Validation Times articles from January 2003

Validation Times archives from January 2003

PAT rollout to have technical guidance, possibly derived from ASTM, CDRH. (Process analytical technology).
January 1, 2003... SCOTTSDALE, AZ -- Once FDA gets through with implementing some "immediate steps" under its "Pharmaceutical GMPs for the 21 Century" initiative (see below), the agency will issue an overall guidance to industry on how to implement process...

FDA to take 'immediate' steps under new GMP initiative in February. (GMPs).
January 1, 2003... Next month, drugs and biologics makers could start seeing some immediate steps that FDA will take to revamp quality control and inspection programs for these industries under its "Pharmaceutical GMPs for the 21st Century" initiative. ...

Drug makers lag behind other industries in moving to PAT, but Glaxo U.K. using acoustic monitoring. (Monitoring/validation).
January 1, 2003... SCOTTSDALE, AZ -- John McGregor, a professor of chemical engineering at McMaster University in Canada, glanced around the room at the IFPAC meeting here after delivering a talk about using digital camera imaging for monitoring and control of...

Drug chemistry chief only eyeing submission data for complex PAT; comparability protocol seen as alternative. (CMC).
January 1, 2003... SCOTTSDALE, AZ -- FDA's new drug chemistry chief is contemplating some submission data for "complex" PAT approaches in drug manufacturing, but she advised firms to submit a comparability protocol as an alternative and discuss PAT at...

Lilly scientist sees vast use of PAT and FDA acceptance, too. (PAT Tools).
January 1, 2003... SCOTTSDALE, AZ -- While Eli Lilly only uses PAT for its biological products, mainly purification column cleaning, a 30-year veteran chemist for the firm says PAT provides a variety of tools that can be used in other manufacturing and even...

OTC drug maker cited for failures in five 'systems,' plus uncalibrated scales. (Human drugs).(Grafor Manufacturing)
January 1, 2003... Small OTC drug firm Grafor Manufacturing, Ponce, PR, found itself on the short end of a hefty inspection, which appeared to be among the first FDA conducted under its "systems-based" approach to GMP audits. The audit was conducted in...

Purdue improves e-record tracking of Oxycontin adverse events after audit. (Human drugs).(Purdue Pharma)
January 1, 2003... New England District FDA investigator Anthony Warchut was on call to check on Purdue Pharma's progress in accounting for Oxycontin adverse events in a two-day inspection last December, which unearthed problems related to electronic records...

B&L falls short on fill lines disinfectant validation, paint chips 'out of control'. (Medical devices).(Bausch and Lomb)
January 1, 2003... FDA's May 2002 audit of Bausch & Lomb's (B&L) Greenville, SC, facility uncovered lax conditions in the firm's disinfecting of filling lines and questioned the sterility of its eye care products. Atlanta District investigators Claudette...

Genentech avoids warning letter following stability, HEPA difficulties. (Blood & Biologics).
January 1, 2003... Stability, annual product reviews and HEPA filter issues yielded Genentech a two-page 483 following an audit by "Team Biologics" investigators James Evans and Sidney Priesmeyer. The FDAers led their August 2001 observations by noting the...

Black particles at Abbott lead to unvalidated corrective action citing. (Human Drugs).
January 1, 2003... A just-released Sept. 24, 2002, letter cited Abbott's plant in Abbott Park, IL, (Building AP-16) with failure to conduct a thorough investigation "when a batch or any of its components fail to meet specifications." Specifically, the...

API maker method validation protocols singled out by FDA. (Human Drugs).(active pharmaceutical ingredient manufacturer ChemSource)(Brief Article)
January 1, 2003... Active pharmaceutical ingredient (API) manufacturer ChemSource was hit with a failure to have method validation protocols describing the pre-established specifications, parameters and requirements for the method validation studies of Metformin...

Water system at K.C. not up to snuff for ophthalmic drugs. (Human Drugs).(K.C. Pharmaceuticals)(Brief Article)
January 1, 2003... K.C. Pharmaceuticals' purified water system used for making sterile ophthalmic drugs was not validated "with a high degree of assurance," and environmental monitoring systems in aseptic processing areas were deficient, too, FDA said in a...

Australian firm's sterility under par, agency claims. (Human Drugs).(Mayne Pharma Pty. Ltd.)(Brief Article)
January 1, 2003... Melbourne, Australia's Mayne Pharma Pty. Ltd., was the focus of a Nov. 21, 2002, warning letter, which called into question the integrity of the firm's sterility procedures. The letter, issued by CDER's Division of Manufacturing and...

Lack of exec responsibility, calibration lands Serv-A-Pure in hot water. (Medical Devices).(Brief Article)
January 1, 2003... FDA stated that water purification systems used in hemodialysis treatment centers and manufactured by Serv-A-Pure Company, Bay City, MI, were adulterated, according to a Dec. 10, 2002, warning letter issued by the agency. The letter stated...

Spot cone devices adulterated because of no quality systems. (Medical Devices).(Brief Article)
January 1, 2003... Chattanooga, TN-based Standard Tool & Die Inc., was hit by the agency's New Orleans district for manufacturing adulterated spot cone devices, according to a Dec. 2, 2002 warning letter. In the short letter, FDA led off by stating the spot...