market access market access MAY/09/JUNE

market access
Medical
meeting) expressed their continued commitment to
the program. They decided that 10 successful pMAP
audits would be “sufficient experience” to assess the
results of the pilot. Ultimately, some of the restrictions
might be eliminated if the assessment shows that
multi-purpose audits are:
• Valid.
• Fulfill the requirements under the CMDCAS program.
Another very promising objective arose from this meeting
– the development of a common audit/inspection
report format. A common report format would significantly
reduce the time needed by the AP/Registrar to
prepare the two submissions. This time reduction on
the AP/Registrar’s part would reduce the additional
service fees associated with AP/pMAP audits.
Who should Participate and Why?
Manufacturers who are likely to be inspected by the
FDA and who market products in foreign countries will
benefit from participation in the AP and pMAP program
because they will reduce the overall number of audits/
inspections conducted at their establishment and they
will gain more control over the timing and planning of
the audit/inspection.
Manufacturers who in the past have not been inspected
at two-year intervals might want to consider an AP
inspection for another reason: historic data shows that
regularly inspected establishments are more likely to
be found in compliance with the regulations. Regularly
requesting an AP inspection can increase confidence
in the manufacturer’s quality management system as
well as its conformance to U.S. regulations.
Finally, manufacturers not currently eligible under or
participating in the program are encouraged to voluntarily
host joint inspections by the FDA and a Third
Party. In particular, manufacturers who have received
FDA notification that they are due for an inspection
can greatly help to advance this program by allowing a
third party auditor to join on their next FDA inspection.
maY/09/juNe 1
What is the FDA’s Third Party Inspection Program and pMAP? (continued)
Manufacturers who decide to volunteer for joint
inspections should contact the FDA to request that the
joint inspection will be conducted by an auditor from
their own Registrar/Notified Body. This will assure this
specific Notified Body/Registrar will advance their
auditors through the training program and will be able
to offer independent inspections to their clients in the
near future.
help keep these Programs going
Both the Inspection by Accredited Person Program
and the pilot Multi-Purpose Audit Program are active
and operational. Successful audits/inspections have
been conducted under both programs and plans have
been made to continue expanding these numbers.
FDA and Health Canada remain committed and have
proposed changes and initiatives to promote and
advance both programs. However, more participation
is required to keep these programs alive. Consider
the overall savings to the bottom line and it will be an
easy decision to proactively seek involvement in these
worthy ventures.
For more information, please call toll-free at
1-tUV-rheinland (1-888-743-4652) or visit
www.us.tuv.com.