Validation Times articles from January 2005

Validation Times archives from January 2005

PAT training for investigators focuses on evaluating guidance comments, preoperational visits, inspections.(Process analytical technology)
January 1, 2005... ARLINGTON, VA -- FDA's approach to training investigators on how to inspect pharmaceutical firms' use of process analytical technology (PAT) concentrates on the evaluation of industry comments on PAT guidances, as well as participating in...

EMEA to draft new quality guideline, other guidance in 2005.(Europe)
January 1, 2005... WASHINGTON -- The European Medicines Evaluation Agency (EMEA) will be working on various guidance in 2005 concerning "biosimilar products", plus a new quality guide, some non-clinical and clinical guidelines and a product/class-specific...

A 'high degree of assurance' can be achieved in many ways, FDAer says.(Process validation)
January 1, 2005... WASHINGTON -- Process validation is defined as "establishing a high degree of assurance," according to CDER's Barry Cherney, Ph.D, but there is some controversy as to what "assurance" means. Addressing the CaSSS meeting here Jan. 10,...

7 major drug firms identify uses of PAT.(Company roundup)
January 1, 2005... WASHINGTON -- Various makers of human drugs and biologics reported this month on how they are applying PAT in their manufacturing and QA, including drying, purification, wet-granulation and process validation. The addresses were made at...

Physical Sciences, Inc. experiments with improved lyophilization methods in PAT.(Freeze-drying and PAT)
January 1, 2005... ARLINGTON, VA -- The use of a real-time monitor for the water removal rate during lyophilization is superior to the traditional approach to freeze dryer process control, which has had problems with sterility, freezing bias with sensors and...

Wyeth hit with 54-item 483 for OOS results, faulty aseptic results, HVAC.(Human drugs)
January 1, 2005... Wyeth, Pearl River, NY, was hit with a 54-item 483 for doses out-of- specification, faulty aseptic operations, and many other violations. The audit was performed by investigators Paula Trost, Robert Jennings and microbiologist Dennis Guilfoyle...

NeuroMetrix receives 2-item 483 for flaws in CAPA systems.(Medical devices)
January 1, 2005... NeuroMetrix, a Waltham, MA-based manufacturer of Class II nerve conduction systems used for the diagnosis of carpal tunnel syndrome, was slapped with a two-item 483 in an initial inspection for inadequate corrective and preventive action (CAPA)...

Stability, batch failures, OOS results cited at ABC Compounding.(Human drugs)
January 1, 2005... ABC Compounding Company, Inc., Morrow, GA, which manufactures antibacterial hand soaps, cleaners and sanitizers for over-the-counter distribution, was cited in a Nov. 1 warning letter for stability, batch failures and out-of-specification (OOS)...

Lincare compounding drugs that were commercially available.
January 1, 2005... Subsequent to a June 16-18 audit of Lincare, Inc., and Reliant Pharmacy Services, Clearwater, FL, FDA found that the human drug compounding facility in Mississippi was compounding products in enormous amounts of what were copies of commercially...

In-vivo bioavailability studies lack validity at MDS Pharma; contamination cited.
January 1, 2005... From Sept. 13-Oct. 1, investigators from CDER's Scientific Investigations Branch inspected several bioequivalence studies conducted by MDS Pharma Services, in Montreal (Quebec), Canada, and noted concerns about the validity of its...

Validation, sterility QC triggered Chiron GMP problems and vaccine shortage.(Biologics)
January 1, 2005... Following the U.K. decision to not allow the export of its flu vaccine, Fluvirin, thus tripping a widespread shortage in the U.S., FDA conducted an inspection Oct. 10-15 of Evans Vaccines, a U.K. affiliate of Chiron Corp., Emeryville, CA. The...

Alveolus cited for CAPA, design validation and quality plan issues.(Medical devices)
January 1, 2005... A warning letter to Alveolus, Inc., Charlotte, NC, cited the device distributor and specifications developer with failure to verify, validate or maintain procedures for implementing CAPAs. FDA also found during an audit July 13-27 that...

Serious quality system failures found at Aurora.
January 1, 2005... During an inspection on Sept. 13, 14, 15, 16 and 23 of the manufacturer of the Aurora Dedicated Breast MRI System device, FDA found serious quality system failures, including problems with the quality policy and system, CAPA procedures and...

Kegelmaster lacks CAPA policies.
January 1, 2005... An Aug. 6 inspection of Kegelmaster 2000 Ltd., Sarasota, FL, found the company did not establish CAPA procedures to comply with the QS regulations addressing the manufacture and distribution of its device. The company makes the Kegelmaster...

Nuclear Cardio Systems hit with design validation, complaint-handling violations.
January 1, 2005... Nuclear Cardio Systems, Inc., Boulder, which manufactures and remanufactures emission computed tomography systems, was found to have numerous deviations from the QS regulations, including a lack of validation for its device design plan, CAPA...

Producer of bone screws cited for validation problems.
January 1, 2005... An FDA inspector visiting Precision Piece Parts, Mishawaka, IN, from Aug. 30-Sept. 21, determined the manufacturer of ilio-scral bone screws, as well as other medical products, considered to be devices, did not perform verification or...