Newsletter - January 19, 2017
FDA Faces Many Challenges in Auditing Foreign GMP Sites
A GAO report on FDA’s foreign inspections paints a very dire picture for the current status of inspections. There are about 5000 manufacturing sites registered with FDA of which 3000 are located outside of the US; about 1000 of these foreign sites have never seen an FDA audit. With about 40% of finished products and 80% of API manufactured at locations outside the US, GAO raised concerns about the effectiveness of FDA’s resources to monitor quality of the US drug supply chain. Read More
Convert or Inactivate DMFs Before the May Deadline for Electronic DMFs
Starting 5 May 2017, FDA will require all DMFs be submitted only in the electronic CTD format creating a huge burden on owners of non-critical DMFs. Converting to eCTD format requires special skills, software and resources, the cost of which could be prohibitive to small manufacturers. To avoid the hassle of converting to eCTD format, owners of DMFs can simply inactivate their paper DMFs before the deadline and use other mechanisms to share the information. Read More
FDA Faces Many Challenges in Auditing Foreign GMP Sites
A GAO report on FDA’s foreign inspections paints a very dire picture for the current status of inspections. There are about 5000 manufacturing sites registered with FDA of which 3000 are located outside of the US; about 1000 of these foreign sites have never seen an FDA audit. With about 40% of finished products and 80% of API manufactured at locations outside the US, GAO raised concerns about the effectiveness of FDA’s resources to monitor quality of the US drug supply chain. Read More
Convert or Inactivate DMFs Before the May Deadline for Electronic DMFs
Starting 5 May 2017, FDA will require all DMFs be submitted only in the electronic CTD format creating a huge burden on owners of non-critical DMFs. Converting to eCTD format requires special skills, software and resources, the cost of which could be prohibitive to small manufacturers. To avoid the hassle of converting to eCTD format, owners of DMFs can simply inactivate their paper DMFs before the deadline and use other mechanisms to share the information. Read More
