Validation Times articles from November 2003

Validation Times archives from November 2003

USP may adopt chapter on ancillary product validation; is USP helping 'generic biologics'?(Biologics/biotech)
November 1, 2003... ARLINGTON, VA -- The U.S. Pharmacopeia (USP) in March is expected to published an "informational chapter" for public comment on how firms can validate ancillary products used in biotech drug processing, including media and animal-derived...

Industry concerned how comparability protocols will work with changes.(CMC)
November 1, 2003... VIENNA, VA -- The risk in process changes is not what is known but rather what is not known. The trouble with most comparability protocols is that they are based on what companies think they do know and they fall down on what they don't know in...

Chiron exec advises using device GMPs as guide for assessing product risk, mitigation.(Development reports/risk)
November 1, 2003... VIENNA, VA -- As FDA pushes the pharmaceutical industry to adopt process analytical technology (PAT) and use "development reports" as a means of keeping the agency apprised of process changes, some companies are finding the medical device...

Documenting validation key to demonstrate comparability.(Methods/validation)
November 1, 2003... VIENNA, VA -- When demonstrating comparability, manufacturers need to think in terms of their own IND development and how each change affects the process. Conducting pre-approval comparability studies can accelerate the application review and...

Demonstrating lack of impact on safety, efficacy key in protocols, consultant says.(Comparability protocols)
November 1, 2003... To understand the regulatory requirements for comparability, manufacturers must think like regulators, suggested Elizabeth Leininger, Ph.D., senior consultant, Biologics Consulting Group, Fremont CA, during the IBC Life Sciences conference in...

FDA could second-guess ranking of CAPAs, expert says.(CAPAs)
November 1, 2003... FDA inspectors could question why a manufacturer initiated corrective and preventive action (CAPA) on one failure while ignoring others, though there have not been any warning letters on this just yet. But Paula Shadle, Ph.D., of Shadle...

Despite variability, FDAer says bioassay still needed in validation; USP to revise Chapter 111.(Bioassays)
November 1, 2003... ARLINGTON, VA -- Although bioassays are not perfect and tests do vary, having one is necessary to characterize biotech products, a Center for Drugs official said Nov. 21. Addressing the USP's conference on biotechnology and biologics,...

Lilly receives nine-item 483 for validation deficiencies, SOP deviations.(Human drugs)
November 1, 2003... Patricia Cochran and Dennis Guilfoyle of FDA's Detroit District discovered validation deficiencies, SOP deviations, insufficient sterility testing and training deficiencies at Eli Lilly's Indianapolis parenteral manufacturing plant. The...

Merck falls short on aseptic failure investigations; receives 54-item 483.(Human drugs)
November 1, 2003... Merck's West Point, PA-based Vaccine and Sterile Operations Division received a 54-item, 22-page 483 for failing to investigate deviations to determine root causes of aseptic processing failures. FDA's Philadelphia District dispatched a team...

Zenith cited for production, quality system issues.(Human drugs)
November 1, 2003... Generic drug manufacturer Zenith Laboratories Caribe (ZLC), Cidra, Puerto Rico, received a 10-item 483 for serious production and quality system deficiencies that included change control processes, NDA field alert reporting, manufacturing...

Device manufacturer fails to analyze failures, identify corrective actions.(Medical devices)
November 1, 2003... Medical device manufacturer MDS Nordion, Kanata, Ontario, Canada, received a 483 for numerous quality system and GMP deficiencies, including failure to validate computer numerically controlled (CNC) lathes and software, failure to analyze...

Nutra Med fails to implement adequate testing, validation program.(Human drugs)
November 1, 2003... Nutra Med, Rahway, NJ, received a warning letter Oct. 2 for cleaning validation and modifications to a USP dissolution test method, among other GMP citations. The letter also cited the company, inspected Jan. 6-17 by the New Jersey...

Organon releases Zemuron Injection adulterated with metal fragments.(Human drugs)
November 1, 2003... Organon USA's drug manufacturing plant in West Orange, NJ, was cited in a Sept. 29 warning letter for a variety of filling problems, metal fragments found in an injectable drug as well as equipment validation, following an April 24 through June...

PLIVA neglects to investigate OOS lab results.(Human drugs)
November 1, 2003... PLIVA, East Hanover, NJ, was cited in a warning letter for significant deficiencies in the QC lab including out-of-specification (OOS) results that were invalidated without a thorough investigation, supporting data, documentation or...

MedPACS' design process procedures not in conformance with QS rules.(Medical devices)
November 1, 2003... MedPACS Displays, Hartland, WI, was cited in an Oct. 9 warning letter for design controls violations, including verification and validation involving its WinPACS Display Systems, which are picture archiving devices. Following a Sept. 10-12...

Fluoroscopy equipment manufacturer lacks quality policies, MDR procedures.(Medical devices)
November 1, 2003... Cares Built, Keyport, NJ--a manufacturer of remote switches for portable X-Ray machines, which acts as its own-label distributor for radiography and fluoroscopy equipment--had failed to establish a quality policy and did not have a QS...

Consolidated Machine's software change in sterilizer draws letter.(Medical devices)
November 1, 2003... Consolidated Machine Corp., Boston, failed to submit a 510(k) for software changes with its steam sterilizers, nor validate its processes, FDA said in a Sept. 24 warning letter. The key issue cited by the New England District, which...

Con-Cise Lens cited for failing to validate software used in producing lenses.(Medical devices)
November 1, 2003... Con-Cise Lens Co., San Leandro, CA, was cited in a warning letter for failing to validate the software used in making rigid, gas-permeable contact lenses, among other violations of device GMP/QS rules. According to the Sept. 19 letter,...

CAPAs, QS faults plague drugs-of-abuse test kit maker.(Medical devices)
November 1, 2003... Failure to provide supporting documentation for corrective and preventive actions (CAPA), along with general QS regulation violations, were key findings in a recent warning letter to Drug Free Enterprises (DFE), Agoura Hills, CA. According...

Medi-Stat fails to document cleaning validation.(Medical devices)
November 1, 2003... Medi-Stat, Littleton, CO, got a warning letter for failure to document cleaning validation involving its single-use, pulse oximeter sensor devices, along with citations for design controls violations. Denver District Investigator Nicholas...

Tri-State Analytical Lab cited for OOS, inadequate SOPs.(Blood/biologics)
November 1, 2003... A July 23-25 inspection by New Orleans District investigators at Tri-State Analytical Lab's, Johnson City, TN, microbiology laboratory revealed several GMP violations, including reporting that OOS analytical results met specifications. The...