Validation Times articles from July 2008

Validation Times archives from July 2008

First phase of new regulations governing plumbing, aseptic processing to be out 'shortly,' ICH Q10 undergoing revision.(GMPs)
July 1, 2008... BOSTON -- The first phase of FDA's efforts to update the 1978 drug GMPs concerning plumbing, aseptic processing, asbestos filters, verification by a second individual, and other minor changes, could be out shortly, and ICH Q10 regarding Quality...

FDA publishes new guidance for Phase I clinical trials.(Clinical supplies/GMPs)
July 1, 2008... FDA has issued a new guidance document for manufacturers of drugs used in Phase I clinical trials, replacing guidance issued 17 years ago. The July-dated document, "Guidance for Industry: GMP for Phase I Investigational Drugs" represents...

Post-approval management plan eyed for all CMC changes under new guidance.(CMC)
July 1, 2008... BOSTON -- The post-approval management plan (PMP), previously known as the CMC regulatory agreement, is now a customized regulatory framework to manage and implement post-approval CMC changes, a top CDER official told the Drug Information Assn....

FDA seeks volunteers for QbD pilot with biotech drugs; CDER officials outline benefits at DIA.(CMC)
July 1, 2008... FDA's Office of Biotechnology Products is seeking drug companies to volunteer for a quality-by-design (QbD) pilot, this time on defining "clinically relevant attributes for complex products and linking them to the manufacturing process,"...

Design of experiments focused on impurities, rankings suggested for biotech QbD submissions.(QbD)
July 1, 2008... BETHESDA, MD -- Biotech drug makers interested in using the Quality by Design (QbD) approach in their CMC submissions should pay particular attention to impurities and use design of experiments (DOE) to determine these and other product...

Akorn nets 22-item 483 for validation and quality deviations.(Human drugs)
July 1, 2008... Akorn, a drug manufacturer in Decatur, IL, received a 22-item 483 following a 2007 GMP audit because procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not have adequate validation of the...

Discrepancy review flaws nets Altaire 4-item 483.(Human drugs)
July 1, 2008... Altaire Pharmaceuticals, Aquebogue, NY, received a four-item 483 for allegedly failing to review any unexplained discrepancy whether or not the batch had already been distributed. Investigator James Liubichich from the Jamaica, NY, District...

Quality control problems net Elge 14-item 483.(Human drugs)
July 1, 2008... Elge, Rosenberg, TX, received a 14-item 483 because the responsibilities and procedures applicable to the quality control unit were not fully followed. Investigators Edwin Ramos and Stephen Brown from the Dallas, TX, District Office...

Physio Control hit with 32-item 483 for design verification and software flaws.(Medical devices)
July 1, 2008... Physio Control, Redmond, WA, was slapped with a 32-item 483 because "design verification did not confirm that the design output meets the design input requirements," and because software was not fully validated, according to the report prepared...

Elge warned for laboratory control failures.(Human drugs)
July 1, 2008... FDA found Elge, Rosenberg, TX, in violation of GMPs in the manufacture of prescription and OTC drug products for human use following an inspection Jan. 14- Feb. 14. The agency also determined that the company is marketing unapproved drugs and...

Medi-Stat cited for failure to conduct identity tests.(Human drugs)
July 1, 2008... FDA found Medi-Stat, Mobile, AL, a compounder of Rx drug products, in violation of the Food, Drug & Cosmetic Act and GMP regulations because the controls and procedures used in their manufacture, processing, packing and holding did not conform...

Device firm cited for failure to establish quality system procedures.(Medical devices)
July 1, 2008... FDA determined that it could not evaluate the adequacy of the response of Cardinal Health, Dublin, OH, to the 483 issued following its inspection, conducted April 10-15, "because you are still in the process of developing procedures for the...

Chattem fails to establish CAPA procedures.(Medical devices)
July 1, 2008... FDA inspected Chattem, Chattanooga, TN, which manufactures Icy Hot Heat Therapy Patches, Feb. 5-8 and found several violations of GMP requirements. The June 6 warning letter noted that the company failed to establish and maintain adequate...

CAPA deficiencies noted in Duro-Med Industries warning letter.(Medical devices)
July 1, 2008... During an inspection March 31-April 2 of Duro-Med Industries, Waukegan IL, of the firm's facility in Jesup, GA, FDA investigators noted that quality system deficiencies found in an earlier audit remained uncorrected. The firm, which...