1.0	OBJECTIVE
	To describe the procedure for Preparation, Review and Approval of Standard Operating Procedure
2.0	SCOPE

     This procedure is applicable to all SOPs at N.S PHARMA.

3.0	RESPONSIBILIES
	Concerned area production pharmacists, Production manager/Quality Control Manager & Quality Assurance Manager.
4.0	DEFINITIONS & ABBREVIATIONS
	SOP: Standard Operating Procedure BMR: Batch Manufacturing Record Etc.
5.0	Procedure (Preparation of Standard Operating Procedure): 5.1 All SOP’s shall be as per this SOP Format 5.2 Each page including Annexure shall bear company logo. 5.3 All the SOP’s shall consist of Header Content. 5.4 The Header part of each SOP shall remain common for all pages excluding format & Annexure pages. 5.5 The Header part of the SOP shall consist of the following|:

     5.5.1    Company Logo: Logo of N.S Pharma shall be present in left top box.

     5.5.2    Company Name:  The name of N.S PHARMA shall be written on the top box right to the company logo box. It should be of font size 16, Arial, bold & capital alphabets.

     5.5.3    Department Name: relevant department name in which the SOP is valid is written left box in second row of the header format. It should be of font size 12, Arial, normal.

     5.5.4     Standard Operating Procedure shall be printed in Arial letters. Font Size: 12, Style:  Normal 

     5.5.5     Title: The title of SOP shall be in Arial letters. Font Size: 12, Style:  Normal, Bold Sentences Case. It should be self descriptive.

     5.5.6     Page No: The page number is given on right side in 3^rd row.

    5.5.7      SOP No.:  Each sop number is given as document No. on left side of 3^rd row.

     5.7.1            Numbering criteria of SOP:

                SOP number shall consist of 12 characters.

Ø  First two characters, ‘N.S’ denotes "N.S Pharma".

Ø  Third, Sixth and Ninth characters denotes oblique (/).

Ø  Fourth and Fifth Characters denote the concerned Department in which the SOP is valid e.g. “PR” denote production, “QA” denotes Quality Assurance and “QC” denotes Quality Control.

Ø  Seventh to Eighth characters show the relevant category of the SOP i.e. “EC” shows Equipment, machinery & area cleaning SOPs, “GE” shows general SOPs and OP” shows Operational SOPs.

Ø  Tenth, Eleventh and Twelfth characters denote serial number of SOP, starting from “001"onwards of the relevant category.

Ø  E.g. First new SOP of Production for cleaning at N.S PHARMA location shall have SOP number as   NS/PR/EC/001.

5.5.8   Approval Date: It is the date on which Director Technical approves the SOP. It is written on left side of the fourth row.

 5.5.9   Effective Date: The effective date is the Date from which the SOP shall be effective. Training shall be given to all concerned personnel before effective date of the SOP. It is written in the center of 4^th row. 

5.5.10   Review Date: This is the Date, before which the SOP shall be reviewed. Every two years from the effective date, SOP shall be reviewed. In case any need arises, SOP shall be reviewed, before the defined review period through a change control procedure.

 5.5.11 Prepared by:  Person preparing the SOP shall sign the SOP. Designation shall be printed with Department.

5.5.12 Reviewed by:  Person reviewing the SOP shall sign the SOP. Designation shall be printed with Department.

   

         

5.5.1.10 Approved by: QA MANGER is liable to approve SOPS of Production & QC departments. Director technical is liable to approve all SOPs of Q.A DEPARTMENT. He will sign on each SOP.

5.6       A footer is given on each page. The footer contains:

5.6.1     Revision No.: It shows that how many times the SOP has been revised i.e. “00” means it has not been revised yet. “01” will show that this SOP has been changed for once. “02” will show the SOP has been changed for twice and so on.

5.6.2   Revision Date. In case revision is done in SOP then the revision date is also written.

                                         

5.6      Content Part:

5.6.1     All SOPs shall contain the following sections:

                      i.        OBJECT

                    ii.        SCOPE

                   iii.        RESPONSIBILITIES

                   iv.        DEFINITIONS & ABBREVIATIONS

                    v.        MATERIALS AND EQUIPMENTS

                   vi.        PROCEDURES

                 vii.        REFRENCES

                viii.        REQUIRED DOCUMENT

                   ix.        LIST OF RECIPIENTS

The details of the eleven sections shall be as follows:

5.6.1.1   OBJECT:

This section shall describe the justification for the preparation of the SOP and what is expected from it.

5.6.1.2    SCOPE:

   This section shall indicate the applicability of the SOP for its intended use.

5.6.1.3 RESPONSIBILITIES:

This section shall indicate responsibilities of the personnel for the intended activity.

5.6.1.4            DEFINITIONS & ABBREVIATIONS:

 The Abbreviations used in the SOP shall be described in this section.

5.6.1.5            MATERIALS & EQUIPMENTS:

The materials and equipment intended to be used shall be written in this section.

5.6.1.6 PROCEDURES:

This section shall cover stepwise activities performed and conditions / precautions required for implementing the SOP. 

SOP text shall be written in simple and clear language in Font Style, "Arial", with a Font size of ‘10’ and space between the lines shall be 1.5 lines. A4 size white paper shall be used for printing.

Bold letters shall be used for Heading and / or Subheadings.

All the signatures with the date

All SOP shall be written in English language.

5.6.1.7   REFERENCES:

       References shall be mentioned in the procedure if applicable.

                

5.6.1.8            REQUIRED DOCUMENTS:

            All relevant records linked with this SOP shell be mentioned here.

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5.6.1.10 LIST OF RECIPIENTS

1-    Production Manager

2-    Production  Pharmacist of relevant area

3-    Operator of relevant area

4-    Quality Assurance Manager