Radiopharmaceutical Production
Site Master File
STOP
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
STOP
Scope 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
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.
More
STOP
PICS Site Master File
Contents of the Site Master File
Radiopharmaceutical
Production
The Contents of an example site master file as required under the
PICS guidelines can be found by following the arrow.
Site Master File
Contents
Scope of the Site Master
More
File
Contents of the Site
Master File
Example Site Master File
STOP
•
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
STOP
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
STOP
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
STOP
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
Example Site Master File
Radiopharmaceutical
Production
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
More
Model Site Master File
Master File
Example Site Master File
More
STOP
Example Site Master File
Return to Main Menu