Validation Times articles from February 2006

Validation Times archives from February 2006

ASTM E55 issues new draft of pharma standard, next ballot set for March.(PAT standards)
February 1, 2006... ARLINGTON, VA -- American Society for Testing Management's (ASTM) efforts to achieve standards for process analytical technology (PAT) for pharmaceutical and biological drug manufacturing reached a new milestone Feb. 21 when it issued a new...

10 firms piloting PAT, QbD, including 2 generics makers; March 2006 deadline imposed for participation.(CMC)
February 1, 2006... SAN FRANCISCO -- About 10 companies, including two manufacturers of generic drugs, are participating in the Center for Drugs CMC pilot program, whereby "quality by design" (QbD) is to be achieved by companies disclosing early developmental data...

'Critical path' conflict-of-interest requirements needed before FDA partners with outside world on PAT activities: CDER deputy.(Process analytical technology)
February 1, 2006... ARLINGTON, VA -- FDA will have to devise a conflict-of-interest staff manual guide under its new "Critical Path Initiative" before industry/agency collaboration over PAT proceeds, a top Center for Drugs official said here Feb. 21 CDER...

10 FTEs to be assigned to PADE inspections in FY '06: CDER official.(Post-marketing surveillance)
February 1, 2006... WASHINGTON -- Field inspection staffing for the monitoring of post-marketing adverse drug experiences (PADEs) is on the upswing, with 10 full-time equated employees (FTEs) slated for assignment in fiscal year 2006, compared to just one in FY...

Avid Bioservices advised to use qualified, validated equipment; Part 11 also mentioned.(Human drugs)
February 1, 2006... No 483 was issued in a recent GMP establishment inspection to Avid Bioservices, a mammalian cell culture contract manufacturing facility in Tustin, CA. However, Investigators Virgilio Pacio and Donna Besone from FDA's Irvine, CA, District...

Schering-Plough gets 6-item 483 for water system sanitization and maintenance.(Human drugs)
February 1, 2006... Schering-Plough HealthCare Products, Cleveland, TN, was slapped with a six-item 483 because firm records showed that sanitization and maintenance operational checks conducted on its purified water system were inconsistent. New Orleans...

FDA continues to cite Part 11 violations in 483 for Takeda.(Human drugs)
February 1, 2006... The requirements of 21 CFR Part 11 were not met in the computerized and paper systems used in the recording of quality control testing data, resulting in a seven-item 483 for Takeda Chemical Industries, Hikari, Yamaguchi, Japan. The...

Guidant cited for Part 11 issues in 15-item 483; J&J merger postponed.(Medical devices)
February 1, 2006... A recent inspection of Guidant Corp. found that the device manufacturer was deficient in the areas of software validation, electronic records and Part 11 compliance, netting a 15-item 483. Guidant's merger with Johnson&Johnson was put off...

National Genetics Institute cited for software validation flaws.(Blood/biologics)
February 1, 2006... During an Aug 22-Sept. 1, 2005, inspection of the National Genetics Institute (NGI)--which manufactures HIV-1 nucleic acid tests (NATs) and hepatitis C virus (HCV) NATs, and performs donor testing using those tests on donor samples received...

Boston Scientific hit with warning letter for three separate facilities.(Medical devices)
February 1, 2006... FDA performed inspections of Boston Scientific Corp. (BSC) at three separate facilities: Natick, MA, July 27-Aug. 26, 2005; Maple Grove, MN, July 22 Aug. 25, 2005; and Spencer, IN, Aug. 25-Sept. 12, 2005, and found serious quality control...

Quality audits and validation of sterilized products lacking for Haemacure.(Medical devices)
February 1, 2006... During a Nov. 28-29, 2005, inspection, FDA concluded that Haemacure Corp., Sarasota, FL, was not in conformance with the current GMP requirements of the QS regulation. Essentially, in the Jan. 5 warning letter, the investigator noted that...

Gambro Dasco SpA cited for CAPAs.(Medical devices)
February 1, 2006... A Sept. 19-29, 2005, investigation of Gambro Dasco SPA, Medolla, Italy, determined the manufacturer of electromechanical dialysis control systems for standard and critical care was not in conformance with the current GNP requirements of the QS...