Validation Times articles from September 2006

Validation Times archives from September 2006

New guidance on quality systems approach to GMPs 'imminent'; Part 11 guidance due 'sometime next year': Famulare.(Electronic records/QS)
September 1, 2006... WASHINGTON -- The release of a new guidance for industry on a quality systems approach to pharmaceutical GMPs is imminent and will be released any day, and a revision of another guidance on revising the agency's electronic records regulations...

FY '06 GMP inspection selection keys on product, process and facility, says CDER official.(Inspections)
September 1, 2006... WASHINGTON -- Sites are chosen for GMP inspections based upon product, process and facility, with an empirical score assigned according to product quality risk and availability and quality of data sources, stated John Gardner, M.D., director of...

Q8/9/10 the foundation of an effective quality system: CBER's Norwood.(Quality systems)
September 1, 2006... WASHINGTON -- An effective quality system integrates the concepts of ICH Q8, 9 and 10, and provides the necessary framework for implementing quality-by-design (QbD), and these three documents will have an impact on regulatory inspections in the...

PAT not same as Q8, but 'framework on how to' implement ICH guidance.(PAT)
September 1, 2006... WASHINGTON -- Process analytical technology (PAT) is a framework for achieving compliance with ICH's Q8 "Pharmaceutical Development" guidance, and thus a means to get regulatory relief from the agency's CMC requirements, FDA's Jon Clarke told...

Kutol Products receives 4-item write-up citing CAPAs, lab controls.(Human drugs)
September 1, 2006... Kutol Products, Cincinnati, OH, received a four-item 483 because of problems with corrective and preventive actions (CAPAs) and because of faulty laboratory controls. The investigation team from FDA consisted of investigator Mark Parmon...

Multiple 483s given to Vi Jon Labs for process validation, equipment cleaning.
September 1, 2006... Two inspections of Vi Jon Laboratories, St. Louis, MO, revealed poor process validation for dandruff shampoo and a lack of regular calibration of equipment, as well as poor written procedures for equipment cleaning. Both inspections were...

CAPAs procedures unclear, procedures for equipment calibration not established, notes 11-item 483.(Medical devices)
September 1, 2006... Advanced Imaging Research, Cleveland, OH, was slapped with an 11-item 483 following a 2006 inspection due to improper CAPA procedures. An April 20 warning letter also was issued. Conducting the audit was investigator Benjamin Dastoli from...

Pascal slapped with warning letter citing written procedures, equipment cleaning.(Human drugs)
September 1, 2006... A March 28-April 18 FDA inspection of Pascal Company, Bellevue, WA, documented significant deviations from current GMPs, including failure to establish appropriate written procedures, failures of equipment design, failure in cleaning and...

Chien Ti slapped with letter for validation and device design flaws.(Medical devices)
September 1, 2006... An April 17-20 inspection of Chien Ti Enterprise, a manufacturer of mobility scooters and power chairs found that the firm failed to adhere to a variety of FDA regulations, notably validation and verification of device designs. ...

Command Medical lacking in quality requirements for suppliers.
September 1, 2006... An FDA inspection conducted May 11, 12, 15-17 and 19 of Command Medical Products, Ormond Beach, FL, found that the manufacturer of Huber IV Sets was not in conformity with the Quality System Regulation, in that it failed to establish and...

Pointe Scientific slapped with letter for design control and computer validation faults.
September 1, 2006... Failure to conduct proper validation, including software validation, led to an Aug. 11 warning letter to Pointe Scientific in Canton, MI, following an May 4-June 16 audit that primarily found that methods used in, or the facilities or controls...

Sonotech receives letter for DMRs, software, quality audits.
September 1, 2006... An FDA inspection Sonotech, Bellingham, WA, documented significant violations of the Quality System regulation, including failure to establish procedures for finished device acceptance, failure to establish device master records (DMRs), failure...

Wallach Surgical Devices cited for validation flaws.
September 1, 2006... FDA performed an inspection June 6-9 of Wallach Surgical Devices, Orange, CT, which makes the Endocell Endometrial Cell sampler, the Inseminator Catheter and the LL100 Cryosurgical system. It was found that Wallach's devices did not conform to...