Validation Times articles from May 2003

Validation Times archives from May 2003

Legacy systems 'changed' no longer have 'legacy' status; final Part 11 guide forthcoming. (Electronic records).
May 1, 2003... PHILADELPHIA--Changing a legacy computer system likely would render it a new system and thus subject to greater enforcement oversight by FDA under the agency's electronic signature/records regulation (21 CFR Part 11), a Center for Devices...

FDA to reward industry 'champions' implementing PAT with lower risk assignment. (Process analytical technology).
May 1, 2003... GAITHERSBURG, MD--Companies that voluntarily adopt Process Analytical Technology (PAT) could be rewarded by FDA with a "low risk" designation, meaning under the new risk-based "Pharmaceutical GMPs for the 21st Century Initiative" they could...

Development reports still a stumbling block in GMP Initiative. (CMC).
May 1, 2003... The concept of manufacturers submitting development reports so the agency can get a better idea how products are developed and made is a major obstacle in the agency's new GMP Initiative. Development reports remain a point of contention for...

Immunogenicity: how to regulate; how to test? (Analytical methods).
May 1, 2003... BETHESDA, MD--FDA provided insight into how it will apply its risk-based approach to immunogenicity testing for biological therapeutics and how novel products in development, as well as changes in manufacturing for licensed products, will be...

Systems validation, security needs not dead, though some firms think so. (Electronic records).
May 1, 2003... PHILADELPHIA -- When it comes to FDA's full-circle approach to Part 11, consultant John McKenney says: "People in industry keep saying, 'We don't need to validate anymore,' when that is definitely a myth." McKenney, who is president of SEC...

Cleaning validation missing evaluation of detergent residuals at Barr, change control, water system also need work. (Human drugs).
May 1, 2003... Blender problems netted Bart Laboratories a 483 in 2001 but quick action in a 2002 follow-up inspection allowed the generic drug maker to head off a second 483. According to the EIR, written up by New Jersey District investigator Nancy...

Duramed challenged by impurities, discontinued product in re-inspection. (Human drugs).
May 1, 2003... Validation of a dissolution test and tablet friability issues ended up dogging Duramed Pharmaceuticals over a year due to the watchful eye of New Jersey investigator Joy Kozlowski-Klena. The Somerset, NJ-based company received a 15-item 483...

Inadequate cleaning and packaging validation raise concerns at Sharp. (Human drugs).
May 1, 2003... Sharp, a contract packager headquartered in Conshohocken, PA, received a six-item 483 following a June 2002 audit due to inadequate maintenance of packaging equipment when FDA discovered an internal report of "black particles" in an...

Ethicon attributes holes in balloon to suppliers, customers, but gets 483. (Medical devices).
May 1, 2003... Although Johnson & Johnson division Ethicon aced the verification of corrective actions following a recall, the firm was still hit with a single-item 483 for another device in its product line. New Jersey District investigators IGnh Quoc...

Software changes need validation in DMR, plasma association finds. (Blood & Biologics).
May 1, 2003... The American Blood Resources Assn. (ABRA) learned the hard way that it is responsible for validating changes of a host server's proprietary referral software into its own Device Master Record (DMR) regarding the group's National Donor Deferral...

No complaint handling adulterates surgical lights. (Medical Devices).
May 1, 2003... The lack of a complaint-handling unit netted Designs For Vision, Inc. a warning letter April 9, according to FDA documents. FDA stated the Ronkokoma, NY-based firm's DayLite XeNon Light Source surgical light was adulterated because the firm...

Pulmonetic ECOs were not validated, letter claims. (Medical Devices).
May 1, 2003... Not validating engineering change orders (ECO) landed Pulmonetic Systems, Inc. in hot water with FDA, according to a warning letter recently released by the agency. Concerning the Minneapolis, MN-based firm's LTV Series ventilators, the...

Bugs in blood bank software not widely reported to users. (Blood & Biologics).
May 1, 2003... FDA hit French firm MAK-System S.A. International Group with failed to verify and validate the corrective and preventive actions (CAPA) to its Progresa Soundex blood bank software. The agency also stated the firm failed to establish...