To lay down procedure for preparation, review, approval, issuance & retrieval of Standard Operating Procedure. (SOP)
This procedure is applicable to preparation of SOP for all the cGMP activities.
The procedure is described further into sub parts. i.e. Preparation, Review , Approval, Distribution, Retrieval, & retention.
Structurally SOP divided into three parts. Header, Footer & Body
4.1 Header of SOP
Title:A unique title shall be given to each SOP. The title shall be comprehensive in short. The title shall indicate the purpose of SOP very clearly and briefly.
SOP Numbering System
Where XXX = Prefix code of a department i.e QA,QC, ADL, PRD
NNN = Sequential Number of department SOP like 001,002 onwards
RR = Revision number of SOP, start from 00, 01, 02, 03
For new SOP , revision number shall be given as 00.
Supersedes: The SOP No. of previous version of SOP shall be mentioned & in case of new SOP, mention “N/A”.
Example: If SOP No. PKG-001/01 is revised and PKG-001/02 is the new SOP No. Then PKG-001/01 shall appear in the column of supersedes.
Effective Date: Effective date is the date from which the SOP shall be implemented. It shall be mentioned in DD.MM.YY or DD/MM/YY (YYYY) format.
Next Review Date: The date on which the SOP shall be reviewed. Usually it can be 2 or 3 years as per different company policy ( 2 years ± 1 month OR 3 years ± 1 month). It shall be mentioned in DD.MM.YY or DD/MM/YY (YYYY) format.
Example: If effective date is 01.01.18 then next review date shall be “01.01.20” for biennial review period.
In case revision is not required after Biennial / triennial review of the SOP, user department head shall write extended up to date and shall sign.
Page No. It should be x of y format. Where x is serial number of page & y is the toal pages of SOP. i.e 01 of 12, 02 of 12
Header should be like this
|Company Name |
|Standard Operating Procedure|
|Effective Date:||Next Review Date:|
4.2 Content of the SOP
Purpose / Objective: Mention the intended use of the SOP in this column. It is a statement, which justifies the need of the SOP.
Scope: Mention the application of the SOP in this section. It shall describe the extent of areas covered by the SOP.
Responsibility: Mention the responsibilities in brief, but with clarity on ownership of individuals / departments in this column.
Distribution: List of individuals/ departments to whom a controlled copy of the approved SOP shall be issued.
Definition of Terms: The new/ uncommon terms those are used in the SOP shall be defined in this section.
Abbreviation: Write full name of all Short forms used in SOP.
Outline of the logical steps & step by step instructions to be carried out to complete the purpose of the SOP.
Wherever required, give example or attachment for more clarification. Each step of the activities / operations shall be explained stepwise.
A brief history of changes made in the SOP shall be written in this section.
In case of New SOP, mention as “New SOP”
During each revision, history of changes shall be added in detail to the existing history
4.3 Footer of SOP
Footer shall consist of 4 columns of Prepared by, Reviewed By & Approved By.
|Prepared By||Reviewed By||Approved by|
|Sign & Date|
Here prepared by shall be User Dept. Reviewed By shall be User Dept. Head & Approved By shall be QA Head/Designee & Quality Head.
4.4 General Guidelines For Preparation of the SOP:
It is preferable to use positive sentence structure in the SOP.
All the SOP’s shall be written in word format file and shall be printed on one side of the A4 size page.
|Font size||Font||Font Style||Colour||Case||Alignment||Line Spacing|
|Titles||12||Times New Roman||Bold||Auto||Sentence||Left||Single|
|Text||12||Times New Roman||Regular||Auto||Sentence||Justified||Single|
|Numbering||12||Times New Roman||Bold||Auto||—||Left||Single|
Page Set Up
|Paper size:||A4 210 x 297 mm (However other paper size may be used where required particularly for attachments)|
|Orientation:||Portrait (However landscape orientation may be used where required particularly for attachments)|
|Headers and Footers||Different first page *|
|*Note: As the header is different for first page, details of the headers shall be mentioned on first page header and header for the second page onward separately, at the time of writing SOP.|
4.5 Review and Approval Procedure
A draft copy of the SOP shall be circulated to review its adequacy to all concerned Dept. as follows. :
In case of Hard Copy: A draft hard copy should have a water mark “DRAFT” on each page. Print out of draft copy shall be made on both side of page.
In case of Soft Copy : Originator shall share soft copy of draft SOP electronically. Review in soft copy shall be done by using track change option. After electronical review of SOP, reviewed copy shall be transferred to electronic data folder.
The originator, for inclusion or exclusion in the final copy of SOP, shall evaluate all comments raised during the checking procedure and shall destroy the draft copies (Soft copy and hard copy) & final copy shall be forwarded to User Dept. Head.
User Department Head shall check the SOP for verification of content and shall circulate for final signature.
4.6 Issuance & Implementation of SOP
After approval of SOP, user Department Head / Designee shall give training to all concerned persons in all relevant department & after completion of Training, along with training record , final signed copy shall be submitted to QA Dept. Final signed copy shall be stamped as “MASTER COPY” which shall be retained with QA.
QA shall take required photocopies as per the distribution list of the SOP from original copy & Revised controlled copies of SOP shall be distributed to each department & shall make entries in issuance log.
Put the “CONTROLLED COPY” stamp in on the top of the right side of first page of the SOP containing issued by sign, date of issuance and copy number and put the “CONTROLLED” stamp in on the top of the right side of remaining pages containing copy number.
|Date of Issuance|
In case SOP is asked by customer or outside agency or others for reference, it shall be issued as by putting stamp of “REFERNCE COPY” on the top of the right side of each page of SOP.
QA person shall put the “OBSOLETE” stamp in on each page of the original copy in the right corner of the superseded SOP & shall be rtained by QA while all retrieved controlled copies of superseded version shall be destroyed & entries sahll be made in log.
4.7 Discontinuation of the SOP
QA person shall put the “VOID” stamp on each page of the original copy at right side of the discontinued SOP & shall retain within QA while all issued copies shall be retrievd back & destroyed.
4.8 Preparation of SOP Index
SOP index is the list of SOPs which shall be maintained Dept.wise & it shall be updtaed in case of any new SOP addition, deltion, revision.
|Sr. No||Title||SOP NO.||Version No.||Effective Date||Next Review Date||Remarks (if any)|
5. Distribution of SOP
All concerned Dept.
SOP : It is the abbreviated form of “Standard Operating Procedure”.
SOP is set of instructions ongoing or reteospective activity given step by step.
PRD : Production
QA : Quality Assurance
ADL : Analytical Development Lab.
Dept. : Department
8. History: New SOP
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