Validation Times articles from December 2005

Validation Times archives from December 2005

Final responsibility in cold chain management falls upon applicant, says senior CBER inspector.(Cold-chain distribution)
December 1, 2005... RESTON, VA -- In cold chain management--the system of transporting and storing temperature-sensitive products through a distribution chain within a specified-temperature tolerance range--FDA's point-of-view is that it is the applicant's...

Isolator use encouraged by agency, but proper decontamination procedures essential.(Aseptic processing/cleaning)
December 1, 2005... RESTON, VA -- Although FDA's 2004 guidance document on aseptic processing provides strong encouragement for the use of isolators in place of cleanrooms, this hinges upon companies demonstrating superior cleaning practices for their isolators,...

Agency letter on DEHP risk a 'good case study showing' FDA's approach, CBER official states.(Packaging/PVC)
December 1, 2005... RESTON, VA -- The steady increase in the use of disposables to produce biopharmaceuticals has caused FDA to face head-on the problem of Di(2-ethylhexl) phthalate (DEHP) released from polyvinyl chloride (PVC), which is used to produce many...

Cell cultures, elastomers, GMP failures: common 483 concern areas with disposables.(Medical devices)
December 1, 2005... RESTON, VA -- Some of the most common 483 observations in the use of PVC disposable medical devices in the production of biopharmaceuticals fall into three general areas: cell cultures, elastomers and GMP failures, CBER's John Finkbohner told...

Acambis executive urges agreements when contracting out most QA functions, but more specifics needed.(Quality agreements)
December 1, 2005... Drug, device and biologics' manufacturers should have a "quality agreement" with any contract manufacturing organization (CMO) prior to the initiation of GMP activities at the contractor, and even have a supplier agreement for vendors, in order...

Allowash cleans bone for tissue grafts to less than .01 microliter of blood elements per gram of wet weight, says LifeNet senior executive.(Tissue)
December 1, 2005... RESTON, VA -- LifeNet, a full organ donation agency in Virginia Beach, VA, has used Allowash--a family of technologies designed to produce safe human tissue grafts for use in orthopedics--to process and distribute nearly one million tissue...

Biogen cited for cleaning/autoclave validation, faulty filter extractable studies.(Human drugs)
December 1, 2005... Biogen Idec's Research Triangle Park, NC, facility was handed a three-item 483 in a recent pre-approval inspection because "bulk drug substance container/closure cleaning and autoclave validations were incomplete," and "filter extractable...

BSC chastised for 'complete failure of quality system' in 15-item FDA write-up.(Medical devices)
December 1, 2005... Boston Scientific Corporation (BSC), Quincy, MA, received harsh criticism from the agency in a 15-item 483 and an Aug. 10 warning letter because products were not adequately controlled when they did not conform to specifications. The...

Bone screw manufacturer cited for calibration errors, management failure to implement quality system.
December 1, 2005... Global Manufacturing & Engineering, Ocean Springs, MS, received an eight-item 483 for failure to establish calibration procedures "with specific directions and limits for accuracy and precision," and for failure of management to implement an...

G&S cited for failure to properly establish design change procedures.(Medical devices)
December 1, 2005... An Oct. 19-Nov. 2 inspection of G&S Instrument Co., Midlothian, TX, determined that the firm was not following current GMP/Quality System (QS) rules, and that several violations were repeat deviations from the previous inspection conducted by...

Genetic Testing slapped with warning letter for improper validation procedures.
December 1, 2005... A recent FDA inspection determined that Genetic Testing Institute's PF4 Enhanced ELISA kit was adulterated and misbranded, per regulations. Specifically, the Nov. 14 warning letter stated that the Waukesha, WI-base firm added an unnamed...

Globalemed does not have premarket approval, letter says.
December 1, 2005... An FDA audit of Globalemed, LLC, Alexandria, VA, determined that the firm, which purchases and distributes in vitro diagnostic test kits, was not in conformance with the QS regulation and did not have premarket approval. Further violations...

Primary Care fails to validate devices, according to warning letter.
December 1, 2005... Following a recent inspection of Primary Care Solutions, Zephyrhills, FL, FDA determined that the manufacturer and distributor of sterile water and saline in bottles, cups and sterile pre-filled inflation syringes used for irrigation and...

Poor procedures for complaint-handling trips up Sweet Dreams.
December 1, 2005... A Sept. 27-30 inspection determined that Sweet Dreams, Westerville, OH, was not in conformance with the QS regulation. The firm manufactures an infant soother. Violations included in the Nov. 9 warning letter were failure to record and...