Content of a site master file based on the explanatory notes for pharmaceutical manufacturers on the preparation of a site master file of the Pharmaceutical Inspection Convention.
Introduction
The site master file (SMF) is design by the pharmaceutical manufacturer and should contain brief information
about the quality executive policies and activities of the place, the production
and quality control of pharma manufacturing operations carried out
at the named site, and any closely integrated operations at nearby buildings. If
only part of a pharmaceutical operation is carried out on the site, and SMF need
only describe those operations, e.g. analysis, labeling, etc. When submitted
to a regulatory authority, the SMF should provide detailed information on the
manufacturer’s good manufacturing practices (GMP)-related execultiomns that can
be useful in the general supervision and in the efficient planning and undertaking
of GMP inspections. An 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. The SMF,
including appendices, should be readable when printed on paper sheets. 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, 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 annex can have an
individual effective date, allowing for independent updating.
Purpose
The aim of these explanatory
notes are to guide the manufacturer of pharma products in the preparation of an
SMF that is useful to the regulatory authority in planning and organizing GMP
inspections.
Scope
These explanatory notes apply to
the preparation and content of the SMF. Manufacturers should refer to regional
and national regulatory requirements to establish whether it is mandatory for
manufacturers of pharma products to prepare an SMF. These explanatory notes
apply to all kinds of manufacturing operations such as production, labeling, packaging, and testing, relabeling, and repackaging of all types of pharma products. The
outlines of this guide could also be used in the preparation of an SMF or
corresponding document by blood and tissue establishments and manufacturers of
active pharmaceutical ingredients (APIs).
Content of site master file
Refer to the Appendix for the format to be used.
Appendix Content of a site master file
General information on the manufacturer
Contact information on the
manufacturer — name and official address of the manufacturer; — names and
street addresses of the site, buildings, and production units located on the
site; — contact information of the manufacturer including 24-hour telephone
number of the contact person in the case of product defects or recalls; and
— identification number of the site as e.g. global positioning system (GPS)
details, D-U-N-S (Data Universal Numbering System) number (a unique identification the number provided by Dun & Bradstreet) of the site or any other geographical
location system. Authorized pharmaceutical manufacturing activities of the site
— copy of the valid manufacturing authorization issued by the relevant
competent authority or when applicable, reference to the GMP database.
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