1.0
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PURPOSE
To lay down a procedure for the preparation, approval, authorization, control and revision of Standard Operating Procedures.
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2.0
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SCOPE
This SOP shall be applicable to all the SOPs at “Company Name” & company Address.
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3.0
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RESPONSIBILITY
Officer & Executive and above of the concerned Department shall be responsible for preparation and execution of the SOP.
Head of QA Department shall be responsible for the approval of the SOP.
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4.0
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ACCOUNTABILITY
All concerned section heads are accountable for the implementation of SOP for SOP.
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5.0
5.1
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PROCEDURE
For Writing SOP’s All Departments Shall Follow Following Guideline
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5.1.1
5.1.2
5.1.3
5.1.4
5.1.5
5.1.6
5.2
5.3
5.3.1
5.3.2
5.3.3
5.4
5.4.1
5.4.2
5.4.3
5.4.3.1
5.4.3.2
5.4.3.3
5.4.4
5.4.5
5.4.6
5.4.7
5.4.8
5.4.9
5.4.10
5.4.11
5.4.12
5.4.13
5.4.14
5.5
5.5.1
5.5.2
5.5.3
5.5.4
5.5.5
5.5.6
5.5.7
5.5.8
5.6
5.7
5.8
5.8.1
5.8.2
5.8.3
5.9
5.10
5.10.1
5.10.2
5.11
5.11.1
5.11.2
5.11.3
5.11.4
5.11.5
5.9.8
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The SOP shall be written in English Language.
Incase the Users are not able to read or understand English, The SOP shall be written in Local script of Language.
The procedure shall cover all activities of Operation in order and area of application mentioned in SCOPE.
The related Diagrams, Flow Charts, Pictures (where ever it helps to understand procedure better) and reference to other related SOP or documents shall be made part of the SOP to clear the procedure of SOP.
SOP shall be written in un ambiguous statement.
The procedure of SOP shall have the reference of related document such as Current Good Manufacturing Procedure, Manuals, Pharmacopoeia, and Guidelines given by various Regulatory Authorities.
Each SOP will be prepared on a A4 Size page, white paper background in Portrait form with-
Page Margin: Normal Top: 1cm Bottom: 1 cm
Left: 1cm Right: 1cm
All SOPs shall be in font “Times New Roman” and having a single line border of page.
General Feature of SOP:
SOP divided into three parts:
Header
Body
Footer
Header of SOP Contains:
Header shall be in tabular form. In first row left side top corner Logo of the firm with Font size-14 Bold
Name of Firm [Font Times New Roman, Font size-14 Bold], address [ Font Times New Roman, Font size-12 Unbold ] of the firm and both centralized, Title- STANDARD OPERATING PROCEDURE [Font Times New Roman, Font size-14 Bold ],centralized and whole remaining text of Header having [ Font Times New Roman, Font size-12 Unbold, All Heading-Bold] format as follows:
Department
This contains name of the originating /user department specifying the area or section where the SOP shall be applicable.
Subject
It contains detailed heading of the SOP
SOP No.
Each SOP except production Deptt. Shall be given a unique number. The numbering system of the SOP shall be of “Fourteen” digits - Eight alphabets, Three numeric and Three separators.
For Example the SOP of QA department shall be numbered as XXX/SOP/QA/000
· First three characters ‘Company nameXXX’ indicate the name of the company.
· 4th character ‘/ ’ is separator
· 5th, 6th and 7th character ‘SOP’ indicate Standard operating Procedure
· 8th character ‘/ ’ is separator
· 9th and 10th character ‘QA’ indicate the name of department
· 11th character ‘/ ’ is separator
· Last three numeric digits ‘000’ indicate SOP No.
Production Deptt. SOP shall be given a unique number. The numbering system of the SOP shall be of “Sixteen” digits - Nine alphabets, Three numeric and Four separators.
For Example the SOP of Tablet department shall be numbered as XXX/SOP/PR/T-000
· First three characters ‘XXX’ indicate the name of the company.
· 4th character ‘/ ’ is separator
· 5th, 6th and 7th character ‘SOP’ indicate Standard operating Procedure
· 8th character ‘/ ’ is separator
· 9th and 10th character ‘PR’ indicate the name of department
· 11th character ‘/ ’ is separator
· 12 th character for concern Section
· 13th character ‘-‘is seprater
· Last three numeric digits ‘000’ indicate SOP No.
Concern Production Deptt. shall define as per code
a)T- Tablet b) E-External
c)S-Soap d) L-Liquid
Similarly code for different Departments shall be define as:
Hence the first SOP for QA shall be numbered as XXX/SOP/QA/001, XXX/SOP/PR/X-001 for Production, XXX/SOP/QC/001 for QC and XXX/SOP/UT/001 for Engineering and XXX/SOP/ST/001 for Store. Where X define for various section of Production Deptt.
Issue Date
It is the date on which the SOP is issued to the concerned departments.
Revision No.
It denotes the number of revisions the SOP has undergone. For example R-00 denotes original SOP, R-01 denotes revised once and R-02 denotes revised twice and so on.
Effective Date
It is the date on which the SOP shall be implemented to the concerned departments, 4-5 days period between effective date and issue date in order to accommodate required training to implement the SOP.
For example if any SOP approved on 03/03/08, then Effective Date shall be 07/03/08
Review Date
Each SOP will be reviewed after 2 years. However any change in any procedure should require a review and re-issuance of the SOP as and when the change is implemented.
Page No.
This gives the running page number, followed by the total number of pages.
Prepared By
A designated person from originating/user Department who is responsible for writing the SOP. The person will sign and write his/her Name in blue ink (Bold Letters) with designation and date.
Checked By
The person who checks any SOP shall be from user department, the person will sign and write his/her Name in blue ink (Bold Letters) with designation and date and shall have thorough knowledge and understanding of the operation.
Approved By
Head of the Quality Assurance Department or designated person on his behalf from Quality Assurance shall be authorized to approve any SOP prepared on the format and guidelines prescribed here in.
Authorized By
All the SOPs shall be Authorized by the Technical Director of the plant.
Body Text of SOP Contains:
[Font Times New Roman, Font size-11Unbold and All Heading Bold& line spacing1]
Purpose
The content of the Standard Operating Procedures must include one `Purpose’ which is a brief description of why the procedure has written.
Responsibility
This includes the job titles of personnel in a given operation including those of other departments referred.
Accountability
It includes the accountability of the written procedure by the Technical personnel of the Dept.
Procedures
This describes briefly and clearly the actual way in which the operation is to be carried out or performed.
Reference
This describes the SOP is prepared from which guideline, manual or IHS.
Annexures
Any text, forms, formats or observation sheet which is complementary to the SOP should be enclosed. The Annexure contains its serial number (As Annexure- I, Annexure – II….etc.) and reference of the concern SOP No. For example an annexure to this SOP shall be Annexure-I Refer SOP No: XXX/SOP/QA/001.
Abbreviations
Full form of any abbreviation used.
Revision History
No change in any SOP is allowed by the users. Whenever any change is necessary in any document, the document shall be rewritten, duly checked, authorized and signed by two independent persons who are responsible for the SOP. A cross reference of the superseded SOP shall be made on the new SOP. For every
such change we will fill the “Change Control Form” along with date of change, reason for change and the revision no. The change will be designated as Major/Minor.
Footer of SOP Contains:
Unique 13 digit Format No. [Font Times New Roman, Font size-10Unbold] left side, used to prepare the SOPs.
For example: Format No. for format used for preparation of SOP shall be
· QA indicate: Quality Assurance
· ‘/’ indicate : Separator
· 001 indicate: Serial No. of SOP
· F01 indicate: Format
· ‘-’ indicate : Separator
· 00 indicate: Revision No.
Index Of SOP
Index of SOPs shall be maintained as per define below, which consist of header footer and body.
Header consist of following content as mention below
Body consist of following details:
For example: INDEX No. for Quality assurance used for preparation of SOP Index shall be
· QA indicate: Quality Assurance
· ‘/’ indicate : Separator
· IND indicate: index of SOP
· ‘-’ indicate : Separator
· 001 indicate: Revision No.
Similarly code for different Departments shall be define as:
Distribution of SOP
The SOP shall be distributed to respective department by QA and a Distribution list shall be maintained. The Head QA shall approved the distribution of SOP and shall sign for “Issued by”. The recipient of SOP shall sign as token of acceptance to implement.
The Revised SOP shall be distributed only after recall of superseded SOP.
Training
Training of SOP’s shall be given to concerned department and training of cross functional SOP’s shall be given to all departments.
Training date shall be between date of Authorization and Effective Date. Training of SOP shall be given to all concern departments before distribution. Each SOP training shall be recorded in Annexure-II [Refer to
SOP No. XXX/SOP/QA/002]
Issuance, Control And Revision
Original set of SOP duly Signed, Dated, Approved and Authorized, which shall be termed as Master Copy and shall be stamped as ‘MASTER DOCUMENT’[Green Colour] in center and maintained in the Quality Assurance Department as shown below:
Quality Assurance Department shall make photocopies of the master copy for the distribution to the concerned Departments, such photocopies shall be termed as Controlled Copy at right hand corner and shall be stamped as ‘CONTROLLED DOCUMENT’[Blue Colour] as shown below:
Quality Assurance Department shall make photocopies of the master copy for the display to the concerned Departments, such photocopies shall be termed as Display Copy at right hand corner and shall be stamped as ‘Display Copy’[Blue Colour] as shown below:
The Copy of SOP that is meant only for Information/Reference purpose shall be made by Photostat of Master Copy and shall be stamped as ‘UNCONTROLLED DOCUMENT’ in Blue ink as shown below:
Old or superseded controlled copies must be returned to QA Department. The QA Manager shall ensure reconciliation and destroy controlled copies received from the department concerned.
The superseded master copy shall be maintained in the record room and shall be stamped as ‘OBSOLETE DOCUMENT’[Red Colour] as shown below:
All Master copies of SOP’s shall be typed or printed in black ink and signed by Blue ink.
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6.0
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REFERENCES
Not Applicable
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7.0
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ANNEXURES
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Annexure No.
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Title of Annexure
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Format No.
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Nil
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8.0
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ABBREVIATIONS
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Abbreviations
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Full Forms
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SOP
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Standard Operating Procedure
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XXX
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Company Name
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No.
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Number
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QA
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Quality Assurance
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QC
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Quality Control
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PR
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Production
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EN
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Engineering
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ST
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Store
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HR
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Human Resource
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Sign
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Signature
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9.0 DISTRIBUTION
Master Copy
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Quality Assurance Department
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Controlled Office Copy No. 1
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Head Quality Assurance
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Controlled Office Copy No. 2
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Head Quality Control
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Controlled Office Copy No. 3
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Head Production (Tablet)
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Controlled Office Copy No. 4
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Head Production (Liquid)
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Controlled Office Copy No. 5
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Head Production (External)
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Controlled Office Copy No. 6
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Head Production (Soap)
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Controlled Office Copy No. 7
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Head Personnel & Administration
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Controlled Office Copy No. 8
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Head Warehouse ( Main)
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Controlled Office Copy No. 8
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Head Warehouse ( External)
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Controlled Office Copy No. 9
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Head Information and Technology
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Controlled Office Copy No. 10
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Head Engineering
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10.0
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REVISION HISTORY
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S.No.
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Revision No.
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Effective Date
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Reason for Revision
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Details of Change
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Authorized By
(sign & Date)
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