Bibliography for: "ERA in EU required for previously registered APIs, but negative result doesn't mean marketing authorization denial"

Joseph Pickett "ERA in EU required for previously registered APIs, but negative result doesn't mean marketing authorization denial". Validation Times. FindArticles.com. 17 Dec, 2009. http://findarticles.com/p/articles/mi_hb5677/is_1_10/ai_n29445510/

Validation Times

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Articles in Jan, 2008 issue of Validation Times

• ADE inspections drop from fiscal '06, but 150+ ADE inspections expected in FY 2008: Krueger
  by Joseph Pickett
• ERA in EU required for previously registered APIs, but negative result doesn't mean marketing authorization denial
  by Joseph Pickett
• Extractable/ leachable 483 observations focus on inadequate studies of leaching phenomena
  by Joe Pickett
• Systematic process should be in place for leachable safety assessment: OPS
  by Joe Pickett
• ICH Q7 and EMEA documents establish some guidelines for leachables and extractables
  by Joe Pickett
• Leaching can be avoided with appropriate, effective packaging systems
  by Joe Pickett
• Life Care Technologies cited for flawed software validation
  by Joe Pickett
• 5-item 483 given to Sunoptic for unvalidated processes
• Warning letter cites CAPAs, complaints
  by Rebecca Mashaw
• Superior fails to establish procedures for non-conforming product
  by Rebecca Mashaw