Validation Times articles from October 2007

Validation Times archives from October 2007

GMP audits in India nearly double in FY '07, but inspections in China drop, CDER chief notes.(Inspections)
October 1, 2007... BETHESDA, MD -- The trend is toward increased GMP inspections in India, with 62 occurring in FY 2007, compared to 34 in FY '06 and 33 in FY'05, FDA officials told the annual Generic Pharmaceutical Assn. (GPhA) technical conference here. ...

Sterility assurance submission must be well organized, FDAer says.(Sterility)
October 1, 2007... BETHESDA, MD -- To optimize sterility assurance submissions, remember to clearly identify terminal sterilization and aseptic processing in the submission cover letter or executive summary, and remember to provide a detailed sterility assurance...

Clear and complete QOS yields shorter reviewer time.(CMC)
October 1, 2007... BETHESDA, MD -- A QOS (quality overall summary)--part of the CID format that provides a summary of CMC aspects of a drug application--that "clearly and completely addresses all the questions in the QbR [quality-based review] should result in...

CTD electronic format recommended for ANDAs to support QBR.(Question-based review)
October 1, 2007... BETHESDA, MD -- FDA strongly recommends that generic drug firms submit all ANDAs in the International Conference on Harmonization (ICH) Common Technical Document (CTD) format, preferably in electronic form, to support QbR, and would like to...

'Tell regulatory everything,' consultants advise RAPS.(Inspections)
October 1, 2007... BOSTON -- Relationships might not seem to have much to do with science, but they have a great deal to do with doing science effectively. That was the message given by David Furr of FDC Services, Karen Jones of Millennium Pharmaceuticals,...

QS urged to prevent DEG contamination in drug products.
October 1, 2007... BETHESDA, MD -- A quality systems approach along with following some standard analytical tests can go a long way to detect and weed out diethylene glycol (DEG) in drug products, notably OTC cough syrups, CDER Compliance Director Deborah Autor...

ChemAgis nets 2-item 483 for tardy stability sampling.(Human drugs)
October 1, 2007... ChemAgis, Raurat-Hovav, Israel, netted a two-item 483 because the pharmaceutical manufacturer failed to conduct stability sampling on a timely basis. Conducting the audit for FDA's Center for Drugs were investigators Margaret Annes and...

Parkedale passes pre-approval inspection; validation, media fill time issues noted.
October 1, 2007... Parkedale Pharmaceuticals, Rochester, MI, was not cited in a GNP pre-approval inspection, although minor verbal observations were noted regarding validation, media fill hold times and sterility testing practices. The audit of this wholly...

Dialysis Services cited for design procedures, CAPAs, validating device design.(Medical devices)
October 1, 2007... Dialysis Services, Springfield, TN, was slapped with a six-item 483 because procedures for verifying design output meets design input were not established. Investigator Travis Chapman from the Nashville, TN, District Office conducted the...

Multiple GMP violations noted in Genzyme letter.(Blood/biologicals)
October 1, 2007... FDA conducted an inspection of Genzyme between June 6 and June 19 and unearthed GMP deviations in the manufacture of Thymoglobulin Formulated Bulk lots (bulk lots). According to the Sept. 19 warning letter, FDA described a number of...

Chiu Technical warned for CAPAs.(Medical devices)
October 1, 2007... During an inspection of Chin Technical between April 19 and May 1 FDA determined the manufacturing of The Transilluminator, Model BFO-150, was is in violation of Quality Systems/GMP regulations, including failure to establish and maintain QS...

Quality policy flaws, software validation, noted for Dialysis Dimensions.
October 1, 2007... FDA conducted an inspection May 2-3, 7-9, 15 and 17 at the facilities of Dialysis Dimensions, Nashville, TN, and found GNP violations in the manufacture ring of BiCarb Mixing System, the AquaDuct Fluid Delivery Networks and the Water Vault...

CAPAs and calibration net letter for Healthway.
October 1, 2007... During an inspection of Healthway Home Products, Pulaski, NY, May 4-11, FDA found an array of GNP violations involving Filtration Systems Portable Room Air Cleaners, including calibration and CAPAs, according to the warning letter. For...

CAPA flaws, process control net letter for device company.
October 1, 2007... During an inspection of SCM True Air Technologies, Louisville, KY, on Aug. 16 and 17, FDA determined the methods used in, or the facilities or controls used for manufacturing, packing, storage, or installation of the firm's alternating pressure...

Zinnanti Surgical cited for validation problems.
October 1, 2007... FDA conducted an inspection of Zinnanti Surgical Design (ZSD), Hershey, PA, on July 17-26, 2006; Nov. 8-15, 2006, and Mar. 28-29, 2007, and found a variety of validation-related problems involving the Bayonet Electro-Surgical Pencil (BESP)...