Validation Times articles from July 2007

Validation Times archives from July 2007

Task force recommends new guidance on quality, risk assessment, safety of nanoscale materials.(Nanotechnology)
July 1, 2007... FDA needs to develop guidance and policy in the area of quality, risk assessment and safety as well as many other areas relating to the manufacturing of drug, device and biologic products with nanotechnology, an internal agency task force...

Part 11 undergoing fundamental change within FDA; focus on integrity, not technology is key.(Electronic records)
July 1, 2007... By Validation Times Staff With FDA poised to make changes in its 1997 electronic records/signature regulation (21 CFR Part 11), industry should start preparing to deal more with the integrity of records, with less focus on technology,...

Two-leveled risk assessment team advised to examine complaints.(Risk analysis/complaint-handling)
July 1, 2007... PHILADELPHIA -- Drug manufacturers should adopt a two-level approach to handling complaints and conducting risk analysis, a consultant told a July 23 GNP/validation conference here sponsored by "Pharmaceutical Technology" magazine. Rebecca...

Cordis engineer outlines five-phase approach to using Six Sigma to validate quality system; 'Kaizen' explained.(QS/validation)
July 1, 2007... PHILADELPHIA -- Drug firms eager to deploy "Six Sigma" methods to validation under a quality systems approach may wish to examine what device manufacturer Cordis did, using a five-phased approach. Addressing the PharmTech conference here...

'Lean' Six Sigma seen helping identify risk in manufacturing, QA.(Risk management)
July 1, 2007... PHILADELPHIA -- Lean Six Sigma can help with risk management at drug firms, notably in the areas of batch record release, supplies purchasing and overall compliance activities. That's the message from exFDA inspector Carmen Medina of the...

QA failures including OOS trip up DSM Pharma.(Human drugs)
July 1, 2007... DSM Pharmaceuticals, Greenville, NC, received a 13-item 483 because its quality assurance unit did not capture quality issues, including an out-of-specification (OOS) result that did not initiate a report nor an investigation. The audit...

Forest Pharma handed a 5-item 483 for faulty lab controls.(Human drugs)
July 1, 2007... Forest Pharmaceuticals, St. Louis, MO, was hit with a five-item 483 for laboratory controls not including sound and appropriate test procedures, as well as cleaning and maintenance of equipment. Investigator Gwyn Dickinson from the Lenexa, KS,...

API firm slapped with 483 for calibration and maintenance of equipment.(Human drugs)
July 1, 2007... Oregon Freeze Dry, Albany, NY, was written up in a seven-item 483 because of its inadequate calibration and maintenance of critical equipment used in the manufacture of drug products. The report was written by investigators Terri Dodds,...

CAPA flaws noted in 12-item FDA write-up.(Medical devices)
July 1, 2007... Berkline Corporation, Livingston, TN, received a 12-item 483 because of undocumented corrective and preventive action (CAPA) procedures, and quality system problems, according to a 2006 audit performed by investigator Cheryl Scott from the...

ImmuCell warned for 'serious' GMP deviations.(Human drugs)
July 1, 2007... The pharmaceutical manufacturing firm ImmuCell Corporation, Portland, ME, was determined to be in "serious violation of GMP regulations, according to a June 1 warning letter. Specifically, the drug products did not bear an expiration date...

Avazzia cited for lack of procedures for design changes.(Medical devices)
July 1, 2007... Avazzia, Dallas, TX, the manufacturer of hand-held and battery-operated transcutaneous electro-stimulators (TENS), was found to be out of conformance with the Quality System regulation. The June 20 warning letter stated that the firm failed...

Crystal Reflections written up for lack of validation procedures.(Human drugs)
July 1, 2007... Crystal Reflections International, Green Valley, AZ, the manufacturer of tinted contact lenses, was determined to be out of conformance with the Quality System regulation because the firm failed to establish and maintain procedures for...

Device firm warned for failing to identify quality problems.(Human drugs)
July 1, 2007... Innovative Spinal Technologies, Mansfield, MA, the manufacturer of IST Pedicle Screw Systems and Paramount VBR Screw systems, was found to be out of conformance with GMPs and the Quality System regulation. For example, the firm was cited in...

Sitek receives warning letter for QA flaws.(Biologics)
July 1, 2007... The non-clinical laboratory Sitek Research Laboratories, Rockville, MD, was found to be out of conformance with Good Laboratory Practice (GLP) regulations regarding quality assurance responsibilities. In one study, the June 25 warning...