market access market access JULY/08/AUG

market access
Medical
Update on FDA’s Third Party Inspection Program and pMAP (continued)
year to demonstrate compliance with requirements
that are largely harmonized. Participation in the Third
Party Inspection Program will give manufacturers
the opportunity to reduce the number of inspections
conducted to meet FDA and other countries’ regulations,
and to control the scheduling of inspections.
pmap – pilot multi-purpose audit program
The pilot Multi-purpose Audit Program, which was
developed by Health Canada (HC) in cooperation
with the US Food and Drug Administration (FDA), was
introduced in September 2006. The purpose of the
pMAP is to evaluate the effectiveness of performing a
single third party inspection/audit of medical devices
manufacturers’ quality management systems that
would meet the regulatory requirements of Canada
and the United States. The pMAP builds upon the
regulatory programs of both countries, specifically
those aspects which involve the services of third
party quality system auditing organizations: the FDA’s
Inspection by Accredited Person Program and Health
Canada’s CMDCAS program. FDA and HC are intending
to use the audits/inspections under the pMAP as a
learning opportunity to acquire a better knowledge of
auditing/inspection approaches that support several
regulatory objectives.
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While pMAP does not alter or eliminate any previously
established procedures, guidance and regulations of
the AP and the CMDCAS program, it is a program in
itself, which has its own set of rules and requirements.
It is important to note that at the current time, the pMAP
is mandatory for manufacturers who are seeking a
single inspection/audit under the CMDCAS and AP
program.
progress and status of the ap and pmap programs
According to a report by GAO, few inspections of
medical device manufacturing establishments have
been conducted through the AP Inspection Program
and the pMAP. From March 11, 2004 - the date when
FDA first cleared an accredited organization to
conduct independent inspections - through January
2008, only five inspections were conducted under the
AP program and two audits under the pMAP. These
numbers seem to suggest a very limited interest in
these programs, but a close look at the history and the
rules of both programs might reveal other reasons for
the low participation.
While the FDA met their objective to initially accredit
15 third parties by October 2003, very slow progress
has been made in qualifying individual inspectors/
auditors in this program. According to the current
program rules, each auditor has to participate in three
joint inspections with the FDA. The demand in joint
inspections is higher than the number of inspections
offered; the FDA assigns the inspections to APs by a
random draw. The availability of training opportunities
is limited by the number of device manufacturers,
who volunteer to host joint inspections. Training is
also limited by the availability of FDA performance
inspectors, who are qualified to monitor AP auditors