Validation Times articles from January 2008

Validation Times archives from January 2008

ADE inspections drop from fiscal '06, but 150+ ADE inspections expected in FY 2008: Krueger.(FDA inspections)
January 1, 2008... WASHINGTON -- There were 27 voluntary action indicated (VAI) results in post-marketing adverse drug experience (ADE) reporting inspections in fiscal 2007, a drop from 38 for the prior fiscal year, according to a supervisor in the surveillance...

ERA in EU required for previously registered APIs, but negative result doesn't mean marketing authorization denial.(Risk assessment)
January 1, 2008... An environmental risk assessment (ERA) is required in the European Union (EU) for new active pharmaceutical ingredients (APIs), and new uses of previously registered APIs. ERAs are governed by the June 2006 guidance document and the EU's...

Extractable/ leachable 483 observations focus on inadequate studies of leaching phenomena.
January 1, 2008... WASHINGTON -- Common 483 observations involving extractable and leachable chemicals in the production of pharmaceuticals include extractable studies not performed for clarifying filters or validation of maximum lifetime, and extractable and...

Systematic process should be in place for leachable safety assessment: OPS.
January 1, 2008... WASHINGTON -- The Center for Drugs Office of Pharmaceutical Science's (OPS) view on leachables and extractables is that companies should have established a systematic process for leachables safety assessment, exposure thresholds for...

ICH Q7 and EMEA documents establish some guidelines for leachables and extractables.
January 1, 2008... WASHINGTON -- Regulatory guidance on leachable and extractable chemicals in the production of pharmaceuticals includes International Conference on Harmonization guidance Q7, which stated: "Equipment should be constructed so that surfaces that...

Leaching can be avoided with appropriate, effective packaging systems.
January 1, 2008... WASHINGTON -- To avoid leaching issues with pharmaceutical packaging, it is critical that every packaging system be suitable for its intended use and feature adequate protection, safety, compatibility and performance, a senior Baxter Healthcare...

Life Care Technologies cited for flawed software validation.(Medical devices)
January 1, 2008... LifeCare Technologies, Tampa, FL, was hit with an eight-item 483 because the company failed to document structural testing of its Perinatal Information Network (P.I.N.) software system, including independent code reviews. It also lacked...

5-item 483 given to Sunoptic for unvalidated processes.
January 1, 2008... Sunoptic Technologies, Jacksonville, FL, was slapped with a five-item 483 in a 2007 GNP audit because certain processes were not validated and approved according to established procedures. Conducting the audit for the Maitland, FL, District...

Warning letter cites CAPAs, complaints.(Medical devices)
January 1, 2008... During an inspection of Northwest Medical Physics Equipment, Everett, WA, conducted June 20-26, FDA investigators determined that the company's facility was not in conformity with the GMP requirements of the Quality System (QS) regulation. ...

Superior fails to establish procedures for non-conforming product.(Medical devices)
January 1, 2008... An inspection conducted of Superior Products, Cleveland, OH, Oct. 17-31 revealed that oxygen conservers and regulators, medical gas regulators, flow meters, humidifiers, and medical gas fittings manufactured by Superior Products were...