Validation Times articles from April 2007

Validation Times archives from April 2007

Total CDER inspections decreased slightly in FY '06, CDRH audits hold steady.(Inspections)
April 1, 2007... Total inspections conducted by Center for Drugs at FDA stood at 2,411 for the fiscal year ended Sept. 30, 2006, a decrease from previous years, which were 2,682 in FY '05 and 2,610 in FY '04, according to the agency's 2006 "Enforcement Story."...

Experimental design has advantages in biopharm: Nayar.(Quality by design)
April 1, 2007... Experiment by design (EbD) provides the most efficient way to define what are critical process variables, and major pharmaceutical companies are utilizing EbD in Six Sigma to define their critical design space of their processes. This wins...

ICH Q3C guidance reduces solvent use to enhance patient safety, Baxter executive says.(Residual solvents)
April 1, 2007... The purpose of International Conference on Harmonization (ICH) Q3C guidance for residual solvents is to recommend "acceptable amounts for residual solvents in pharmaceuticals for the safety of the patient," but does not address all possible...

Companies slow to embrace systems-based audits, analyst says.
April 1, 2007... Many pharmaceutical companies are still resistant to switching over to a systems-based concept of GMP inspections, primarily due to "a lack of upper management commitment and a company culture issue," an industry consultant told a recent...

3-item 483 handed to Gilead Sciences for improper validation protocol.(Human drugs)
April 1, 2007... Gilead Sciences, a sterile small volume parenteral manufacturer located in San Dimas, CA, was written up in a three-item 483 because the company's method validation protocol for anion-exchange HPLC method for identity, assay and impurities for...

Part 11 citations lead 9-item 483 for Interquim SA.(Human drugs)
April 1, 2007... FDA's electronic records and signatures regulation (21 CFR Part 11) was the focus for Interquim SA, Barcelona, Spain, in a 9-item 483 focusing on software and database issues, including a network program that had not been validated since 1989....

Merck biologics manufacturing site nets 4-item 483 for comparability study flaws.(Human drugs)
April 1, 2007... Merck's biologic manufacturing plant in Riverside, PA, received a four-item 483 for no documentation of comparability studies performed during cell banking activities. A July 25, 2005, warning letter was issued, as well. According to the...

Janssen slapped with 8-item 483 for CAPAs, validation procedures.(Medical devices)
April 1, 2007... Janssen Pharmaeceutica, Beerse, Belgium, was slapped with an eight-item 483 in an initial inspection of its medical device manufacturing operations for inadequate validation procedures and improper corrective and preventive action (CAPA)...

Abbott warned for QS violations, poor validation.(Human drugs)
April 1, 2007... Abbott Laboratories' plant in Irving, TX, was warned for violating device Quality Systems regulations in its manufacture of automated clinical chemistry and immunoassay analyzers for the diagnosis of diseases. Some of the violations listed...

ComputeRx/Broncho-Dose warned for 'serious' QS violations, including aseptic processing flaws.(Human drugs)
April 1, 2007... ComputeRx/Broncho-Dose, Stratford, CT, received a warning letter for multiple failures in its quality systems, including failure to have appropriate laboratory determination of satisfactory conformance to final specifications for the firm's...

Access Point Med cited for failure to report Class II recall.(Human drugs)
April 1, 2007... An Oct. 16-19, 2006, audit determined that Access Point Medical, St. Louis, MO, an importer of Rollator mechanical walkers and canes, had initiated a field correction and removal related to reports that the fork on the wheel and did not inform...