Comments on: FDA May Outsource Some Foreign Inspections http://www.pharmalot.com/2008/06/fda-may-outsource-some-foreign-inspections/ News, Comment and Conversation Fri, 10 Feb 2012 20:30:06 +0000 http://wordpress.org/?v=2.6.2 By: CMC guy http://www.pharmalot.com/2008/06/fda-may-outsource-some-foreign-inspections/#comment-360098 CMC guy Sat, 14 Jun 2008 00:41:09 +0000 http://www.pharmalot.com/?p=14113#comment-360098 Not clear would be a benefit as would require experienced and trained Inspectors who need to act as teams. If we could get/build a strong core that had consistency would help. Wonder what authority would they have to enforce changes and doubt would be taken as seriously as an Agency Inspectorate? Actually would be better to seek "ICH" sponsored inspectors supported by FDA/EMEA/MHLW+ since are dealing with global issues. Most importantly China, and India in less ways, need to modernize their Systems so they can become a partner (and not a self serving hinderence as seen with heperin). Probably more than anything Sponsors need to take the responsibilities to properly select and monitor the supply chains, as is basic cGMP. Companies should be doing own or have third party audits with cooperation and direct info flow to FDA (ICH). FDA still should do spot checks but would not have to necessary visit all places every two years. Critics who don't trust industry and/or pharma would not accept but IMO could be done effectively. Not clear would be a benefit as would require experienced and trained Inspectors who need to act as teams. If we could get/build a strong core that had consistency would help. Wonder what authority would they have to enforce changes and doubt would be taken as seriously as an Agency Inspectorate? Actually would be better to seek “ICH” sponsored inspectors supported by FDA/EMEA/MHLW+ since are dealing with global issues. Most importantly China, and India in less ways, need to modernize their Systems so they can become a partner (and not a self serving hinderence as seen with heperin).

Probably more than anything Sponsors need to take the responsibilities to properly select and monitor the supply chains, as is basic cGMP. Companies should be doing own or have third party audits with cooperation and direct info flow to FDA (ICH). FDA still should do spot checks but would not have to necessary visit all places every two years. Critics who don’t trust industry and/or pharma would not accept but IMO could be done effectively.

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