Validation Times articles from June 2004

Validation Times archives from June 2004

PAT not specifically mentioned in CPG to waive 3-batch validation if firms use 'advanced science,' engineering principles.(Process validation)
June 1, 2004... WASHINGTON -- FDA's new process validation compliance policy guide (CPG 7132c.08), which allows firms to defray validating three batches of drug product if they are using "advanced pharmaceutical science and engineering principles" does not...

September guidance seen forming basis of any Part 11 rewrite; firms urged to begin risk assessment now.(Electronic records)
June 1, 2004... ARLINGTON, VA -- FDA is likely to use the September final guidance on its electronic records/signature regulations (21 CFR Part 11) rather than do a large-scale revision of the 1997 roles, according to a U.K. consultant and former special...

FDA won't issue CMC guidance under GMP Initiative, may try to eliminate supplements, move to 'quality assessments'.(CMC)
June 1, 2004... WASHINGTON -- Center for Drugs decided earlier this month not to issue a final guidance on chemistry, manufacturing and controls (CMC) under the agency's GMP Initiative, but will instead embark on a major effort to reduce the number of...

USP to address TOC for PAT.(Water systems)
June 1, 2004... PHILADELPHIA -- The U.S. Pharmacopoeia's Pharmaceutical Water Expert Committee this fall plans to release changes to USP Chapter 643 with modified test methods for total organic carbon (TOC) in part to facilitate industry's transition to PAT,...

Companies want FDA to tell them what to do on Part 11; GAMP Council weighs in.(Electronic records)
June 1, 2004... ARLINGTON, VA -- Most comments from industry appear to support FDA's new risk-based approach and narrowed scope of Part 11, but some firms expressed confusion on what FDA plans to enforce. U.K. consultant Sion Wyn told ISPE here June 7: "The...

'Feed water' seen as new FDA target.(Water)
June 1, 2004... PHILADELPHIA -- Feed water appears to be a target for FDA inspectors as drug companies appear to be lagging other industries in monitoring their water systems, according to experts speaking here May 25-26. TC Soli, manager of SAP Project...

PAT produces operating efficiencies in bioprocessing at Lilly.(Process analytical technology)
June 1, 2004... ROCKVILLE, MD -- A lesser-known, more practical reason to use process analytical technology (PAT) in the production of a biotech APIs is to produce operating efficiency, a noted expert in PAT at Eli Lilly told a CDER seminar here June 2. ...

Nanjin Pharmaceutical cited for 2 validation flaws.(Human/animal drugs)
June 1, 2004... James McReavey and Kent Faul from Center for Veterinary Medicine served human and veterinary bulk API manufacturer Nanjing Pharmaceutical with a 483 for two validation citations regarding system suitability tests (SST) and testing production...

West Ward hit with 483 for investigation deficiencies.(Human/animal drugs)
June 1, 2004... Tablet and capsule manufacturer West Ward Pharmaceuticals, received a three-item 483 from Nancy Rolli of FDA's New Jersey District for not including laboratory investigations in annual product reviews, as well as invalidating...

Cytogen receives 483 for validation violations.(Biologics/medical devices)
June 1, 2004... An inspection of biopharmaceutical manufacturer Cytogen Corp. uncovered numerous validation deviations, including a lack of data to support hold times and a lack of container closure integrity studies. Ann Marie Montemurro with FDA's Office of...

Janssen's Belgium device plant comes up short on validation, testing.
June 1, 2004... Janssen's drug-eluting stent plant in Beerse, Belgium, received an eight-item 483 for deficiencies related to test-method validation, process-performance qualification, acceptance procedures, and corrective and preventative actions (CAPA),...

Drug manufacturer lacks essential quality control, production methods.(Human drugs)
June 1, 2004... Pharmaceutical Formulations, Edison, NJ, received a warning letter May 5 because it lacked an adequate QC unit with the responsibility and authority to approve or reject in-process materials and drag products, and thus prevent errors in...

Tri-Med cited for GMP deviations, lack of cleaning validation.(Human drugs)
June 1, 2004... An April 28 warning letter to Tri-Med Laboratories of Somerset, NJ, detailed significant GMP rule deviations, including failure to assure each drug product was free of objectionable microorganisms throughout their expiration dating periods. The...

Labeling, documentation, quality system problems cited.(Medical devices)
June 1, 2004... A warning letter was issued to Blind Industries and Services of Maryland, Baltimore, MD, on May 7 for regulatory problems involving the company's sterilization wraps--which are both manufactured and marketed by the firm. Significant deviations...

PET manufacturer not in conformance with GMP requirements.
June 1, 2004... Positron Corp., Houston, TX, a manufacturer of positron emission tomography (PET), diagnostic scanners,, received a warning letter on April 26 because it was not in conformance with the current GMP roles. Further, the firm had neither analyzed...

Surgilight cited for several validation violations.
June 1, 2004... FDA determined that Surgilight, Orlando, FL, manufacturer of the Optivision Laser System, was in violation of Quality System regulations in an inspection conducted from Jan. 12-26. Specifically, the company failed to identify, document,...

TGM cited for failure to establish Quality Systems procedures, instructions.
June 1, 2004... TGM Products, Farmingdale, NY, received a warning letter on May 3 because an FDA inspector determined the manufacturer of dental forceps, orthodontics pliers, clip forceps and cholangiography instruments, had failed to establish Quality System...

American Medical Specialties cited for failure to validate/approve processes.
June 1, 2004... A May 16 warning letter cited American Medical Specialties, Largo, FL, because the company failed to validate and approve processes whose results could not be fully verified by subsequent inspection and testing; failed to validate the sealing...

Manufacturer not in conformance with current GMP requirements.
June 1, 2004... Information collected during a Dec. 2-5, 2003, inspection resulted in a May 17 warning letter for Haemoscope Corp., Niles, IL, because the manufacturer of hemostasis analyzers was not in conformance with the current GMP roles. For example,...

GMP violations for blood bank lack of validation data.(Blood biologics)
June 1, 2004... An FDA inspector documented several GMP violations in a May 7 warning letter for Our Lady of the Lake Hospital, New Orleans, LA, including failure to perform a thorough investigation and make a record of the conclusions and follow-up of...

Hunterdon cited for validation violations.(Blood biologics)
June 1, 2004... Hunterdon Medical Center, Flemington, NJ, was cited in a May 3 warning letter for significant deviations from the current GMP regulations for Blood/Blood Components, including failure to maintain accurate records to identify unsuitable donors....