Validation Times articles from December 2003

Validation Times archives from December 2003

Some validation consultants say lax FDA enforcement part of poor performance by industry.(Software/computers)
December 1, 2003... PHILADELPHIA -- Despite much guidance from FDA and years of effort, the state of software and computer validation, at least in the drug industry, is still not good, and lax enforcement from FDA could be part of the problem. That was the...

Overly detailed SOPs and too many changes are red flags for FDA.(Change control)
December 1, 2003... PHILADELPHIA -- Companies can avoid 483s and warning letters if they evaluate their changes, validate them, and not have overly detailed SOPs for change control, according to industry consultants. "I have spent 20 years in the industry and...

'Reason codes,' annotations advised to help with Part 11 compliance.(Electronic records)
December 1, 2003... PHILADELPHIA -- Manufacturers considering changing their computer systems, whether to be Part 11 compliant or for other reasons, should consider systems that provide "reason codes" and should not fear making annotations during validation...

Software testing should reveal errors--not avoid them.(Software/computers)
December 1, 2003... PHILADELPHIA -- Computer and software validation should not rely on methods that seek to "avoid errors," but reveal them, two noted validation experts told the Barnett meeting here Dec. 4. Mats Bergkvist, president of SWE Enterprises,...

Configuration management more critical now, particularly for software; oversight board suggested.(Change control/software)
December 1, 2003... PHILADELPHIA -- Change control should be viewed as part of larger system of configuration management that monitors systems and equipment, particularly due to myriad software changes, speakers told CPT's Dec. 9 conference. Scott Hodges,...

Merck API plant nets 483 for lab control, data access issues under Part 11.(Human drugs)
December 1, 2003... FDA cited lab control system deficiencies, including data access (a key Part 11 issue) at Merck's active pharmaceutical ingredient (API) plant in Rahway, NJ, for which the firm received a three-item 483 following a fall 2002 audit by the New...

Pfizer central stability lab nets 5-item 483 for quality, lab controls.(Human drugs)
December 1, 2003... Pfizer's Central Stability Laboratory and Global Complaint Handling Unit, Morris Plains, NJ, received a 483 for quality system deficiencies including the firm's complaint-handling system, corrective actions and inadequate documentation. The...

Korean device firm cited for failing to validate sterilization, plus MDR issues.(Medical devices)
December 1, 2003... Korean dental implant manufacturer OSSTEM Implant Co., Ltd., was slammed with a 483 because it used an inappropriate sterilization validation process, lacked procedures for periodic cleanroom testing and monitoring, and also had no MDR...

Ligand lacks refiltration, shipping validation.(Blood & Biologics)
December 1, 2003... A "Team Biologics" inspection of Eli Lilly's Greenfield, IN, plant led to a 483 for San Diego-based Ligand Pharmaceuticals for failed integrity testing, lack of validation, failure to investigate assay failure and faulty shipping validation...

Bourget cited for not doing infectious-disease testing of tissue donor specimens.(Biologics)
December 1, 2003... During an Aug. 20-22 inspection of Bourget Health Services, Spokane, WA--a human organ and tissue testing facility--Seattle District investigators documented deviations of FDA rules regarding human tissue intended for transplantation,...

American Medical Devices lacks MDR, QC procedures.(Medical Devices)
December 1, 2003... Failure to establish procedures for the monitoring and control of process parameters for validated processes landed American Medical Devices, San Bernardino, CA, a warning letter, dated Nov. 24. According to the letter, FDA stated that the...

FDA objects to company's revised Process Validation Protocol.(Medical Devices)
December 1, 2003... A Sept. 16-30 inspection revealed that contact lens solution maker Applied Labs, Columbus, IN, was operating in violation of Quality System regulations and process validation for equipment, operations and installations qualifications--all...

American Mammographics lacks SOPs.(Medical Devices)
December 1, 2003... American Mammographics, Chattanooga, TN, received a warning letter Nov. 25 citing a lack of device master records and device history records. An FDA investigator, visiting the establishment Oct. 15-16, also noted there were no procedures for...

Agency says repackager failed to provide evidence or documentation of corrective actions following audit.(Medical Devices)
December 1, 2003... A July 8-14 inspection by Florida District Investigator Bill Tackett, Jr., at Ortho Technology's, Tampa, facility revealed sundry quality system violations for the repackager, relabeler and specification developer of various orthodontic...

Alternative therapy school's colonic irrigation systems lack 510(k).(Medical Devices)
December 1, 2003... Wood Hygienic Institute, Kissimmee, FL, an alternative therapy school that also distributes and manufactures colonic irrigation systems, received an Oct. 23 warning letter for its colonic irrigation systems, which Florida District investigators...