Validation Times articles from August 2008

Validation Times archives from August 2008

CASSS forum focuses on integrating QbD into product lifecycle.(Quality by Design)
August 1, 2008... BETHESDA, MD -- Traditional risk assessments are changing. Drug development and manufacturing companies are now developing formal, documented approaches developed by cross-functional teams of experts to quantify risk. At the July 24-25...

DOE factors into bioassay development, says USP workshop.(Design of Experiments)
August 1, 2008... ROCKVILLE, MD -- Among the biotechnology industry, Design of Experiments (DOE) principles are used to facilitate safe and effective product development. A DOE-based program can benefit biotech teams early on, as they build development programs...

USP workshop examines the role of bioassays in drug development.(Bioassays)
August 1, 2008... ROCKVILLE, MD -- In the field of drug development and throughout a drug's lifecycle, bioassays are often used to characterize new biotechnology products. For a bioassay to move from development to practice, it must first be analyzed and...

Industry experts say successful design spaces require flexibility.(Design Space)
August 1, 2008... BETHESDA, MD -- Building robust and reliable assessment scales to determine criticality affords drug companies more success when defining design space, experts told the July 24-25 CASSS CMC Strategy Forum. Integrating flexibility into a...

Critical Quality Attributes and non-CQAs are valuable to risk assessments, CASSS forum told.(CQAs)
August 1, 2008... BETHESDA, MD -- Risk assessments require both Critical Quality Attributes (CQAs) and non-CQAs to assure quality. At the July 24-25 CMC Strategy Forum held at the National Institutes of Health campus, representatives from biopharmaceutical...

FDA finds insufficient documentation at Banner Pharmacaps.(Human Drugs)
August 1, 2008... Banner Pharmacaps, High Point, NC, failed to provide sufficient documentation for evaluations of products, adequacy of containers and laboratory investigations, an FDA inspection concluded. Investigator Barbara Frazier's three-item 483...

Alberto Culver faulted for lapses in quality control.(Human Drugs)
August 1, 2008... FDA inspector Jorge Lajara found lapses in quality and laboratory systems during an inspection of Alberto Culver Company's manufacturing facility in Puerto Rico. The 483 cited the company's "failure to review thoroughly any unexplained...

Pre-approval inspection nets one GMP deficiency for Pliva Krakow.(Human Drugs)
August 1, 2008... A preapproval inspection of Pliva Pharmaceutical's Krakow drug manufacturing facility yielded one "significant GMP deficiency related to incomplete cleaning validation studies for all multi-use equipment used in the manufacture of Ondansetron...

Manufacturing procedures conflict with GTPs at Donor Services.(Biologics)
August 1, 2008... The procedures required to meet core Good Tissue Practice (GTP) requirements "in the manufacture of HCT/Ps were not followed" at Donor Services of Indiana, investigator Catherine Quinlan found during her inspection. Specifically, the...

FDA finds Harborview testing, documentation procedures lacking.(Biologics)
August 1, 2008... Harborview Medical Center's Department of Laboratory Medicine was cited for failing to properly calibrate testing equipment, incomplete records and failure to document test results for verification of supplies and reagents. FDA...

Manufacturing procedures not in synch with GTP requirements at Oregon Health & Science.(Biologics)
August 1, 2008... The blood banking and infectious disease testing operations at Oregon Health & Science University received a four-item 483 after an FDA investigator found failures in GTP and standard procedures, as well as labeling problems. Investigator...

Re-inspection of Overland Park blood bank finds objectionable conditions corrected.(Biologics)
August 1, 2008... "Objectionable conditions" noted on an eight-item 483 issued after a 2007 inspection of the Overland Park Regional Medical Center's unlicensed blood bank were found largely resolved during a re-inspection May 15-19 by FDA investigator William...

Zomed Zobel hit with 11-item 483 for GTP and procedure failures.(Biologics)
August 1, 2008... Zomed Zobel, a manufacturer of bone and joint restoration products, received an 11-item 483 following inspection by FDA investigator Jessica Hensley for failure to properly track and store its products and to establish and follow procedures to...

G&W Laboratories cited for manufacturing unapproved drugs and misbranding.(Human Drugs)
August 1, 2008... A Dec. 3-20 inspection of G&W Laboratories revealed significant deviations from GMPs for finished pharmaceuticals, which FDA said "caused your finished drugs to be adulterated." The agency also said the firm was making unapproved new drugs...

Anika Therapeutics lacks adequate quality system in manufacturing, FDA says.(Medical Devices)
August 1, 2008... An FDA inspection conducted March 10-21 revealed that the devices Anika Therapeutics manufactures--Amvisc, Amvisc Plus, Staarvisc II, Shellgel and Orthovis--are adulterated because of the firm's lack of conformity with GMPs. Management...

Design controls at Carematix deemed inadequate.(Medical Devices)
August 1, 2008... Carematix Wellness System was cited for a panoply of GMP, MDR and product approval violations, including inadequate design controls, failures to initiate corrective and preventive action (CAPA) and making a variety of claims for the product....