Site Master File (V3.0)
Site Master File (V3.0)
Site Master File (V3.0)
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Guidance for the Preparation of a Site
Master File
Version 3.0
Drug Sector
Saudi Food & Drug Authority
Kingdom of Saudi Arabia
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Drug Sector
Vision
To be the leading regional Drug Regulatory Authority for pharmaceuticals and cosmetic products, with
professional excellence and services that contribute to the protection and advancement of public health in
the Kingdom of Saudi Arabia.
الرؤية
ويقدم خدماته مبهنية ممتزية تسهم يف حامية وتعزيز،أن يكون قطاع ادلواء رائداً اقلميي ًا يف الرقابة عىل الدوية ومس تحرضات التجميل
.الصحة يف اململكة العربية السعودية
Mission
Protecting public health by ensuring safety, quality, efficacy and accessibility of human, veterinary drugs and
biological products, and safety of cosmetics, through administration of a national regulatory system which is
consistent with international best practice. Through our mission, we also provide accurate and scientific-
based information to the public and healthcare professionals.
الرساةل
حامية الصحة العامة من خالل ضامن أمان وجودة وفعالية وتوفر الدوية البرشية والبيطرية واملنتجات احليوية وسالمة مواد التجميل
عرب تطبيق نظام وطين للرقابة متوافق مع أفضل املامرسات ادلولية وتقدمي املعلومات ادلوائية املبنية عىل أسس علمية للعامة واملهنيني
.الصحيني
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Document Control
Version Date Author(s) Comments
1.0 23/12/2009 Inspection department Initial draft for internal consultation
2.0 06/01/2010 Inspection department Published for comments
2.1 31/08/2010 Inspection department Final
Inspection department This update includes new reference:
3.0 3/10/2016 The reference changed from MHRA to
PIC/S
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Contents
1. Introduction ....................................................................................................................................... 6
2. Purpose .............................................................................................................................................. 6
3. Scope ................................................................................................................................................. 7
4. Content of Site Master File ................................................................................................................. 7
5. Annex ................................................................................................................................................ 8
6. Reference ......................................................................................................................................... 16
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1. Introduction
This document gives guidance to product license holders regarding factual information on the
site at which their products are manufactured and which are inspected by the Saudi Food and
Drug Authority. The Site Master File is prepared by the pharmaceutical manufacturer
and should contain specific information about the quality management policies and activities
of the site, the production and/or quality control of pharmaceutical manufacturing operations
carried out at the named site and any closely integrated operations at adjacent and nearby
buildings. If only part of a pharmaceutical operation is carried out on the site, a Site Master
File need only describe those operations, e.g. analysis, packaging, etc.
When submitted to the Authority, the Site Master File should provide clear information on
the manufacturer’s GMP related activities that can be useful in general supervision and in
the efficient planning and undertaking of GMP inspections.
A Site Master File should contain adequate information but, as far as possible, not exceed 25-
30 pages plus appendices. Simple plans, outline drawings or schematic layouts are preferred
instead of narratives. The Site Master File, including appendices, should be readable when
printed on A4 paper sheets.
The Site Master File should be a part of documentation belonging to the quality management
system of the manufacturer and kept updated accordingly. The Site Master File should have
an edition number, the date it becomes effective and the date by which it has to be reviewed.
It should be subject to regular review to ensure that it is up-to-date and representative of
current activities. Each Appendix can have an individual effective date, allowing for
independent updating.
2. Purpose
The aim of these Explanatory Notes is to guide the manufacturer of medicinal products in the
preparation of a Site Master File that is useful to the Authority in planning and conducting
GMP inspections.
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3. Scope
These Explanatory Notes apply to the preparation and content of the Site Master File.
These Explanatory Notes apply for all kind of manufacturing operations such as production,
packaging and labelling, testing, relabeling and repackaging of all types of medicinal
products. The outlines of this guide could also be used in the preparation of a Site Master File
or corresponding document by Blood and Tissue Establishments and manufacturers of Active
Pharmaceutical Ingredients.
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5. Annex
- Names and street addresses of the site, buildings and production units
located on the site;
- List of GMP inspections of the site within the last 5 years; including
dates and name/country of the Competent Authority having performed
the inspection. A copy of current GMP certificate (Appendix 3).
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2. Quality Management System of the Manufacturer
2.1 The quality management system of the manufacturer
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3. Personnel
- Short description of plant; size of the site and list of buildings. If the
production for different markets, i.e. for local, Saudi Arabia, GCC
Countries, etc. takes place in different buildings on the site, the
buildings should be listed with destined markets identified (if not
identified under 1.1);
- Lay outs and flow charts of the production areas (in Appendix 6)
showing the room classification and pressure differentials between
adjoining areas and indicating the production activities (i.e. compounding,
filling, storage, packaging, etc.) in the rooms;
- Lay-outs of warehouses and storage areas, with special areas for the
storage and handling of highly toxic, hazardous and sensitizing
materials indicated, if applicable;
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4.1.1 Brief description of heating, ventilation and air conditioning (HVAC)
systems
4.2 Equipment
5. Documentation
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6. Production
6.1. Type of products
(References to Appendix 1 or 2 can be made):
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7. Quality Control (QC)
- Description of the Quality Control activities carried out on the site in
terms of physical, chemical, and microbiological and biological testing.
8.1 Distribution (to the part under the responsibility of the manufacturer)
9. Self-Inspections
- Short description of the self- inspection system with focus on criteria
used for selection of the areas to be covered during planned
inspections, practical arrangements and follow-up activities.
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Appendix 1 Copy of valid manufacturing authorization
Appendix 2 List of dosage forms manufactured including the INN-names or
common name (as available) of active pharmaceutical ingredients
(API) used
Appendix 3 Copy of valid GMP Certificate
Appendix 4 List of contract manufacturers and laboratories including the
Addresses and contact information, and flow-charts of the supply-
chains for these outsourced activities
Appendix 5 Organizational charts
Appendix 6 Lay outs of production areas including material and personnel
flows, general flow charts of manufacturing processes of each
product type (dosage form)
Appendix 7 Schematic drawings of water systems
Appendix 8 List of major production and laboratory equipment
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6. Reference
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