Validation Times articles from April 2005

Validation Times archives from April 2005

FDA sees guidance on GMPs for IND products by year's end, focusing on risk, examples of what applies in certain phases.(Clinical supplies)
April 1, 2005... RESTON, VA -- FDA by year's end is expected to issue a draft guidance on how much of GMPs industry needs to follow for clinical drugs, depending on the phase of study, a top Center for Biologics official said here April 26. Christopher...

Biopharmaceutial classification system, statistical methods touted to set specs; 'new paradigm' advocated.(Drug specifications)
April 1, 2005... BETHESDA, MD -- There are continued calls from industry to adopt a "new paradigm" for setting drug specifications, including using statistical methods and expand FDA's biopharmaceutical classification system (BCS). Addressing a Product...

Several EU guides on horizon for viral clearance, GMPs in clinicals; PQR1 to examine viral safety.(Viral clearance)
April 1, 2005... RESTON, VA -- The European Medicines Agency (EMEA) has several new documents in the works that could affect the level of GMPs manufacturers need to apply in clinical trials, particularly regarding viral clearance with biotechnology drugs, and...

Moving from cell-based to binding assays advisable, but expensive, ex-FDAer says.(Bioassays)
April 1, 2005... RESTON, VA - While moving from cell-based bioassays to binding assays for validation of biotechnology products is desirable, the cost is huge, and companies need to discuss this with FDA as well as submit to them a comparability protocol, an...

PFAB Lp cited in 10-item 483 for multiple equipment failures, OOS results.(Human drugs)
April 1, 2005... PFAB Lp (PharmaFab), Grand Prairie, TX, received a 10-item 483 for allegedly failing to use equipment of appropriate design in the manufacturing of drug products, failure to clean and maintain equipment and utensils, and numerous OOS...

Biomerieux slapped with 23-item 483 citing validation, CAPA and MDR flaws.(Medical devices)
April 1, 2005... Biomerieux, Durham, NC, received a 23-item 483 for flaws in process validation and in corrective and preventive actions (CAPAs), and because Medical Device Reports (MDRs) were not submitted to FDA within 30 days. Investigators Claudette...

8-item 483 issued to blood bank for equipment failures.(Biologics)
April 1, 2005... Multiple equipment failures in violation of blood GMPs (21 CFR Part 606) resulted in an eight-item 483 for Community Blood Center of Greater Kansas City, Kansas City, MO. Lenexa, KS, District Office investigators William Lagud, Robert...

Herbal firm cited for failures to follow up on complaints, poor SOPs.(Human Drugs)
April 1, 2005... An inspection of Alternative Health & Herbs, Albany, OR, on Sept. 13-17, 2004, revealed deviations from GMPs for finished pharmaceuticals. Violations cited in the March 17 warning letter included that several of the drug products intended...

Palace Pharmacy cited for compounding of domeridone; owner rips agency.(Human Drugs)
April 1, 2005... On Sept. 13, 2004, investigators from FDA's Denver District and the Wyoming State Board of Pharmacy inspected Palace Pharmacy, Lander, WY, a compounder of human Rx drugs and found several compliance violations, thus leading to a March 23...

Product adulteration and contamination cited for patient first.(Human Drugs)
April 1, 2005... During an auturnn inspection of Patient First, a drug repackaging company in Glen Allen, VA, FDA cited violations of GMP regulations, including product adulteration and contamination, according to a March 15 warning letter. The audit by FDA's...

Animas fails to implement CAPA procedures.(Medical devices)
April 1, 2005... Animas, a manufacturer of insulin infusion pumps, was not in conformance with either current GMP/Quality System regulations or MDR requirements when FDA inspected its West Chester, PA, plant from Sept. 2-Oct. 18, 2004, according to a Feb. 24...

Device manufacturer lacks acceptance /rejection procedures.(Medical devices)
April 1, 2005... A Jan. 10-12 inspection of Professional Specialties Co., Memphis TN, determined the firm's protective restraints and wheelchair accessories did not conform to the current GMP requirements of the QS regulations. According to a March 1...

Tosoh warned for lack of design control procedures.(Medical devices)
April 1, 2005... An inspections in June 2004 and a follow-up audit in August-September of Tosoh Bioscience, South San Francisco, revealed serious regulatory problems involving immunoassay diagnostic packs and immunoassay systems, according to a March 22 warning...

Tyco healthcare cited for failure to monitor and control process parameters.(Medical devices)
April 1, 2005... During an inspection of Tyco Healthcare's Tijuana, Mexico, manufacturing site Nov.1-5, 2004, FDA determined the maker of CapnoProbe SLS-1 Sublingual Sensors was not in conformity with GMP/QS rules, according to the Feb. 25 warning letter. ...