Validation Times articles from October 2006

Validation Times archives from October 2006

FDAer states that decision to discontinue issuance of GMP certificates to be reviewed.(Exports)
October 1, 2006... WASHINGTON -- A senior FDA compliance officer stated here Oct. 5 that the agency had recently discontinued the issuance of GMP certificates that gave a firm clearance to export drug products out of the United States, because there were few...

New guidance on inactives used in generics to be released.(Excipients)
October 1, 2006... WASHINGTON -- FDA's Office of Generic Drugs (OGD) will soon release new guidance explaining the inactive ingredient policy, an official told the Generic Pharmaceutical Assn. (GPhA) scientific conference here Oct. 18. Martin Shimer,...

Trending, training, root cause analysis and change control needed in cleaning studies.(Cleaning validation)
October 1, 2006... WASHINGTON -- When it comes to cleaning validation, FDA expects companies to have written procedures detailing the cleaning processed used for various pieces of equipment, and for how the procedures will be validated--pretty much the same level...

Concerns mounting about safety, competitive advantage of API manufacturers in India and China, Commerce official reports.(APIs)
October 1, 2006... WASHINGTON -- India and China currently account for approximately 40-49% of the production of the global API supply, but this will increase in the next 10 to 15 years to about 80%, which brings to the forefront concerns about how American API...

Generic industry on board with QbR; 50 QbR ANDAs by 20 firms in the pipeline, OGD's Wu says.(CMC)
October 1, 2006... BETHESDA, MD -- Question-based-review (QbR) for generic drugs--to be fully implemented in 2007--is embodied by the quality-by-design (QbD) effort, and is unique because the target product quality profile is well defined, such as, dissolution,...

CAPA and QC flaws cited for Cambridge Major Jabs.(Human drugs)
October 1, 2006... An FDA audit of Cambridge Major Laboratories, Germantown, WI, indicated that the contract lab failed to implement corrective actions in the production of active pharmaceutical ingredients (APIs). For example, the QC unit failed to establish...

Greer receives 16-item 483 for aseptic processing, questionable expiration dates, lab controls, contaminated samples.
October 1, 2006... Greer Laboratories, Lenoir, NC, received a 16-item 483 after a recent GMP inspection for aseptic processing flaws, improper expiration dates on drug products, and for laboratory controls that did not include the establishment of scientifically...

CCS Medical cited for compounding violations in letter.(Human Drugs/Oxygen)
October 1, 2006... An Oct. 19-20, 2005 FDA inspection of CCS Medical, Clearwater, FL, in collaboration with an investigator from Florida's Department of Health, found the company's Tampa facility in violation of drug manufacturing and compounding laws. ...

Retest dating inadequate, states warning letter to Hawkins.(Human Drugs/Oxygen)
October 1, 2006... Hawkins, Minneapolis, MN, which receives APIs from manufacturers and distributors, and subsequently repackages and re-labels them for further distribution for use by pharmacies for compounding of drug products, was in violation of current GMPs...

Failure to maintain appropriate documentation trips up oxygen firm.(Human Drugs/Oxygen)
October 1, 2006... FDA inspected The Service Center, Broadview, IL, which performs both medical oxygen gas transfilling and the refurbishment of used medical oxygen cylinders, on April 5, 10 and 14; and the agency performed a follow-up inspection on May 30, June...

Berkline written up for CAPAs, management controls.(Medical devices)
October 1, 2006... An FDA investigation conducted July 24-31, at Berkline, Morristown, TN, a manufacturer of automated lift chairs, revealed that Berkline was not in conformance with the current GMP requirements of the QS regulation. Violations in the Sept....

Poor quality audits and QS system noted for Biolase.(Medical devices)
October 1, 2006... During an FDA investigation Aug. 8-Aug. 17, the agency determined that Biolase Technology, Irvine, CA, marketer of medical and dental lasers, was not in conformance with the current GMP requirements for medical devices. Significant...

Failure to validate device design noted for Frye Health.(Medical devices)
October 1, 2006... During a July 17-19 FDA investigation of Frye Health Systems, Tulsa, OK, the firm's Frye Adjusting Instrument--a chiropractic device indicated for chiropractic adjustment of the spine and extremities--was adulterated in that the methods used...

Medtronic comes up short with design procedures.(Medical devices)
October 1, 2006... A May 18 June 22 FDA investigation of Medtronic, Minneapolis, MN, determined that the manufacturer of implantable drug infusion and neurostimulation products to treat pain, movement disorders and other medical conditions was not in conformance...