STANDARD OPERATING PROCEDURE
Definition
Introduction
Introduction
Introduction
Introduction
STANDARD OPERATING PROCEDURE
Purpose
Scope
The purpose of this SOP is to provide
procedure and guidelines for
preparing
standard
operating
procedures.
This procedure is applicable for all
the SOPs prepared and used by Bliss
GVS Pharma Ltd., Palghar.
Responsibility
Department Executives:
To identify the need of SOP and prepare the draft SOP as per the guidelines
provided in the SOP for SOP.
Head of Department:
To check the draft SOP and make necessary changes and forward to QA
department for review.
To check and sign off the master copy of SOP and master indexing of SOP.
QA Executives:
To take a final print of the SOP and submit to concerned departments for the
respective signatures.
To prepare master index of SOP and submit to concerned department for signing.
Manager QA:
To approve the master copy of SOP and master indexing of SOP.
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Precautions:
Before writing any SOP, guidelines provided in the SOP for SOP should
be followed.
Wherever required manufactures manual should be used as a
reference for preparing SOPs.
The SOP for Quality assurance, Quality control shall remain common
for both the manufacturing plot no. 10, 11 & 12.
Before implementing any SOP, proper training should be given by the
head / representative of user department of the SOP.
No changes shall be made in the SOP using pencil, ball pen or
correction ink, once the SOP is approved by QA.
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Procedure:
SOP should be written in simple and lucid language for easy understanding.
The procedure should be such that they can be easily understood and
followed by any person referring the SOP.
Wherever required SOPs should be prepared in the vernacular language for
the use of workmen who do not follow English language.
Quality of SOP SOPs should have only typewritten text in Arial and font size 12.
SOP should be in details and step wise.
Should be free of ambiguity.
Should be simple, easily understood.
Should give complete and actual information.
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Procedure:
All SOPs should contain
Purpose, Scope, Responsibility, Precautions (if applicable), Procedure, Abbreviations,
Annexure, Revision history and Distribution list.
Font style of all subtitles should be in bold and the remaining texts should be in
regular.
Purpose: To describe the reason for preparation of SOP.
Scope: To describe the coverage of SOP.
Responsibility: To define the responsibility for preparation, checking and approval of
the SOP.
Precaution: Safety requirement if any.
Procedure: To give the details of the procedure; subsequent points serially e.g. 1, 2,
3,.....
Abbreviations: The short forms that are used while writing the procedure shall be
listed at the end of procedure.
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Procedure:
Annexure: Attachment of related formats, logbooks, drawings, flowchart etc.
The recording formats, logbooks, which form a part of SOP, should include format
number and reference SOP number. However the SOP number should not include the
version number in the format in order to avoid frequent revision due to SOP revision.
Revision history: Provides the details of the revision.
REVISION NO.
SUMMARY OF CHANGE
EFFECTIVE DATE
Distribution List: Details the distribution of controlled, Display copies of the SOP and
master copy retained with Quality assurance department.
Sr. No.
User department
No. of copies
Copy
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Procedure:
Each page of the SOP should have Header
BLISS GVS PHARMA LTD.
10 & 12, Dewan Udyog Nagar, Aliyali,
Palghar, Maharashtra 401404, India.
SOP No.:
BQA-001/R10
Supersedes SOP No.:
BQA-001/R09
STANDARD OPERATING PROCEDURE
FOR WRITING
STANDARD OPERATING PROCEDURE
MASTER STAMP
Effective date:
01.06.2014
Next review date:
31.05.2016
Page : 1 of 10
Each page of the SOP should have Footer
Prepared by
Sr. Executive QA
Checked by
Manager QC
Approved by
Manager QA
Signature & Date
Signature & Date
Signature & Date
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Procedure: Preparation of new SOP
Each user department to identify the need for the desired SOPs and based on the
requirement will prepare a draft SOP taking adequate precaution to include all the
details and will follow the guidelines provided in the SOP for SOP.
Wherever possible manufacturers manual should be referred while preparing the SOP.
Head of the user department will review the SOP and will make necessary changes /
corrections and will forward the draft copy of the SOP to QA department for review.
After reviewing, QA will prepare the final SOP and take out the print on A4 size white
paper. Forward the SOP to the concerned department for signing the document.
Head of the department will check, sign off and dated the final SOP and will forward to
QA for approval. Manager QA will approve the SOP.
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Procedure: Preparation of new SOP
QA department will stamp the original copy as MASTER COPY using green indelible
ink in the top right box of header table on each page and should be initialed by QA
Manager.
Based on the distribution requirement, QA will generate the requisite number of
photocopies.
Photocopies will be stamped as CONTROLLED COPY using violet indelible ink on top
center of each page, DISPLAY COPY using black indelible ink on top center of each
page and UNCONTROLLED COPY using violet indelible ink on top center of each
page with initials of QA representative.
Before implementation of the SOP - Training with attendance record.
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Procedure: Incorporation of changes
If any changes are required the SOP earlier than the review date, the same may be
revised earlier.
Each user department will identify the need for the revision or change in the SOPs and
prepare a draft SOP taking adequate precaution to include the necessary changes
required.
User department while following the guidelines provided in the SOP for SOP will also
include the reasons for change in the revision history.
Head of the user department will review the SOP and will make necessary changes /
corrections and will forward the draft copy of the SOP to QA department for review.
Revised or amended SOPs will bear their original SOP number with a suffix e.g. in case of
first revision the suffix will be R1.
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Procedure: Incorporation of changes
QA will review the final draft and insert the superseded SOP number of previous SOP
from which the changes are made.
The final print of the revised SOP will be sent to the concerned department for signature
and date.
QA will update the approved SOP number in master index of SOP.
Retrieve all the old SOP copies from the user department before issuing the revised SOP.
Before implementing the revised SOP, training will be given to all the user department of
the SOP and will be briefed on the changes incorporated.
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Procedure: Revision of SOP
SOP should be reviewed every two years.
If any SOP is due for revision and no changes are to be made, then the QA
department will recall all the distributed controlled and display copies and will
stamp on all of the SOPs including the MASTER COPY at the top left in each page
of the SOP having the following text using violet indelible ink.
Reviewed by
User dept.
Approved by
Manager QA
Next review date
After stamping, QA will take the signature of user department and final
approval by Manager QA with next review date and forwarded to respective
user department.
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MASTER INDEXING
A Master index of all the approved SOPs should be prepared department wise
and the controlled copies of the same should be circulated to the respective
departments.
MASTER INDEX OF SOP
LIST OF STANDARD OPERATING PROCEDURE DEPARTMENT
Ref. SOP No.:
Sr. No.
Name of SOP
Master Index No.:
SOP No.
Effective Date
Effective date:
Next Review Date
Prepared by
Designation
Checked by
Designation
Approved by
Designation
Signature & Date
Signature & Date
Signature & Date
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SOP CODING
Name of the department
Quality Assurance
Warehousing
Code
BQA-001/R0
BWH-200/R0
Manufacturing:
Pessary/Suppository
Tablets
Dry syrup
BMF-300/R0
BGT-300/R0
BGD-300/R0
Engineering
Administration
Sanitation and Hygiene
Quality Control
General
BUT-400/R0
BAD-500/R0
BSH-600/R0
BQC-700/R0
BGR-800/R0
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