Validation Times articles from January 2002

Validation Times archives from January 2002

Nothing new in final guidance, but key clarifications could aid compliance efforts.(software validation guidelines from Food and Drug Administration's Center for Devices)
January 1, 2002... FDA's Center for Devices Jan. 11 at last released its final software validation guidelines and, despite requests from industry, it has opted not to recommend specific validation methods. In all, there is little in the way of new information...

PhRMA opposes user fees for further FDA enforcement, says talks stalled by lack of commissioner.(Pharmaceutical Research and Manufacturers of America)(Brief Article)
January 1, 2002... The leading trade group for prescription drug manufacturers would like to see the Prescription Drug User Fee Act (PDUFA) renewed as-is this year with no further funds for enforcement or post-marketing surveillance, as FDA wants. Addressing...

Acceptance criteria, nature of contaminant, residue key in master plans.
January 1, 2002... PHILADELPHIA - FDA wants to see acceptance criteria built into the master plan for cleaning validation, but companies must first determine the nature of the contaminants and other inputs, industry executives advised at a Barnett/Parexel...

Protocols a work in progress.(excepts of a speech given by Steven Ostrove, Ph.D., president of Ostrove Associates)
January 1, 2002... PHILADELPHIA - Developing and executing written cleaning process and cleaning validation protocols that will meet the requirements of FDA, Canada, Japan and the European Union (EU) are still a work in progress, according to Steven Ostrove,...

Use matrix system to assure reproducible results.(Ruey-Ching Hwang creates system for cleaning processes and validation)(Brief Article)
January 1, 2002... PHILADELPHIA - A coin-toss test illustrated the statistical possibility of apparent success even when the science does not support it in Ruey-ching (Richard) Hwang's presentation at a Barnett/Parexel meeting here. Hwang, whose Ph.D is in...

How to deal with cleaning and contract manufacturers.(excepts of speech given by Ann Johnson, senior cleaning validation specialist, Diosynth RTP.)(Brief Article)
January 1, 2002... PHILADELPHIA -For the fast change artist, working on the cleaning validation team in a contract manufacturing company is the ideal job. In the research and development business, "each day saved from start to market can save the company $1.4...

Fewer methods for cleaning, sampling advised.(excepts of speech given by Steve Weitzel, director of process validation for Novaflux Technologies)
January 1, 2002... PHILADELPHIA - Sometimes simpler is better when it comes to cleaning validation, an executive at Novaflux Technologies told Barnett's conference here. Addressing the Jan. 14 session, Steve Weitzel, director of process validation for the...

OTC maker lacks staff, equipment for assays, and microbiological tests.(Brief Article)
January 1, 2002... Unique Labs of Chatsworth, GA, ran into considerable trouble for product labels for several of its skin barrier products, but validation issues dogged the firm as well in an October 2000 inspection by Atlanta district investigator Vicky...

ESD, environmental monitoring noted in Datrend audit.(FDA inspects Datrend Systems for not monitoring electrostatic discharges)(Brief Article)
January 1, 2002... FDA's inspection of Canada's Datrend Systems of Delta, British Columbia, reinforced the agency's position that high ambient humidity is no cover for lack of environmental monitoring procedures for electrostatic discharges (ESD). The maker...

Purchase of unvalidated product line brings warning, caution re: family validation.(Meridian Diagnostics received warning letter from Food and Drug Administration)(Brief Article)
January 1, 2002... In vitro diagnostic maker Meridian Diagnostics of Cincinnati, OH, found it had purchased validation problems when it bought Gull Labs of Salt Lake City, UT, in 1998. According to FDA records, Gull had not completed validation work on some...

Equipment QC, calibration, backbones for blood bank citations.(Brief Article)
January 1, 2002... Aultman Health Foundation of Canton, OH, netted a 13-item 483 after Cincinnati district investigator Nancy Neige's June 2001 inspection, including a finding that the unlicensed blood bank performed quality control on a two-speed centrifuge for...

Warning Letter Analysis.
January 1, 2002... Details of key FDA warning letters released the weeks of Dec. 3, 10, 17, 24, 31, 2001 and Jan. 7, 2002 that contain citations for validation. Each letter is $7 plus retrieval.

FDA says no to visual exam for particulates; Purdue recalls 388 lots of oxycontin.(Food and Drug Administration, Purdue Pharma)(Brief Article)
January 1, 2002... Purdue Pharma endured two inspections of its plant in Totowa, NJ, in 2001 and, not surprisingly, got a Nov. 9 warning letter, including a citation for failing to keep stearyl alcohol tainted with black particulates from being used in...

COA no substitute for reviewing OOS outcomes.(Accumed receives warning letter from FDA, certificate of analysis for out-of-specification outcomes)(Brief Article)
January 1, 2002... FDA's Sept. 19-28, 2001, inspection of Accumed of Lawrenceville, NJ, netted the firm a Nov. 9 warning letter that cited the company for failure to follow a procedure for out-of-specification investigations for three OOS events. One of these...

Soap maker flummoxed by FDA regulations.(JOAMCA Chemical Products)(Brief Article)
January 1, 2002... The Nov. 13, 2001, warning letter to JOAMCA Chemical Products, Madison, MS, led with a citation for failure to establish a quality control unit, but also stated the maker of OTC drugs and cosmetics did not validate cleaning procedures for...

Warning hints at lack of familiarity with GMPs at Gar.(Brief Article)
January 1, 2002... Gar Labs of Riverside, CA, received a Nov. 20, 2001, warning letter for a variety of GMP lapses, including failure to validate a reverse osmosis water system for its production of OTC drug products. FDA noted in closing that the firm was...

Mixing procedures a hangup for OTC maker.(Brief Article)
January 1, 2002... Drug and dietary supplement maker Natural Technology of Terrell, TX, landed a Dec. 14, 2001, warning letter that claimed the firm had "no manufacturing process validation for drug products and the associated equipment utilized in drug...

Metal fragments tied to equipment set-up, spur warning.(Brief Article)
January 1, 2002... CFH Labs, Morris Plains, NJ, received a Nov. 13, 2001, warning letter citing its alleged failure to investigate the cause of a nonconformity involving metal contamination in the firm's production of three lots of enzymatic tablets, a contact...

Korean firm makes too much to qualify under ISO small-volume standard.(Brief Article)
January 1, 2002... Osstem Implants of Bustan, Korea, took in a Nov. 30, 2001, warning letter with a citation covering sterilization of small-volume production of dental implants. According to FDA, Osstem's production exceeded the ISO/TR 13409 limit of less than...

FDA hits Genzyme unit for cross-validation.(Brief Article)
January 1, 2002... Genzyme Biosurgery, a subsidiary of Genzyme of Cambridge, MA, hosted an unnamed investigator from the New Jersey district in September and October 2001 and earned a Nov. 8 warning letter with a citation for a less-than-exhaustive validation...

Reprocessors still under FDA's microscope.(Brief Article)
January 1, 2002... Investigator Ricki Chase-Off's June 11-15 inspection of reprocessor Medical Device Services, St. George, UT, showed FDA is still looking for traditional GMP systems for this industry. The Dec. 13 warning letter cited MDS for failure to validate...

Utah Medical gets Part 11 validation advice in warning letter.(Brief Article)
January 1, 2002... Investigator Thai Duongs's review of the Midvale, UT, plant operated by Utah Medical Products of St. George, UT, resulted in a warning letter citing failure to validate an unnamed process for the Intran Plus line of products, noting a number of...

3 veterinary drug makers hear another "V" word.(Brief Article)
January 1, 2002... At least three veterinary drug manufacturers have been cited for validation lapses since late November. A Nov. 27 warning letter to Custom Manufacturing, Medley, FL, cited failure to validate drug manufacturing processes including a...