Procedure for assessing the acceptability, in principle, of vaccines ...

Appendix 1 The product summary file
The product summary file (PSF) is a summary dossier containing current information
on the product to be supplied to United Nations agencies. It presents information on
the product composition, manufacturing procedure, testing, stability, labelling, clinical
experience and available post-marketing safety information.
For initial product assessments, a PSF shall be submitted for each vaccine to be
assessed. For combination vaccines, information shall be submitted on each of the
component vaccines and on the combination itself. If a combination vaccine is being
evaluated and the monovalent versions of the antigens contained in the combination
are also being evaluated, the information provided for the monovalent vaccines (up to
concentrated bulk) can be used for the assessment of the combinations or, conversely,
the information on each antigen provided in the PSF of the combination vaccine can
be used to assess the monovalent vaccines (up to concentrated bulk level).
The PSF is expected to contain the following elements:
Chapter 1: General information
1.1 Provide brief information on the company (including name and address of the site,
telephone, fax and 24-hour telephone numbers, and the principal contacts of the
company) and its relation to other sites where steps of the process or testing activities
(for both the active biological components and diluent) may be conducted.
1.2 List pharmaceutical and non-pharmaceutical manufacturing activities carried out
at the site, as licensed by the national regulatory authority. This information shall also
be provided for contracted manufacturers.
1.3 Provide a short description of the site (size, location and immediate environment).
List buildings on the site(s) or provide a site plan, identifying the manufacturing,
control and storage activities in each building.
1.4 State the number of employees engaged in production, quality assurance, quality
control, storage and distribution.
1.5 List outside scientific, analytical or other technical assistance in relation to
manufacture and analysis, including equipment and/or other facility maintenance and
46