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3M receives 2-item 483; cleaning validation problems noted in EIR.(Human drugs)
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 transdermal patches. Investigator Kari Johansen from FDA's Irvine, CA, District Office, performed the inspection.
According to the EIR, Johansen reviewed cleaning validation procedures with the firm's product team lead. The document states: "I reviewed the QVAR Cleaning Validation Protocol and Report from December 1998, covering all the equipment used to manufacture QVAR. The rationale for allowable residues and cleaning components was documented, but the firm did not explain the equipment swab sampling points or describe the exact location."
The employee said he swabbed the worst-case points within the equipment, "which was determined by the engineers performing the cleaning validation," the FIR stated. "[The employee] said they were different in that the engineers, who knew the equipment best, were the same people who performed the cleaning validation."
Johansen also reviewed the firm's micronizer table. "The summary report showed that the micronizer table exceeded the allowable residual level," the FIR noted. "The firm's report considered the validation acceptable because the table was not considered in product contact," the FIR noted.
Another employee added that the table ...
- FDA objects to company's revised Process Validation Protocol.(Medical Devices)
- Newspaper article from: Validation Times December 1, 2003 700+ words
...agency acknowledged the company's revised Cleaning Validation protocol, but noted the FDA investigator stated in his initial report that he was informed this cleaning validation protocol was initially prepared in April 2000 but never...
- Cleaning validation needs to be broader, Perrigo told.(a pre-approval...
- Newspaper article from: Validation Times April 1, 1999 700+ words
...chlorine. However, the validation protocol did not address this...suggested "expanding cleaning validation" to address the time lapse. Cleaning validation also was in progress...Detroit District * Cleaning validation
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- Newspaper article from: Validation Times Pickett, Joseph October 1, 2006 700+ words
...WASHINGTON -- When it comes to cleaning validation, FDA expects companies...The first step in the cleaning validation process, she stated...be "tied in with the cleaning validation policy, or master validation...the preparation of the validation protocol, it is ...
- Taking stock of cleaning process validation: productive cleaning validation...
- Magazine article from: CleanRooms Kanegsberg, Barbara Kanegsberg, Ed January 1, 2009 700+ words
...products. The important steps in a cleaning validation program vary depending on the type...process means that prior to setting up cleaning validation, the cleaning agents, cleaning...must be cross-referenced in the validation protocol. Defining and optimizing the cleaning...
- Firms can give FDA validation protocol to avoid 3-lot hassles. (Process...
- Newspaper article from: Validation Times Regier, Hilda May 1, 2000 700+ words
...of water you're going to be using, what type of controls have you validated from a micro perspective." The cleaning validation, she noted, will also be reviewed. For parenterals, Rolli reported, investigators will check for raw material...
- Maximize the value of your cleaning validation program through holistic project...
- Newspaper article from: Validation Times DiFelice, Andy Stock, Chuck November 1, 2007 700+ words
...project manager responsible for cleaning validation can develop a program with a positive...reaches beyond compliance with GMPs. Cleaning validation is a process validation based on...develop and manage a successful cleaning validation project and addresses the business...
- Cleaning validation expected to be complete by year's end, patched screens...
- Newspaper article from: Validation Times Witkowski, Wallace July 1, 2002 700+ words
Cleaning validation residual studies at active pharmaceutical...estimated completion dates for cleaning validation residual studies in response...which characterized the firm's cleaning validation to be "limited to only glassware...
- How to deal with cleaning and contract manufacturers.(excepts of speech given...
- Newspaper article from: Validation Times January 1, 2002 700+ words
...fast change artist, working on the cleaning validation team in a contract manufacturing...million," said Ann Johnson, senior cleaning validation specialist, Diosynth RTP., Research...Park, NC, speaking at Barnett's cleaning validation meeting. Many of the contract manufacturer...
- Taro slapped with 24-item 483, citing cleaning validation and verification...
- Newspaper article from: Inspection Monitor March 1, 2006 700+ words
...Bay, Israel. CDER Questionable cleaning validation and verification testing practices...many of the API plants lacked cleaning validation for the production equipment, FDA...in Chemical Plant" defined the cleaning validation/verification of process equipment...
- Fontarome Chemical receives clean report, but packing and cleaning validation...
- Newspaper article from: Validation Times Pickett, Joseph May 1, 2005 700+ words
...about its packaging operations, cleaning validation and water system validation. Investigator...endotoxins," the FIR stated. Regarding cleaning validation, the FIR noted "since the previous...significant progress in developing a cleaning validation program. The firm divided the ...
Source: HighBeam Research, 3M receives 2-item 483; cleaning validation problems noted in...