Validation Times articles from May 2004

Validation Times archives from May 2004

'Critical quality attributes' must be defined before using PAT for biotech, FDAer says.(Process analytical technology)
May 1, 2004... BOSTON -- FDA is pushing hard for molecular-entity drug makers to adopt process analytical technology (PAT) in order to bring their manufacturing and QC into the 21st century, but biotech companies may have to focus on potential critical...

FDA going to greater lengths in overseeing lyophilization, expert says.(Manufacturing)
May 1, 2004... PHILADELPHIA -- FDA inspectors appear to be paying closer attention to lyophilization in pharmaceutical plants, an expert said here May 13. "We're seeing a lot of development in the area of lyophilization--a lot more interest from the...

Maryland GMP facility to offer training to FDA inspectors, industry.(Training)
May 1, 2004... WASHINGTON -- The University of Maryland Biotechnology Institute (UMBI), Baltimore, plans to open a 15,000-square-foot pilot biotech facility in August 2004, for use in training FDA inspectors and industry personnel. Addressing the annual...

Companies go beyond quality systems to quality culture.(Quality systems)
May 1, 2004... PHILADELPHIA -- Simply having a quality system may not be enough; companies are currently being urged to adopt a cross-departmental quality culture. At an FDANews Quality Systems conference here May 5, experts discussed how to institute quality...

PAT not seen as panacea for quality systems, may require 'constant human analysis,' Biogen exec says.(Quality systems)
May 1, 2004... PHILADELPHIA -- Industry is steadily embracing process analytic technology but is its ability to monitor manufacturing a boon or a burden to quality systems? Michael Kowolenko, senior vice president of global quality at Biogen IDEC in...

OTC manufacturer changes product specs following validation.(Human drugs)
May 1, 2004... Validation deficiencies, out-of-specification (OOS) test results and failure to investigate were among quality system deficiencies that netted OTC pharmaceutical manufacturer Pharmaceutical Formulations Inc. (PFI) a nine-item 483 following a...

Steris cited for validation testing, failure to report a removal to FDA.(Medical devices)
May 1, 2004... FDA cited Steris Corp. in an eight-item 483 for validation testing deficiencies, failing to report a correction/removal to FDA and not justifying in writing why a field notification was not handled as a removal. FDA's Cincinnati District...

Drug maker cited for using municipal water, not validating 'pasteurization'.(Human Drugs)
May 1, 2004... Drug manufacturer Consolidated Chemical, St. Louis, was cited in a March 23 warning letter for using municipal water instead of purified water USP to clean manufacturing equipment and filling lines as well as failing to validate a...

Firm cited for failure to do 'root cause analysis' with software.(Medical devices)
May 1, 2004... MedRx, Inc., Largo, FL, was cited in a March 1 warning letter for various medical device Quality System (QS) problems, including numerous software and hardware failures for which the problems appeared to be unresolved, and for which no root...

Failure to revalidate manufacturing, sterilization yields warning to Abbott HPD, now, 'Hospira'.
May 1, 2004... Abbott's Hospital Products Division in Lake Forest, IL, which was spun off April 30 into a new firm, Hospira, received a March 25 warning letter, primarily because of sterilization and validation faults related to its Lifeshield Latex-Free and...