Validation Times articles from November 2006

Validation Times archives from November 2006

SOCMA and EFCG call for level playing field for domestic and foreign API manufacturers.(APIs)
November 1, 2006... Increased regulatory oversight of international pharmaceutical firms, particularly those based in India and China, is essential to increase patient safety and regional/national security, according to a joint position paper submitted this year...

Senate HELP Committee holds hearing on creating '21st century FDA'; Kennedy vows oversight in '07.(Legislation)
November 1, 2006... FDA needs expanded authority, greater enforcement powers, more human and financial resources and consistent leadership to do a better job of ensuring drug safety while speeding access to new medications, witnesses told the Senate Committee on...

Sterility assurance submission should have clear terminal sterilization or aseptic process, says OGD's Sweeney.(Sterility)
November 1, 2006... BETHESDA, MD -- When conducting a sterility assurance submission to FDA, it is important "to clearly identify terminal sterilization, aseptic process or both in your submission cover letter or executive summary," and to provide a detailed...

Common problems with BE submissions: poor organization and improper electronic tables.(CMC)
November 1, 2006... BETHESDA, MD -- A senior official from the Division of Bioequivalence (DBE) within the Office of Generic Drugs reported here that common recurring problems with bioequivalence (BE) submissions include poorly organized BE submissions, electronic...

New guidance, e-submissions highlight FDA drug safety initiative.(Drug safety)
November 1, 2006... In anticipation of the Democrats taking control of Congress in January, and the prospect of intense oversight of agency handling of drug and device safety, FDA Deputy Commissioner for Medical and Scientific Affairs Scott Gottlieb, M.D., Nov. 13...

Luitpold slapped with 4-item 483 for lack of assurance of sterilization processes.(Human drugs)
November 1, 2006... Procedures designed by Luitpold Pharmaceuticals, Shirley, NY, to prevent microbiological contamination of drug products did not include adequate validation of the sterilization process, netting the firm a four-item 483. The audit was...

EM Innovations hit with 8-item 483 for quality audits, CAPAS.(Medical devices)
November 1, 2006... Lack of adequate quality audits and corrective and preventive actions (CAPAs) netted an eight-item 483 in a 2006 inspection for the device specification developer EM Innovations, Galloway, OH. Investigators Allison and Jeffrey Sincek from...

Device firm cited for faulty design input requirements, not validating device design.(Analysis of 483s/EIRs for GMP validation issues)
November 1, 2006... OrthoHelix Surgical Designs, Akron, OH, received a nine-item 483 that cited inadequate design input requirements and design plans, and also for failure to validate the device design. The report was written by investigator Laureen Geniusz from...

Bausch & Lomb hit with letter for design plan flaws.(Medical devices)
November 1, 2006... During a March 22 through May 15 inspection of Bausch & Lomb's Greenville, SC-facility, FDA investigators determined the manufacturer of contact lens solutions was not in conformity with the current Good Manufacturing Practice (GMP)...

International Brachytherapy receives warning letter citing validation and CAPAs.(Warning Letter Analysis)
November 1, 2006... During an inspection July 3 through July 6, an FDA inspector determined that International Bracyytherapy, Seneffe, Belgium--a manufacturer of iodine 125 and palladium radioisotope brachytherapy devices--was not in conformity with the current...

Patterson Technology lacking in CAPAs and design control.(Warning Letter Analysis)
November 1, 2006... A May 18 through May 25, FDA investigation determined that Patterson Technology Center, Effingham, IL--a manufacturer of EagleSoft software used for dental image manipulation and storage--was not in conformance with the current GMP requirements...

Nose Breathe hit with letter for design control and design flaws.(Warning Letter Analysis)
November 1, 2006... During a July 25 through Aug. 9 inspection of Nose Breathe, Honolulu, HI--the manufacturer of the Nose Breathe Mouthpiece, Nose Breathe for Heavy Snorer, Nose Breathe Pacifier and Nose Breathe Tongue Positioner--FDA determined the firm was not...