Radiopharmaceutical Production

Site Master File

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Site Master File

The Site Master File (SMF) is

prepared by the pharmaceutical
manufacturer and should contain
specific information about the
quality management policies and
activities of the company, 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.

Contents

Scope of the Site Master File

Contents of the Site Master File
Example Site Master File

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Radiopharmaceutical
Production

Scope of the Site Master File

Site Master File

Contents
Scope of the Site Master
File
Contents of the Site
Master File
Example Site Master File

SITE MASTER FILE (SMF) provides

a general overview of the site and its
operations.
The Site Master File concept has
been developed by PIC/S and has
become a standard expectation of
inspectors. Following a recent
revision of the explanatory notes by
PIC/S, it has been proposed that the
status of the Site Master File is more
formally linked to the regulatory
framework.

A more complete description of the site master file

requirements can be found in the PHARMACEUTICAL
INSPECTION CONVENTION PHARMACEUTICAL
INSPECTION CO-OPERATION SCHEME (PICS)
documents here.
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PICS Site Master File

Radiopharmaceutical
Production

Site Master File

Contents of the Site Master File

The Contents of an example site master file as required under the
PICS guidelines can be found by following the arrow.

Contents
Scope of the Site Master

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File
Contents of the Site
Master File
Example Site Master File

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Another example of the

table of contents of a site
master file is given on the
following pages

Site Master File Contents

Contents of the Site Master File

Radiopharmaceutical
Production

Site Master File

Contents
Scope of the Site Master
File
Contents of the Site
Master File
Example Site Master File

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Table of Contents
1. General Information
1.2 Introduction
1.3 Products produced
1.4 Senior Management
1.5 General Information on
the site
1.6 Quality Management
System
2. Personnel
2.1 Employees
2.2 Organization chart
2.3 Training
2.4 Health and hygiene
requirements for personnel
2.4.1 Personnel hygiene
requirements including
clothing
2.4.2 Health requirements for
personnel

3. Premises and
Equipment
3.1 Plans
3.1.1 General Location of
the Site
3.1.2 Site and Building Plan
3.1.3 Detailed Building
Plans
3.1.4 Personnel, Material
and Product Flows
3.2 Production and
Packaging Areas
3.3 Premises mentioned by
building references and
activities
3.4 Heating, Ventilation and
Air Conditioning

Contents of the Site Master File

Radiopharmaceutical
Production

Site Master File

Contents
Scope of the Site Master
File
Contents of the Site
Master File
Example Site Master File

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3.5 Zoning
3.8 Manufacturing
3.5.1 Zoning of Manufacturing
Equipment
classification
3.9 Control Laboratory
3.5.2 Non Viable particles
Equipment
3.5.3 Viable particles /settle
3.10 Maintenance and
plates
Calibration
3.5.4 Viable particles /active
4. Documentation
air sampling
4.1 General
3.5.5 Viable particles /contact
4.2 SOPs
plates
4.3 Computerized system
3.6 Highly toxic, hazardous,
4.3.1 Production
sensitizing agents
4.3.2 Quality Control
3.7 Water
Laboratory
3.7.1 Water types and
4.3.3 Warehousing
sampling points
5. Production
3.7.2 Alert levels for water
5.1 Process Flow
types
5.2 Operations for handling
3.7.3 Action levels for water
materials and products
types
5.3 Rejected materials and
products
5.4 Validated Processes

Radiopharmaceutical
Production

Site Master File

Contents
Scope of the Site Master
File
Contents of the Site
Master File
Example Site Master File

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Contents of the Site Master

File
6. Quality Control
6.1 Release of batches
6.2 Brief description of Quality
Control System
7. Contract manufacture
and analysis
7.2 Analysis Contracted out
8. Distribution, Complaints
and Product Recalls
8.1 Arrangements for
handling complaints and
recalls
8.2 GMP-related complaints
8.3 GMP-related product
recalls

9. Regulatory inspections
and self-inspections
9.1 Inspection conducted by
national authorities
9.2 Inspections conducted
by foreign authorities
9.3 Self-Inspections during
the last year

Radiopharmaceutical
Production

Site Master File

Example Site Master File

An model for the preparation and an example of the site master
file can be found by following the arrow

Contents
Scope of the Site Master
File
Contents of the Site

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Model Site Master File

Master File
Example Site Master File

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Example Site Master File

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