FAQ
FAQ GIF

- Why GIF?
The good manufacturing practice, developed for medicinal products for
supplements, medical devices, for medical-surgical, etc.,
provide for the execution of audits to the websites of suppliers of products
influential on the quality, to examine the quality systems implemented and then
determine the level of quality and compliance.
In particular, the recent amendments to the GMP Eu (Part 1 and Part 2)
require that companies holding production licenses
drug monitoring of compliance of GMP by the companies from which
supplies the API. This request is being extended also to
some of the ingredients that will be included in a separate list. Anything beyond
the initial authorization issued to the production site by a
European authorities (certification GMP) includes for drug manufacturers
the systematic execution of audits to all producers of active ingredients used
in their products to check first and then confirm compliance
good manufacturing practice.
Are not exempt from these requirements providers of packaging materials
Primary and secondary laboratories third parties and service providers logisticodistributivi.
From this pressing and onerous request, the proposed solution
implementation of joint audits and sharing of related reports.

- What is GIF?
It 'a working group, formally established, which includes experts
different company, whose purpose is to create / develop synergistic activities between
member companies in the pharmaceutical, chemical, pharmaceutical, food,
nautraceutico, etc. on issues of quality and GMP, as well as promote
innovation and ultimately help to produce those "savings" now more
indispensable than ever to ensure development.
The GIF is actually to fill the role played domestically in Germany
the VFA (Association of the Verband Forschender Arzneimittelhersteller-
Research-based Pharmaceutical the Companies) and Spain from the Forum
Auditorias, which have long since implemented the method of joint audits.

- What is the scenario of GIF?
Considering about 10 external audits per year from a company run average,
about 70 companies participating at the time should run concurrently about 700
audits per year. By calculating an average effort of an auditor for 3 days / audit, the
"Time consuming" auditing company to be around 30 days FTE / year
and a total of 2100 days. A respectable figure!

- What does GIF?
In this specific context, GIF stands as partners in implementing
joint audits with suppliers and as the guarantor of provision in
a controlled and shared between the reports of its member companies.


- Which advantages GIF companies who participate?
In addition to the professional development of individuals involved in terms of
increased knowledge and experience to a formal recognition
professionalism reached, a drastic reduction of working days
dedicated to auditing activities in substantial compliance with the law, making
substantial savings in time and cost.


- What are the benefits for suppliers audited joint?
A drastic reduction in the number of days devoted to support audits
part of different companies and different modes of both executive
evaluation. Consequently, a lower concentration of audits at
and ensuring a more objective evaluation derived from increased
harmonization of the various points to be verified. Indeed savings
important derived incur a much lower number of
audits.


- What is required for companies participating in the GIF in order to have reports
shared?

Respect for the status (registered), participation in activities and
the execution of at least one audit per year on behalf of GIF.


- What results GIF, from March 2006 (the date of incorporation) to 12.2012?
Has performed 241 audits and integrated manner made available to
members of its report. It carried out 28 training interventions.