STANDARD OPERATING PROCEDURE1

Definition

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3Introduction

4Introduction

5Introduction

6Introduction

STANDARD OPERATING PROCEDURE

Purpose The purpose of this SOP is to provideprocedure and guidelines forpreparing standard operatingprocedures.

The purpose of this SOP is to provideprocedure and guidelines forpreparing standard operatingprocedures.

Scope This procedure is applicable for allthe SOPs prepared and used by BlissGVS Pharma Ltd., Palghar.

This procedure is applicable for allthe SOPs prepared and used by BlissGVS Pharma Ltd., Palghar.

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Responsibility

Department Executives:To identify the need of SOP and prepare the draft SOP as per the guidelinesprovided in the SOP for SOP.

Head of Department:To check the draft SOP and make necessary changes and forward to QAdepartment 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 therespective 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.

Department Executives:To identify the need of SOP and prepare the draft SOP as per the guidelinesprovided in the SOP for SOP.

Head of Department:To check the draft SOP and make necessary changes and forward to QAdepartment 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 therespective 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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Before writing any SOP, guidelines provided in the SOP for SOP shouldbe followed.

Wherever required manufactures manual should be used as areference for preparing SOPs.

The SOP for Quality assurance, Quality control shall remain commonfor both the manufacturing plot no. 10, 11 & 12.

Before implementing any SOP, proper training should be given by thehead / representative of user department of the SOP.

No changes shall be made in the SOP using pencil, ball pen orcorrection ink, once the SOP is approved by QA.

Precautions:

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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. Continue11

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Annexure: Attachment of related formats, logbooks, drawings, flowchart etc.The recording formats, logbooks, which form a part of SOP, should include formatnumber and reference SOP number. However the SOP number should not include theversion number in the format in order to avoid frequent revision due to SOP revision.

Revision history: Provides the details of the revision.

Distribution List: Details the distribution of controlled, Display copies of the SOP andmaster copy retained with Quality assurance department.

Procedure:

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REVISION NO. SUMMARY OF CHANGE EFFECTIVE DATE

Sr. No. User department No. of copies Copy

Procedure:

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Each page of the SOP should have HeaderBLISS GVS PHARMA LTD.

10 & 12, Dewan Udyog Nagar, Aliyali,Palghar, Maharashtra 401404, India. MASTER STAMP

SOP No.:BQA-001/R10 STANDARD OPERATING PROCEDURE

Effective date:01.06.2014

Supersedes SOP No.:BQA-001/R09 FOR WRITINGSTANDARD OPERATING PROCEDURE

Next review date:31.05.2016Page : 1 of 10

Each page of the SOP should have FooterPrepared by

Sr. Executive QAChecked byManager QC

Approved byManager 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 therequirement will prepare a draft SOP taking adequate precaution to include all thedetails and will follow the guidelines provided in the SOP for SOP.

Wherever possiblemanufacturers 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 whitepaper. 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 toQA 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 indelibleink in the top right box of header table on each page and should be initialed by QAManager.

Based on the distribution requirement, QA will generate the requisite number ofphotocopies.

Photocopies will be stamped as CONTROLLED COPY using violet indelible ink on topcenter of each page, DISPLAY COPY using black indelible ink on top center of eachpage and UNCONTROLLED COPY using violet indelible ink on top center of eachpage 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 berevised earlier.

Each user department will identify the need for the revision or change in the SOPs andprepare a draft SOP taking adequate precaution to include the necessary changesrequired.

User department while following the guidelines provided in the SOP for SOP will alsoinclude 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 offirst 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 SOPfrom which the changes are made.

The final print of the revised SOP will be sent to the concerned department for signatureand 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 ofthe 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 QAdepartment will recall all the distributed controlled and display copies and willstamp on all of the SOPs including the MASTER COPY at the top left in each pageof the SOP having the following text using violet indelible ink.Reviewed by User dept.Approved by Manager QANext review date

After stamping, QA will take the signature of user department and finalapproval by Manager QA with next review date and forwarded to respectiveuser department.

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MASTER INDEXING

A Master index of all the approved SOPs should be prepared department wiseand the controlled copies of the same should be circulated to the respectivedepartments.

Sr. No. Name of SOP SOP No. Effective Date Next Review Date

Prepared byDesignation

Checked byDesignation

Approved byDesignation

Signature & Date Signature & Date Signature & Date

MASTER INDEX OF SOPLIST OF STANDARD OPERATING PROCEDURE DEPARTMENT

Ref. SOP No.: Master Index No.: Effective date:

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Name of the department CodeQuality Assurance BQA-001/R0Warehousing BWH-200/R0Manufacturing:Pessary/SuppositoryTabletsDry syrup

BMF-300/R0BGT-300/R0BGD-300/R0

Engineering BUT-400/R0Administration BAD-500/R0Sanitation and Hygiene BSH-600/R0Quality Control BQC-700/R0General BGR-800/R0

SOP CODING

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