Validation Times articles from March 2009

Validation Times archives from March 2009

FDA pilot, new overseas office, ICH approach seen helping with security, but China overwhelmed.(Supply Chain Integrity)
March 1, 2009... ATHENS, GA -- FDA, acknowledging the increasing complexity of supply chains and that capacity will not allow for robust inspections of all ingredients, is placing greater emphasis on US manufacturers' role in ensuring integrity. The issue...

Continued verification of processes warrants trending, assessing data: Famulare.(Process Validation)
March 1, 2009... ATHENS, GA -- For continued process verification, manufacturers should trend/assess data and monitor and reference current GMPS--21 CFR 211.180-(e)--which states that data should be evaluated at least once annually, "... to determine the need...

Supply chain 'insufficient' with foreign goods, CDER compliance chief says; counterfeiting growing in Canada.(Imports/Supply Chain)
March 1, 2009... ATHENS, GA -- The United States must proactively address the challenges globalization has presented on imported drug products, according to speakers at the University of Georgia's 34th Annual International Good Manufacturing Practices...

China's FDA still overwhelmed by applications and plants to cover.(APIs)
March 1, 2009... ATHENS, GA -- In China, new government intervention and regulations have improved the manufacturing of ingredients and drug products over the past few years, said Weiping Li, head of regulatory affairs for Johnson & Johnson-China, who commented...

Software led 483 validation citations in '08.(Software Validation)
March 1, 2009... ATHENS, GA -- Process validation and, in particular, software validation, "continued to be among the more common 483 observations," Ronald F. Tetzlaff, Ph.D., corporate vice president of Parexel Consulting and a former FDA inspector, told the...

ICH Q10 implementation, incorporation into EU GMP Guide seen by summer 2010.(Inspections)
March 1, 2009... ATHENS, GA -- A working group of the International Conference on Harmonization (ICH) has composed a concept paper on the implementation of ICH Q10 and a proposal to incorporate Q10 as a new annex to the EU GMP Guide, which may appear as Annex...

Pascal cited for sterility, cleanliness and testing deficiencies.(Human Drugs)
March 1, 2009... Seventeen violations were recorded during a March 28-April 18, 2006, inspection of Bellevue, WA, drug manufacturing facility Pascal. FDA investigators Brenda Rohring and Terri Dodds, working with chemist Randy Self, observed that equipment...

Unigen warned for testing and record-keeping failures.(Human Drugs)
March 1, 2009... FDA investigator Brooke Seeman inspected Unigen Pharmaceuticals March 5-22, 2007, citing the company for 18 process deviations. The investigator found that the Westminster, MD, company had no method validation for several lots of eight...

GMP violations at Wallach.(Medical Devices)
March 1, 2009... FDA investigators Elizabeth Griffin and Anthony Onianawa issued a 10-item 483 following an inspection of Wallach Surgical Devices' Orange, CT, facility June 6-9, 2006. The FDAers faulted Wallach for failing to validate the function of its...

Process failures cited at Medtronic Neurological.(Medical Devices)
March 1, 2009... During a May and June 2006 inspection of Minneapolis, MN, Medtronic Neurological, FDA investigator Kellie Westerbuhr and Compliance Officer Timothy Phillips found that the company's design input work for its Model 8731 Intrathecal Catheter had...

Quality control lacking at Cyclotron Center of NE Florida.(Human Drugs)
March 1, 2009... Jan. 29--Florida District A July 31-Aug. 7 inspection of Cyclotron Center of NE Florida revealed substantial deviations from the United States Pharmacopoeia (USP) compounding standards and official monograph for Positron Emission...

Non-compliant manufacturing processes at Genzyme Corporation.(Human Drugs)
March 1, 2009... Feb. 27--New England District FDA investigators noted GMP violations in the production of licensed therapeutic drugs, bulk drug substances and drug components during an inspection of Cambridge, MA, Genzyme Corporation Sept. 15-Oct. 10. ...

FDA inspection discovers unapproved drugs at Prime Enterprises.(Human Drugs)
March 1, 2009... Jan. 29--Florida District Human and veterinary drug products and cosmetics manufacturer Prime Enterprises was found in violation of GMPs following a July 28-Aug. 1 inspection. FDAers documented repeat observations from a prior inspection...

Stability failures noted at Taro Pharmaceuticals U.S.A.(Human Drugs)
March 1, 2009... Feb. 5--CDER A July 28-31 inspection of Taro Pharmaceuticals, which manufactures non-sterile cream and ointment finished drug products, resulted in a warning letter to the Canadian firm, citing "multiple serious deficiencies" in GMPs. ...

CAPA procedures and GMP compliance cited at Alba Bioscience Limited.(Medical Devices)
March 1, 2009... Feb. 3--CBER During an Oct. 6-13 inspection, Alba Biosciences, which manufactures blood grouping reagents (BGR) that are classified as medical devices, FDA officials observed "a number of significant objectionable conditions relating to...

Documentation lacking at Medical & Clinical Consortium.(Medical Devices)
March 1, 2009... Feb. 2--Los Angeles District Drug and abuse test kit manufacturer Medical & Clinical Consortium was warned for its lack of conformity with GMPs following an inspection March 18-20, 25 and 31, 2008. The Industry, CA, agency's...