Validation Times articles from January 2007

Validation Times archives from January 2007

USP "open" to further delay in implementing Chapter <467>.(USP/PDA Conference)
January 1, 2007... NORTH BETHESDA, MD -- the U.S. Pharmacopeia will consider "pushing out" the scheduled July 1 implementation date for its new General Chapter on residual solvents in existing drugs, said the organization's Vice President of Standards...

Regulators, industry provide varying views on new residual solvents rules.(USP/PDA Conference)
January 1, 2007... Manufacturers of Rx brand, generic, OTC products and excipients face varying challenges and issues in complying with the new USP Chapter , which FDA will rely upon and enforce, said presenters at the USP/PDA conference. Rosa Motto,...

CDER puts QbD into practice; 'regulatory relief' incentive seen.(Quality-by-design)
January 1, 2007... PHILADELPHIA -- In a broad-stroke presentation that touched on how new guidance and initiatives are being applied by CDER's Office of Compliance, Mr. Kristen Evans, senior regulatory operations officer with the office's Guidance and Policy...

European authorities opted to apply ICH broadly.(USP/PDA Conference)
January 1, 2007... NORTH BETHESDA, MD -- An emphasis on ensuring patient safety caused the European Union (EU) and the European Medicines Agency (EMEA) to adopt the residual solvents standards devised by ICH across the board, explained John Michael Morris, Ph.D.,...

Speakers suggest strategies to meet new USP residual solvent requirements.(USP/PDA Conference)
January 1, 2007... NORTH BETHESDA, MD -- Drug manufacturers should take a risk-based approach to identifying and when necessary, quantifying residual solvents in their products to ensure compliance with USP Chapter , which includes understanding how to translate...

Sterility problems, validation and CAPAs net 45-item 483 for K.C. Pharmaceuticals.(Human drugs)
January 1, 2007... K.C. Pharmaceuticals, located in Pomona, CA, received a big 45-item 483 that cited many sterility and validation problems, according to an FDA report prepared by investigators Terri Dodds and Katherine Jacobitz from the Irvine, CA, District...

Inadequate quality policy, process validation nets 9-item 483 for B. Braun Med.(Human drugs)
January 1, 2007... Poor implementation by management of an effective quality policy and lack of process validation, according to FDA records, netted a nine-item 483 and warning letter for B. Braun Med, Cherry Hill, NJ. Investigator Karen Tomaziefski from the...

Compounding pharmacy tripped up by microbial contamination.(Human drugs)
January 1, 2007... New England Compounding Center, Framingham, MA, was inspected Sept. 23, 2004, where the compounder of human prescription drugs, including such products as trypan blue ophthalmic products, was found to have problems with microbial contamination...

Applied Water Engineering cited for validation flaws and lack of design changes.(Medical devices)
January 1, 2007... Applied Water Engineering, Salt Lake City, UT, the manufacturer of PA2000 and SPD reverse osmosis water purification systems for dialysis, was inspected by FDA July 11-14, 2006. At that time the company was found to be in violation of the...

Biotecx written up on specification procedures, design validation.(Medical devices)
January 1, 2007... A September inspection of Biotecx Laboratories, Houston, TX, the manufacturer of Opticoat T3 and T4 EIA (Enzyme Immunoassay) kits, found that the firm was in violation of current GMPs of the Quality System regulation. Specifically, the...

Quality system flaws and product control procedures trip up Lee Labs.(Medical devices)
January 1, 2007... A Sept. 25-27, 2006, inspection of Lee Laboratories, Ponca City, OK, determined that the manufacturer of extra-oral orthodontic headgear was not in conformance with the Quality System regulation in the following ways: Management failed to...

MRL warned for CAPA procedures and device design.(Medical devices)
January 1, 2007... FDA's May 22-July 20, 2006 inspection MRL, Buffalo Grove, IL, a manufacturer of automatic external defibrillators, were not in conformity with the current GMP requirements of the Quality System (QS) regulation. Violations noted in the Dec....

Nasiff Associates cited for acceptance/rejection procedures.(Medical devices)
January 1, 2007... FDA Oct. 12-18, 2006 inspected Nasiff Associates, Central Square, NY, the manufacturer of the Cardio-Card Interpretation System, and determined the device manufacturer's products were not in conformance with GMP/Quality System regulations the...

Quick-Fill Mobile cited for equipment calibration.(Medical devices)
January 1, 2007... The agency's Aug. 14, 15 and 18, 2006, inspection of a compressed oxygen manufacturing facility of Quick-Fill Mobile Oxygen, Gulfport, MS, found what it termed to be significant violations of current GMPs, which included but were not limited to...