SOP ON SOP

1.0	PURPOSE To lay down a procedure for the preparation, approval, authorization, control and revision of Standard Operating Procedures.
2.0	SCOPE This SOP shall be applicable to all the SOPs at “Company Name” & company Address.
3.0	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.
4.0	ACCOUNTABILITY All concerned section heads are accountable for the implementation of SOP for SOP.
5.0 5.1	PROCEDURE For Writing SOP’s All Departments Shall Follow Following Guideline
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	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: Company Logo Company name & address                                                                                         RESTRICTED CIRCULATION STANDARD OPERATING PROCEDURE Dept : Quality Assurance SOP No. Revision No. Subject: Procedure for writing , revision distribution &  control of standard Operating procedures Issue Date Effective Date Review Date Page 2of11 Prepared By Checked By Approved By Authorized By Signature Name Designation Date 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: Department Code Quality Assurance QA Quality Control QC Production PR Utility UT Store ST Human Resource HR 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 Format No.: QA/001/F01-00 ·     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 Company Logo Company Name & address                                                                                         RESTRICTED CIRCULATION MASTER SOP INDEX Dept : Index No. Supersedes No. Subject: Issue Date Effective Date Review Date Page Prepared By Checked By Approved By Authorized By Signature Name Designation Date    Body consist of following details: Sr. No. Title of SOP SOP No. Revision No.        Effective Date Format No.: QA/001/F01-00 Footer consist of Format no as define below- Format No.: QA/001/F01-00 For example: INDEX No. for Quality assurance used for preparation of SOP  Index shall be Format No.: QA/IND/001 ·     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: Department Code Quality Assurance QA Quality Control QC Production PR Utility UT Store ST Human Resource HR 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.
6.0	REFERENCES                                                                                                                                                                               Not Applicable

7.0	ANNEXURES
Annexure No.		Title of Annexure	Format No.
Nil

8.0	ABBREVIATIONS

Abbreviations	Full Forms
SOP	Standard Operating Procedure
XXX	Company Name
No.	Number
QA	Quality Assurance
QC	Quality Control
PR	Production
EN	Engineering
ST	Store
HR	Human Resource
Sign	Signature

 9.0    DISTRIBUTION

Master Copy	Quality Assurance Department
Controlled Office Copy No. 1	Head Quality Assurance
Controlled Office Copy No. 2	Head Quality Control
Controlled Office Copy No. 3	Head Production (Tablet)
Controlled Office Copy No. 4	Head Production (Liquid)
Controlled Office Copy No. 5	Head Production (External)
Controlled Office Copy No. 6	Head Production (Soap)
Controlled Office Copy No. 7	Head Personnel & Administration
Controlled Office Copy No. 8	Head  Warehouse ( Main)
Controlled Office Copy No. 8	Head  Warehouse ( External)
Controlled Office Copy No. 9	Head Information and Technology
Controlled Office Copy No. 10	Head Engineering

10.0	REVISION HISTORY
S.No.		Revision No.	Effective Date	Reason for Revision	Details of Change	Authorized By (sign & Date)

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