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The Site Master File (SMF) provides key information about a manufacturing site's quality management systems, personnel, facilities, equipment, operations, and change control. The SMF includes details on quality policies, production activities, suppliers, equipment, premises utilities, documentation, distribution, complaints handling, and self-inspections. It aims to help regulatory authorities efficiently plan and conduct GMP inspections. The SMF should be regularly reviewed and updated to ensure accurate representation of current activities.
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100% found this document useful (1 vote)
436 views12 pagesOn Site Master File
The Site Master File (SMF) provides key information about a manufacturing site's quality management systems, personnel, facilities, equipment, operations, and change control. The SMF includes details on quality policies, production activities, suppliers, equipment, premises utilities, documentation, distribution, complaints handling, and self-inspections. It aims to help regulatory authorities efficiently plan and conduct GMP inspections. The SMF should be regularly reviewed and updated to ensure accurate representation of current activities.
Uploaded by
Md.Mahbubul AlamCopyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPT, PDF, TXT or read online on Scribd
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Site Master File
Site Master File (SMF)
The SMF is prepared by the pharmaceutical manufacturer
and should contain specific information about
quality management policies and activities of the site
production and/or quality control of pharmaceutical
manufacturing operations carried out at the named site
any closely integrated operations at adjacent and
nearby buildings.
If only part of a pharmaceutical operation is carried out on
the site, a SMF need only describe those operations,
e.g. analysis, packaging, etc.
Site Master File (SMF)
SMF should provide clear information on the
manufacturer’s GMP related activities useful in general
supervision & in efficient planning and undertaking of GMP
inspections.
A SMF 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
including appendices, should be readable when printed
on A4 paper sheets.
Site Master File (SMF)
The SMF should be a part of documentation belonging to
the quality management system of the manufacturer and kept
updated accordingly.
The SMF should have an edition number, effective date and
reviewed date.
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.
Site Master File (SMF)
PURPOSE : to guide the manufacturer of medicinal products
in the preparation of a SMF that is useful to the regulatory
authority in planning and conducting GMP inspections.
SCOPE: to the preparation and content of the SMF.
Manufacturers should refer to regional / national regulatory
requirements to establish whether it is mandatory for
manufacturers of medicinal products to prepare a SMF.
Site Master File (SMF)
CONTENT OF SITE MASTER FILE (according to WHO)
1. GENERAL INFORMATION ON THE MANUFACTURER
1.1 Contact information on the manufacturer
1.2 Authorized pharmaceutical manufacturing activities of the
site
1.3 Any other manufacturing activities carried out on the site
2. QUALITY MANAGEMENT SYSTEM OF THE MANUFACTURER
2.1 The quality management system of the manufacturer
2.2. Release procedure of finished products
2.3 Management of suppliers and contractors
2.4 Quality Risk Management (QRM)
2.5 Product Quality Reviews
Site Master File (SMF)
CONTENT OF SITE MASTER FILE
3. PERSONNEL
4. PREMISES AND EQUIPMENT
4.1 Premises
4.1.1 Brief description of heating, ventilation
and air conditioning (HVAC) systems
4.1.2 Brief description of water systems
4.1.3. Brief description of other relevant
utilities, such as steam, compressed air, nitrogen, etc.
4.2 Equipment
4.2.1 Listing of major production and control
laboratory equipment with critical pieces of
equipment
4.2.2 Cleaning and sanitation
4.2.3 GMP critical computerized systems
Site Master File (SMF)
CONTENT OF SITE MASTER FILE
5. DOCUMENTATION
6. PRODUCTION
6.1. Type of products
6.2 Process validation
6.3 Material management and warehousing
7. QUALITY CONTROL (QC)
8. DISTRIBUTION, COMPLAINTS, PRODUCT DEFECTS AND RECALLS
8.1 Distribution (to the part under the responsibility of the
manufacturer)
8.2 Complaints, product defects and recalls
9. SELF INSPECTIONS
Site Master File (SMF)
CONTENT OF SITE MASTER FILE
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
Site Master File (SMF)
Reference:
1.WHO Technical Report Series, No. 961, 2011, Annex 14
(WHO Guidelines for drafting a site master file)
2.PIC/S: PE 008-4, 1 Annex, 1 January 2011 (content of the Site
Master File)
3.Eudralex: Volume 4-Good Manufacturing Practices,
Medicinal Products for Human and Veterinery Use (Content of
Site Master File)