Preparation of Site Master File

  

1.0           Purpose

1.1            To define the procedure for the preparation of Site Master File.

2.0           Scope

2.1         The is applicable for preparation of Site Master File in "NAME" Pharmaceuticals Ltd.

 

3.0           Responsibility

3.1            Officer QA or above shall be responsible to prepare the Site Master File.

3.2            Officer, Engineering /above shall be responsible for checking of Site Master File.

3.3            Head of production and are responsible to review the Site Master File.

3.4            Head of Quality Assurance will approve the Site Master File.

 

4.0           Abbreviations and Definitions

4.1            Site Master File: A Site Master File , also referred to as "SMF",  is a document prepared by the manufacturer containing specific and factual GMP information about the production and/or control of pharmaceutical manufacturing operations carried out at the named site and any closely integrated operations at adjacent and nearby buildings

 

5.0           Materials and Equipment

5.1            Not Appreciable

6.0           Precaution / Health and Safety Considerations

6.1            Not Appreciable

 

7.0           Procedure

7.1            Site Master File Master File shall be prepared as per given template in Annexure-I

7.2            Site Master File shall contain the following contents as per WHO technical report series, No. 961, 2011, Annex 14

Ø General information of the manufacturer

Ø Quality management system of the manufacturer

Ø Personnel

Ø Premises and equipment

Ø Documentation

Ø Production

Ø Quality control

Ø Distribution, complaints, product defects and recall

Ø Self inspection

Ø References

Ø Change history

7.3            Site Master File shall be reviewed annually. If any amendment may be occurred in guidelines then the documents will be reviewed.

7.4            Site Master File shall also contain following Annex if require.

Annex 1: Copy of valid manufacturing authorization

Annex 2: List of dosage forms manufactured including the International Non-proprietary Names (INN) or common name (as available) of APIs used

Annex 3: Copy of valid GMP Certificate

Annex 4: List of contract manufacturers and laboratories including the addresses and contact information, and flow charts of the supply chains for these outsourced activities

Annex 5: Organizational charts

Annex 6: Layouts of production areas including material and personnel flows, general flow charts of manufacturing processes of each product type (dosage form)

Annex 7: Schematic drawings of water systems

 Annex 8: List of major production and laboratory equipment

8.0           Reference Document

8.1            WHO Technical Report Series, No. 961, 2011Annex 14.

 

9.0           Annexure

9.1            Annexure –I      :           Template of Site Master File

10.0        Revision History

 

Revision No.	Brief reason for the revision	Effective Date	Remarks
01	New

 

11.0        Training

11.1       Head of Quality Assurance or his nominee is responsible to conduct a training session on this  SOP.