Validation Times articles from April 2002

Validation Times archives from April 2002

Firms should move to process analytical technology, top CDER official says.(Center for Drug Evaluation and Research's Jane Axelrad)(Brief Article)
April 1, 2002... Industry might harbor concerns regarding the use of process analytical technology (PAT), but Center for Drugs officials hope drug manufacturers will start to embrace PAT now, a top CDER official said. Jane Axelrad, associate director for...

Use of common equipment in tissue-based products concerns FDA; cellular, tissue rules designed to be risk-based.(Food and Drug Administration. Center for Biologics)(Brief Article)
April 1, 2002... VIENNA, VA - FDA's Center for Biologics is concerned about manufacturers using common equipment for tissue-derived products with therapeutics not derived from tissue due to the potential for transmissible spongiform encephalopathies (TSEs). ...

Organization of data rates high with FDA, along with security.(Food and Drug Administration recommends strict records management)(Brief Article)
April 1, 2002... Philadelphia Correspondent PHILADELPHIA - It's not only good enough to have a computer system in manufacturing that is secure, but where the records are organized so FDA can rely on the data, a noted consultant on electronic signature/records...

Scope, intensity of investigations should be dictated by type, source of adverse information.(investigating good manufacturing practice)(Brief Article)
April 1, 2002... VIENNA, VA - The question of when to launch an internal GMP investigation is raised frequently, Clearant Senior Vice President of Regulatory and Quality Issues Thomas Lynch, Ph.D. told IBC here: "The rote answer is 'always.' I would suggest an...

FDA may rewrite compounding rules 'from scratch'.(Brief Article)
April 1, 2002... FDA might have to "start rewriting from scratch" its regulations on pharmacy compounding, although the agency is appealing to the U.S. Supreme Court a February 2001 federal appeals court decision that struck down its power to regulate the...

Summary points regarding GMP investigations.(Brief Article)
April 1, 2002... from materials by Thomas Lynch, Clearant * Establish criteria for initiating GMP investigations at different levels of effort. * Integrate disciplines needed for meaningful investigation and evaluation. * Focus scope on relevant...

Virus filter validation testing on bacteriophages O.K., despite FDA guidance: Pall exec.(Brief Article)
April 1, 2002... New York/New Jersey Correspondent NEW YORK - FDA recognizes that a virus filter user can get comparable performance evaluation results by testing the filter with bacteriophages (viruses of bacteria) rather than mammalian viruses, a top Pall...

Not all equipment can be validated as Part 11 'compliant'; distinguishing critical/non-critical data important.(Brief Article)
April 1, 2002... New York/New Jersey Correspondent NEW YORK - Manufacturers should distinguish between "critical" and "non-critical" data to show FDA inspectors and should not expect all equipment - such as high-speed capsule fillers - as being "Part 11...

JOAMCA cleaning, installation validation doesn't wash with FDA.(JOAMCA Chemical Products, Food and Drug Administration).(Brief Article)
April 1, 2002... New Orleans district investigator Marvin Jones identified processing equipment validation deficiencies during an October 2001 inspection of the Madison, MS-based hand soap manufacturer JOAMCA Chemical Products. The 483 cited the firm for...

Veterinary drug maker Phoenix held to human drug GMPs.(Phoenix Scientific)(Brief Article)
April 1, 2002... Confusion over what detergent was used to clean production equipment for Phoenix Scientific's Sulfadimethoxine Soluble Powder accounted for one of the 22 findings uncovered by FDA inspectors during a two-month inspection the firm's St. Joseph,...

Holox hit for unvalidated USP assays, GC suitability.(Brief Article)
April 1, 2002... An April 2000 inspection of Fairburn, GA-based medical gas manufacturer Holox revealed the firm's failure to validate and maintain written procedures on analytical methods used to test several of their products. Investigators Penny...

Merck's West Point 483 replete with aseptic deficiencies.(Brief Article)
April 1, 2002... FDA's inspection of records at Merck & Company's West Point, PA, facility found that at least one Merck employee performed aseptic operations 47 days prior to completing "aseptic skills/gowning" training and seven days before records indicated...

Six of 30 Cumberland Swan GMP violations date back two years: FDA.(Brief Article)
April 1, 2002... Six GMP violations including cleaning validation remained unresolved from a late 1999/early 2000 FDA audit of Cumberland Swan's Smyrna, TN, facility according to a just-released Feb. 11, 2002, warning letter. The violations were found to...

GOJO hopes to clean up remaining validation deficiencies by 2003.(Brief Article)
April 1, 2002... Deficiencies in formula validation procedures for OTC topicals Purell and Hand Medic III manufactured by GOJO Industries should be corrected by the end of the year, according to GOJO Chief Operating Officer Mark Lerner in an April 9 interview....

Undocumented design change could have Dayton in hot water.(Dayton Water Systems)(Brief Article)
April 1, 2002... Verification and validation of design changes to a hemodialysis water treatment system manufactured by Dayton Water Systems were not documented, according to a March 14 warning letter issued by FDA's Cincinnati district. A two-week...

Tyco told to reign in questionable sterility validation at Radionics.(Brief Article)
April 1, 2002... Failure to validate packaging and sterilization processes by Burlington, MA-based Radionics on its line of cerebrospinal fluid (CS]a) shunts and catheters has FDA concerned over the sincerity of its other 510(k) commitments. In a Oct....

Lax calibration, MDR of chiropractic table pinned on Sweat.(Brief Article)
April 1, 2002... A December 2001-January 2002 inspection of the Sweat Chiropractic Clinic, Atlanta, by Atlanta District Office investigator Patricia Hudson revealed that, as specifications developer and quality assurance agent for the Atlas orthogonal adjusting...