Validation Times articles from November 2007

Validation Times archives from November 2007

USP moves toward a universal standard for Protein A.(Well-characterized biologicals)
November 1, 2007... RESTON, VA -- Protein A, used in the purification of most monoclonal antibodies, does not currently have a universal standard, but USP is striving to provide "a standard to aid in an accurate determination of the amount of residual Protein A,"...

Maximize the value of your cleaning validation program through holistic project management.(Guest column--cleaning validation)
November 1, 2007... In a world where information overload is all too common, it is easy to succumb to the temptation to narrow one's focus, ignoring anything that seems extraneous. This attitude is often reinforced by certain organizational structures that do not...

Many methods of protein aggregation used together make complete picture.(Proteins)
November 1, 2007... RESTON, VA -- Aggregation--a common degradation pathway for protein pharmaceuticals--can be accomplished in several ways that should be used together to create a total picture: size exclusion chromatography, SDS-PAGE, capillary gel...

Nature/history of production cell line key to justify virus detection assay omissions.(Assays)
November 1, 2007... RESTON, VA -- A number of general factors should be considered in justifying the omission of any of the virus detection assays listed in ICH Q5A and a reduction of product specific validation studies, noted Hannelore Willkommen, Ph.D.,...

Recommendations made to drug compounder, no 483 given.(Human drugs)
November 1, 2007... Hal's Compounding Pharmacy, San Diego, CA, was the target of a recent inspection due to a complaint that was received about the firm allegedly producing "large quantities of non-patient specific compounded products and shipping them...

Process design controls, incomplete validation trip up AmeriWater.(Medical devices)
November 1, 2007... AmeriWater, Dayton, OH, received an 18-item 483 following a recent GMP inspection because procedures to control the design process of the device were not implemented, as well as incomplete validation of the chemical feed system. ...

CAPAs and risk analysis flaws net 8-item write up.(Medical devices)
November 1, 2007... Medtronic Neurological, Minneapolis, MN, received an eight-item 483 following a recent audit for incomplete risk analysis and failure to implement CAPA procedures. Also issued was a July 3, 2007, warning letter. Conducting the audit for...

Cytosol Labs slighted for calibration flaws.(Human drugs)
November 1, 2007... During an inspection of Cytosol Laboratories, Braintree, MA, May 23-June 20, FDA documented significant deviations from GMP practice in the manufacture of the company's human drug products, Anticoagulant Citrate Phosphate Dextrose Adenine...

Validation flaws and failure to test to conformance noted in warning letter.(Human drugs)(Medical condition overview)
November 1, 2007... FDA conducted an investigation Dec. 20-21, 2006 at the facilities of Med-South Pharmacy dba Partners In Care, Orange Beach, AL. The inspection was initiated in response to reports of injuries relating to betamethasone acetate/betamethasone...

Northeast General Pharma warned for API contamination problems.(Human drugs)
November 1, 2007... FDA completed a review Aug. 27-30 for the inspections conducted at the facility of Northeast General Pharmaceutical Factory, Liaoning, China, and determined the manufacture of the firm's active pharmaceutical ingredients (API) was in violation...

PlasmaCare warned for CAPAs and temperature alarms.(Blood/biologics)
November 1, 2007... An FDA inspection conducted Aug. 8-17 at the plasma collection facility of PlasmaCare, Cincinnati, OH, revealed several violations, including, but not limited to a failure to maintain written SOPs for the collection, processing, testing,...

QC records lacking for blood bank, letter states.(Blood/biologics)
November 1, 2007... During an FDA inspection of the Washington Hospital Center's, Washington, D.C., blood bank between July 23 and Aug. 16 FDA documented numerous deviations from applicable current GMP regulations for blood and blood components. The company...

Arrow International warned for lack of nonconformity investigations.(Medical devices)
November 1, 2007... During an inspection Jan. 17-Feb. 13, of Arrow International, Reading, PA, FDA found significant regulatory problems involving the catheters and other devices manufactured by Arrow International. FDA also noted the company had previously...