Validation Times articles from September 2007

Validation Times archives from September 2007

With recalls numbering 975 to date, FDA relying on ICH Q10 for QbD progress.(Quality-by-design/recalls)
September 1, 2007... WASHINGTON -- Despite FDA efforts towards better control of the pharmaceutical quality system through quality-by-design (QbD), as of Sept. 17, there were 14 Class I, 858 Class II and 103 Class II recalls, for a total of 975 for the 2007 fiscal...

7 CMC guidance documents withdrawn for non-conformity with FDA's GMP initiative.(CMC)
September 1, 2007... WASHINGTON -- FDA is withdrawing seven guidance documents for chemistry, manufacturing and controls (CMC), which were drafted before the 2001 Pharmaceutical GMPs for the 21st Century Initiative because they are "not in line with our current...

GMP audit imminent after 6-year inspection gap, states 2007 risk-based model: Gardner.(Inspections)
September 1, 2007... WASHINGTON -- As the agency transitions more to risk based models to increase regulatory scrutiny depending upon public health risk, FDA's most recent GMP inspection model determines that after six years of no inspections, the site must be...

Risk-based auditing nets 6% decrease in follow up FDA audits in same year.(Risk-based inspections)
September 1, 2007... WASHINGTON -- The application of FDA's risk-based inspection process has resulted in a 6% decrease in the number of sites being reinspected in the same fiscal year, according to comparisons between fiscal year 2000 and 2005, reported a senior...

IPEC group examining applying principles of validation to non-actives.(Excipients)
September 1, 2007... ALEXANDRIA, VA--Excipient makers are debating whether to apply validation principles to their products, as the European Union and individual members continue to discuss extending GMPs to all excipients, especially in light of events--mostly in...

Dirty equipment and CAPAs net 4-item 483.(Human drugs)
September 1, 2007... DanChem Technologies, Danville, VA, netted a four-item 483 because its equipment cleaning procedures did not assure the removal of certain fibers following tears of the screen in the centrifuge, according to FDA records. Corrective and...

Improper laboratory controls, validation net 483 for Ivax.(Human drugs)
September 1, 2007... Ivax Pharmaceuticals, Cidra, P.R., was hit with a three-item 483 because its laboratory controls did not include the establishment of scientifically sound and appropriate specifications and test procedures. Investigator Rebecca Parrilla...

Dornier Medtech cited for undocumented process validation.(Medical devices)
September 1, 2007... Dornier Medtech America, Kennesaw, GA, received a six-item 483 because because process validation activities and results were not documented. Inspector Patricia Hudson from the Atlanta, GA, District Office wrote the report. Only the 483...

Medical concepts gets 9-item 483 for CAPAs, unvalidated lab tests.(Medical devices)
September 1, 2007... Medical Concepts Development, Woodbury, MN, received a nine-item 483 that cited the device firm for inadequate CAPA procedures and test results being improperly validated. A Feb. 2 warning letter also was issued. Investigator Jocelyn...

Tmed nets 5-item 483 for CAPAs.(Medical devices)
September 1, 2007... Tmed, Columbia, TN, received a five-item 483 because of inadequate CAPA procedures. Investigator Cheryl Scott conducted the audit on behalf of FDA's Nashville, TN, District Office. Regarding CAPAs, the report stated that these...

Method validation documentation cited in Kushan letter.(Human drugs)
September 1, 2007... FDA reviewed the Kunshan Chemical and Pharmaceutical, Jisngsu, China, ingredient facilities in April 2007 and revealed several GMP violations in the manufacture of active pharmaceutical ingredients (API). The Sept. 6 warning letter listed...

Leiner Health issued letter regarding data manipulation.(Human drugs)
September 1, 2007... FDA conducted an inspection Jan. 22-Mar. 16, 2007 at the manufacturing facility of Leiner Health Products, Carson, CA, and found the company out of GMP compliance in the manufacturing of some of its drug products. The Aug. 28 warning...

Danmar receives warning letter for CAPAs.(Medical devices)
September 1, 2007... FDA conducted an inspection June 1-14, of Danmar Products, Ann Arbor, MI, and found that the methods used in or the facilities or controls used for, the manufacture, packing storage, or installation of the company's devices, Michigan Cranial...

Management not monitoring quality system cited for North Coast.(Medical devices)
September 1, 2007... During an inspection, April 6-24 at North Coast Medical facilities in Morgan Hill, CA, it was determined that the methods used in, or the facilities or, controls used for the manufacturing, packing, storage, or installation of the company's...

Device firm written up for CAPAs, quality system procedures.(Medical devices)
September 1, 2007... During an inspection completed June 18-19 at Potty MD, Knoxville, TN, it was found that the methods used in, or the facilities or controls used for the manufacturing, packing, storage or installation of the company's enuresis (bed-wetting)...