Validation Times articles from January 2009

Validation Times archives from January 2009

Concerns raised with new FDA guidance, comment period extended to Feb. 11.(Process Validation)
January 1, 2009... WASHINGTON -- After several years of development, FDA has issued a draft version of its "Guidance for Industry: Process Validation--General Principles and Practices," but while the new recommendations are in various ways an extension of those...

"Continued Process Verification" brings 1987 guidance into 21st century.(Process Validation)
January 1, 2009... WASHINGTON -- The old saying, "if it isn't broken, don't fix it," doesn't always apply to pharmaceutical manufacturing, especially when the lifecycle approach is quickly becoming standard practice. Continuous assessment and improvement are now...

Pharmaceutical companies establish consortium to secure drug supply chain.(Supply Chain Safety)
January 1, 2009... BALTIMORE, MD -- The newest initiative to secure the pharmaceutical supply chain doesn't stem from Congress or FDA. In fact, it's the brainchild of Martin Van Trieste, Amgen's vice president of quality for commercial operations. At the 2009...

Academics and industry leaders partner to implement continuous manufacturing--the next step in QbD.(Quality by Design)
January 1, 2009... BALTIMORE, MD -- A crucial element of Quality by Design (QbD) is the application of knowledge gained throughout a drug product's lifecycle. The acquisition and use of this information is a cyclical practice, one that will ideally improve each...

Process validation and testing assurance needed at Anacapa Technologies.(Human Drugs)
January 1, 2009... Anacapa Technologies, a manufacturer of antimicrobial skin and wound care products, received a three-item 483 following a July 16-23, 2007, inspection. FDA inspector Virgilio Facio found that the San Dimas, CA, company had not established...

Neil Laboratories violates GMPs.(Human Drugs)
January 1, 2009... Staff size, high turnover and vacancies contributed to the eight-item 483 received by Neil Laboratories during an inspection Dec. 12-28, 2005. According to the documents, FDA inspector Russell Glapion found multiple GMP violations, and...

Vintage Pharmaceuticals fails to follow testing SOPs.(Human Drugs)
January 1, 2009... An inspection of Vintage Pharmaceuticals based in Huntsville, AL, revealed problems with laboratory controls and records, test devices and procedures and sterility processes. FDA investigator Lesley Satterwhite inspected the company's...

FDA inspection results in 8-point 483 for Stryker.(Medical Devices)
January 1, 2009... Cited for its failure to submit correction and removal reports when recalling out-of-specification (OOS) orthopedic implants following a June 1 July 12, 2007, inspection, Stryker Orthopaedics was reported for several GMP non-conformities. ...

Unauthorized compounding at Civic Center Pharmacy.(Human Drugs)
January 1, 2009... Dec. 16--Los Angeles District A July 15 inspection revealed that Scottsdale, AZ, Civic Center Pharmacy compounds drugs using the bulk substance estriol, which is not an active ingredient contained in any FDA-approved drug. FDA does not...

FDA questions process validity at Contract Medical Manufacturing.(Medical Devices)
January 1, 2009... Nov. 20--New England District GMPs were found to be lacking at Contract Medical Manufacturing (CMM), a sterile custom cranial implants producer, according to a Nov. 20 warning letter. A Sept. 10-25 inspection of the Oxford, CT, company...

Quality systems lacking at Eagle Parts and Products.(Medical Devices)
January 1, 2009... Nov. 14--Atlanta District Eagle Parts and Products, a powered wheelchair manufacturer based in Augusta, GA, did not conform to GMPs on several counts, according to a Sept. 15-16 inspection. According to FDA's Nov. 14 warning letter,...

Haemonetics Corporation fails to establish CAPA procedures.(Medical Devices)
January 1, 2009... Dec. 4--Chicago District FDA investigators found several GNP violations related to thromboelastograph device and accessory manufacturing while inspecting Haemonetics on June 26, 27, 30 and July 1 and 3, according to a Dec. 4 warning...

July inspection of Pneumex reveals compromised devices.(Medical Devices)
January 1, 2009... Dec. 5--Seattle District Due to the firm's failure to secure approved applications for PMAs or IDEs, Pneumex's Pneu-MAP and Pneu-Back Chair devices were deemed adulterated following a July 28-29 inspection. The agency also determined the...

Spacelabs Healthcare fails to comply with GMPs.(Medical Devices)
January 1, 2009... Nov. 3--Seattle District Spacelabs Healthcare, Issaquah, WA, which manufactures patient monitors and telemetry equipment for remote monitoring, was cited for not conforming to GMPs following an April and May FDA inspection. According...

Misbranding and GMP violations at Surgical Implant Generation Network.(Medical Devices)
January 1, 2009... Nov. 18--Seattle District Following a July 22-23 and Aug. 12 inspection, FDA found that Surgical Implant Generation Network's facility, which manufactures the SIGN IM Nail and SIGN Fin Nail medical devices, was not in conformance with GMP...

Craig General Hospital disregards SOPs.(Blood & Biologics)
January 1, 2009... Dec. 15--Dallas District Citing "serious violations that reveal problems with your firm's GNP" during a July 20-28, Aug. 1 and Aug. 26 inspection of Craig General Hospital, FDA concluded that the Vinita, OK, hospital failed to follow...

University of Colorado Hospital cited for GMP deviations.(Blood & Biologics)
January 1, 2009... Dec. 23--Denver District During a July 24-Sept. 11 inspection of University of Colorado Hospital blood bank in Aurora, CO, an FDA official noted several failures related to testing and proper follow-up. For example, according to a Dec....