Validation Times articles from June 2006

Validation Times archives from June 2006

Inspectors to spend more time watching processes under new compliance program; parametric release CPG in offing, too.(Sterile drug inspections)
June 1, 2006... ARLINGTON, VA -- FDA inspections of sterile drug manufacturers will focus more on watching the manufacturing process, and a new compliance program guidance manual update is in the offing that will explain these new auditing procedures, a top...

Firms seeking to validate spreadsheets should eye 2 internal FDA guides.(Software validation)
June 1, 2006... Drug and device manufacturers seeking to validate spreadsheets for FDA-related purposes should examine two FDA bulletins for some guidance, a noted international expert in the area told a June 7 Expert Briefings.com audioconference. Ludwig...

483 citations for environmental monitoring down; not even in top 30.(Environmental monitoring)
June 1, 2006... ARLINGTON, VA -- The number of 483 citations involving environmental monitoring has dropped substantially in recent years, to the point where microbiological contamination problems and the like are not among the leading 483 problems, but an...

SAFE consortium seen clarifying digital signatures, new guide awaiting okay.(Electronic records/validation)
June 1, 2006... Computer validation, today, has many different guidelines for its many different niches. That will change when SAFE, a New York-based consortium of pharmaceutical companies, releases its computer validation best practices manual later this...

Experts disagree on allowing handicapped personnel in firms' clean rooms.(Gowning)
June 1, 2006... ARLINGTON, VA -- Experts in microbiological control disagreed on whether someone who is wheelchair-bound should be allowed to gown and work in a cleanroom. "My first thought was no, and then, Hell, No," said Russell Madsen, a consultant...

API manufacturer clears FDA inspection.(Human drugs)
June 1, 2006... A GMP establishment inspection of American Peptide, Vista, CA, netted no 483 for the company. Conducting the audit was investigator Linda Thai from the Vista, CA, District Office. The investigation covered quality, facilities and production...

Equipment contamination and poor quality audits highlight 18-item 483 to Bausch & Lomb; cleaning solution recalled.(Human drugs)
June 1, 2006... FDA May 16 released an 18-item 483 full of GMP violations at the conclusion of its seven-week inspection of Bausch & Lomb's Greenville, SC, plant where the firm manufactures its ReNu with MoistureLoc contact lens cleaning solution that was...

Electronic records and software validation cited in 21-item Carolina Liquid 483.(Medical devices)
June 1, 2006... Carolina Liquid Chemistries Corp., Brea, CA, was cited in a recent inspection due to software and electronic records not fulfilling the requirements of FDA's electronic records regulations (21 CFR Part 11). Also, the company was cited because...

Diazyme Labs 19-item 483 notes equipment calibration and maintenance flaws.(Medical Devices)
June 1, 2006... Failure to ensure that equipment was routinely calibrated and maintained netted a 19-item 483 for Diazyme Laboratories, General Atomics, based in San Diego, CA. The agency also issued a March 13 warning letter to the firm. Investigators Yvette...

Resonance Technology nets 7-item 483 for CAPAs, quality plans/procedures.(Medical devices)
June 1, 2006... Resonance Technology, Northridge, CA, received a seven-item 483 in a 2006 inspection because it failed to properly establish CAPAs [corrective and preventive actions]. Further, the device firm did not implement a quality plan or a quality...

Neil Labs written up for failure to establish appropriate specs.(Human drugs/dietary supplements)
June 1, 2006... During a Dec. 13-28, 2005, inspection of Neil Labs, East Windsor, NJ, an FDA investigator documented deviations from GMP rules, and also noted the firm was manufacturing a number of prescription drugs without approved applications. ...

Failure to investigate OOS nets letter for Wyeth.(Human drugs/dietary supplements)
June 1, 2006... FDA inspected Wyeth Pharmaceuticals' Guayama, PR-facility Nov. 7-Dec. 15, 2005, and determined the facility violated current GMP regulations in the manufacture, processing, packing and holding of the human drug products: Triphasil 21- and...

Quality Aspirators didn't implement/record method changes.(Medical devices)
June 1, 2006... Between March 29 and April 11, 2006, FDA conducted an inspection of Quality Aspirators, Duncanville, TX, which manufactures and distributes dental and surgical aspirators; loupes, with or without the clip-on headlights, suction valves and...

Failure to investigate nonconformities trips up Smiths Group.(Medical devices)
June 1, 2006... During an inspection of Smiths Group Plc's Hertshire-U.K. location Dec. 1-6, 2005, FDA determined the manufacturer of infusion pumps was not in conformance with current GMP requirements. Significant violations included failure to adequately...

Therics Spine comes up short in quality audits.(Medical devices)
June 1, 2006... During an inspection between March 3 and 16, of Therics Spine, Akron, OH, FDA determined the manufacturer of sterile, bone-void fillers was not in conformance with the QS Regulation for medical devices. First, the agency noted in the May 15...

Tri-State fails to validate processes.(Medical devices)
June 1, 2006... During an inspection of Tri-State Hospital Supply's facility located in Salisbury, NC, Jan. 18-26, an FDA investigator determined the reprocessor of various types of surgical stainless steel instruments--such as, scissors, forceps, hemostats...

Westone Labs lacks effective QS, QA.(Medical devices)
June 1, 2006... On March 24 and 29, an FDA Investigator conducted an inspection of Westone Labs, Colorado Springs, CO, and determined the manufacturer of custom-fit, hearing protection devices was in violation of current GMP requirements for medical devices....