Validation Times articles from July 2006

Validation Times archives from July 2006

Development of individualized medicines present validation challenges, FDA tells CASSS attendees.(Process validation)
July 1, 2006... BETHESDA, MD -- Process validation can be particularly challenging with individualized medicines (IMs)--defined as products manufactured specifically for one subject--which are most often autologous therapies using some biological component...

Process validation assurance keys on approach, design, quality and conduct of studies, CBER official says.(CMC/validation)
July 1, 2006... BETHESDA, MD -- Process validation is a necessary element of an overall control strategy to assure quality for each lot of product, but the extent of the assurance provided depends upon several factors, including the approach that is taken to...

Advent of QbD does not mean the end of process validation: Amgen QA exec.(Quality-by-design)
July 1, 2006... BETHESDA, MD -- While there is talk in the industry of moving away from process validation to quality by design (QbD), even with the best that QbD has to offer, "there are simple facts of life relating to running a manufacturing process that...

Movement out of design space is a change that requires a regulatory post approval change process.(Design space)
July 1, 2006... RESTON, VA -- The International Conference on Harmonization's (ICH) Q8 guidance details the concept of design space, which is the established range of process parameters that has been demonstrated to provide assurance of quality. While...

Points to consider in making GLP decision include protocol, QA involvement, lack of SOPs.(GLPs)
July 1, 2006... Whether or not a contract lab should impose Good Laboratory Practices (GLPs) on a particular study is a complex issue, and some of the points to consider when making the decision are whether or not to have a protocol, the level of QA...

Southern Meds nets 18-item 483 for unclean equipment, invalidated sterilization process.(Human drugs)
July 1, 2006... Southern Meds Joint Venture, Biloxi, MS, received an 18-item 483 for failure to maintain clean equipment and utensils, and the firm was cited for poor control procedures, thus drawing a warning letter. Investigator Marion Jones from the New...

Sterility problems and OOS stability results trip up Sanofi Pasteur.(Biologics)
July 1, 2006... Fluzone availability not expected to be affected for flu season, agency states Sanofi Pasteur, Swiftwater, PA, was slapped with a nine-item 483 in a mandatory annual inspection because of numerous sterility problems related to the...

Guilin Pharmaceutical nets letter for insufficient CAPAs stemming from inspection.(Human/animal drugs)
July 1, 2006... A March 13-16 inspection of Guilin Pharmaceutical, Guangxi, China--revealed significant, facility-wide deviations from the current GMP regulations. Only the veterinary drug-manufacturing portion of the facility was inspected. As part of...

Ranbaxy slapped with letter for stability program flaws.(Human/animal drugs)
July 1, 2006... During a Feb. 20-25 inspection of Ranbaxy Labs, Panonta Sahib, India, an FDA investigator from CDER's division of manufacturing and product quality, documented several deviations from the current GMP regulations. Significant violations in...

Potential contamination issues trip up Watson Labs.(Human/animal drugs)
July 1, 2006... FDA inspected Corona, CA-based Watson Labs' Humacao, PR-facility Nov. 3-Dec. 15, 2005, and determined that the facility violated current GMP regulations. Violations included in the June 19 warning letter included failure to handle and...

Electric Mobility cited for CAPAs.(Medical devices)
July 1, 2006... During a Jan.10-Feb. 2 inspection, an FDA investigator found that Electric Mobility, a manufacturer/distributor of electric scooter and powered wheelchairs in Sewell, NJ, was not in conformance with the Quality System regulation. ...

International Resources fails to submit BPDRs.(Blood/biologics)
July 1, 2006... An April 25-May 10 inspection of Lafayette, LA-based International BioResources's--which operates plasma-donation centers--Ft. Worth, TX-facility revealed significant deviations of the current GMP regulation regarding the company's product,...

Failure to control aseptic conditions nets letter for Sanofi Pasteur.(Blood/biologics)
July 1, 2006... An April 18-28 investigation of Sanofi Pasteur, Swiftwater, PA, conducted by FDA's Office of Regulatory Affairs (ORA) /Office of Enforcement's (OE) division of compliance management and operations found significant and extensive violations of...