by
Barbara Kram, Editor | October 02, 2006
US and Canadian authorities
are doing a pilot on
manufacturers' audits
The United States Food and Drug Administration (FDA) and the Therapeutic Products Directorate (TPD) of Health Canada (HC) already have regulatory programs that use the services of third party quality system auditing organizations to perform inspections/audits of medical device manufacturers. Now the authorities are developing a pilot audit program to measure the effectiveness of the arrangement.
The goal is to reduce the overall regulatory burden on device manufacturers. The effort is in keeping with the recently signed Security and Prosperity Partnership (SPP) agreement between Canada, Mexico, and the United States, Health Canada and the Food and Drug Administration. The pilot multi-purpose audit program (PMAP) builds on existing efforts and information provided in a letter the FDA mailed to medical device manufacturers in November 2005 regarding third party inspections.
According to the FDA, the purpose of the PMAP is to evaluate the effectiveness of performing a single third party inspection/audit of medical device manufacturers' quality systems that would meet the regulatory requirements of both countries.
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The PMAP is intended to benefit its participants in a number of ways, including:
*\tfor manufacturers, fewer distractions and interruptions in the work place
*\tfor auditing organizations, the opportunity to better serve their clients by offering a wider range of services that would allow for the fulfillment of both US and Canadian regulatory requirements.
Although the inspections/audits would still encompass two separate but similar sets of requirements, FDA thinks the downtime for a manufacturer will be minimized as a result of one auditing organization conducting the inspections/audits simultaneously.
If you are a qualified auditing organization under both the US FDA and HC programs, you are eligible to participate in this pilot to perform these multi-purpose audits.
More detailed information on the PMAP will be available soon. Find out more at from the FDA at http://www.fda.gov/cdrh/ap-inspection/pmap-letter.html
