destroy all official superseded SOP’s as per the SOP No. BBL/QA/SOP/001 by shredding.
6.10.1.3 If an official copy of an SOP is no longer needed or additional copy required, concern

department manager or designee shall fill up the request form additional copy Requisition/return

format no. and submit to QA document cell for QA approval.
6.10.1.4 When the SOP is issued an effective date, the QA officer shall update the soft

copy of Master SOP Index (as per Format No.
6.10.1.5 Review Period: At a minimum, SOP review shall be done within 24 months.
6.10.1.6 If any changes required in between due to pharmacopoeial changes or changes

need to meet regulatory requirements/Audits, SOP shall be revised as and when required

and shall be routed through DCR procedure.
6.10.1.7 The QA officer shall print the Master SOP Index on 3 months basis or whenever is needed.

This copy shall become the official copy of the index. Any subsequent copies shall over-ride

the existing copies, which shall be destroyed. The printed Index shall be stored in a locked cabinet with QA.
7.0 Acceptance Criteria:
7.1 Prepare, maintain ad revise the SOPs as per the Standard Parameters mentioned in the SOP.
8.0 References:
8.1 In House
9.0 Abbreviations:

abc	Abc Pvt. Ltd.
GMP	Good Manufacturing Practice
PR	Production
QA	Quality Assurance
QC	Quality Control
SOP	Standard Operating Procedure
NA	Not Applicable
DCR	Document Change Request
CCR	Change Control Request