Validation Times articles from October 2005

Validation Times archives from October 2005

Drug Quality Assessment System uses QbD, 'design space' in move to new paradigm; QbR, scoring system raise generics' concerns.(CMC)
October 1, 2005... By Validation Times Staff NORTH BETHESDA, MD -- Center for Drugs' new risk-based Pharmaceutical Quality Assessment System (PQAS), which is based on "scientific knowledge and understanding of product and process by applying...

FDA approach to updating 1987 DS guidance draws SOCMA members' ire.(APIs)
October 1, 2005... ALEXANDRIA, VA -- An FDA senior chemist spoke here Oct. 5 about agency efforts to update the 1987 Drug Substance (DS) Guidance, but the agency's approach came under fire from attendees for its failure to include risk-based approaches to drug...

New proposed rule on Part 11 seen in late 2005 or early 2006, FDAer says.(Electronic records)
October 1, 2005... ALEXANDRIA, VA -- An FDA working group that is reviewing the 1997 electronic signature /records regulation (21 CFR Part 11) is writing a new proposed rule that should be published in late 2005 or early 2006, an FDA official announced here Oct....

Review 'checklist' still desired by some firms, but AAPS/ISPE panel recommends 'no'.(CMC)
October 1, 2005... By Validation Times Staff NORTH BETHESDA, MD -- A checklist that firms and FDA can use to determine whether a CMC submission is complete still is desired by several pharmaceutical firms, and were referenced by two separate "breakout...

AAPS/ISPE panels feel quality summary should be ICH document.(QOS)
October 1, 2005... By Validation Times Staff NORTH BETHESDA, MD -- While FDA's move to the new "quality overall summary" (QOS) has won praise from industry, a breakout session on the issue reported here that the document should pass ICH muster before it is...

Generic drugs to be scored based on risk.
October 1, 2005... Addressing the Generic Pharmaceutical Assn. technical conference in Washington Oct. 25, OGD officials outlined their QBR program, which they hope will cut down on reviewer time and questions. Under QbR, companies will provide the answer to...

3M receives 2-item 483; cleaning validation problems noted in EIR.(Human drugs)
October 1, 2005... Cleaning validation problems befell 3M's Northridge, CA, facility, although the observations were not included in the two-item 483 the company received. According to the EIR, the Northridge facility makes prescription tablets, aerosols and...

Packager slapped with 4-item 483 for failing to follow protocol during several validation studies.
October 1, 2005... Carton Services, Norris, TN, was hit with a four-item 483 because it did not follow protocol during validation studies. According to FDA documents, Carton Services manufactures paperboard cartons, some of which contain pharmaceutical or...

Faulty process control procedures, equipment maintenance trip up Inova.(Medical devices)
October 1, 2005... Inova Diagnostics, San Diego, received a 483 because process controls procedures that "describe any process controls necessary to ensure conformance to specifications were not defined." Also, the company failed to establish the adjustment,...

Control procedures and OOS net letter for CEPH International.(Human drugs)
October 1, 2005... FDA inspected CEPH International Corp, Caguas PR, from March 21-April 22 and found that the human drugs Omnicef OP 250mg/5m1 and 125mg/5m1, which the firm manufactures, to be adulterated. Violations cited in the Sept. 13 letter included...

Device acceptance, acceptance / rejection SOPs trip up Electro Medical.(Medical devices)
October 1, 2005... A June 28 July 22 inspection of Electro Medical, Tulsa, OK, concluded that the firm did not conform to GMP requirements for manufacturing the Stim Flex Model 400 and Model 400A Transcutaneous Electrical Nerve Stimulators as set forth in the QS...

Lobob Labs fails to conduct quality audits and explain non-conforming product.
October 1, 2005... During an inspection of Lobob Labs, San Jose, CA, from March 30-April 28, FDA concluded that the firm did not conform to GMP requirements of the QS regulations for manufacturing its sterile ophthalmic solution. FDA noted in the Sept. 30...

Norva Parker receives letter for lack of procedures for finished device acceptance.
October 1, 2005... After a June 30 July 19 inspection of Norva Parker, Muskogee, OK, FDA determined that the contract manufacturer of the Stim Flex Model 400 and 400A transcutaneous electrical nerve stimulator for pain relief was not in conformity with the...

Tyco Healthcare Group cited for validation flaws and CAPA failures.
October 1, 2005... After a Jan. 18-March 24 investigation of Tyco Healthcare Group, Mansfield, MA, FDA determined that the company was not in conformance with current GMP requirements of the QS regulation regarding the following products:...

Ulrich GmbH & Co. slapped with letter for CAPAs and process controls.
October 1, 2005... FDA conducted an inspection of Ulrich GmbH & Co., KG, Ulm, Germany, from April 11-14 and determined that the manufacturer of spinal implants and associated accessories was in violation of the current GMP requirements of the QS regulation. ...

Visual Telecommunications Network short on control design processes and QS system procedures.(Human drugs)
October 1, 2005... During a June 28 July 8 inspection of Visual Telecommunications Network (VTN), McLean, VA, FDA found that the medical device specification developer of the ViTelCare Turtle 800 Home Patient Monitoring System (Turtle 800) and ViTelCare Turtle...