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Manufacturing change flows quickly to stay ahead of legislative change.
The automaker told the safety agency it made a manufacturing change in early November to correct the headlight problem.
Mariana Mack, a company spokeswoman, wrote in an e-mail that the appropriate manufacturing change was made by the seat supplier, Laredo, a Chinese company.
The company discovered that a minor manufacturing change in 1998 had created an interaction between the product and rubber stoppers used in syringes, causing the patients' reaction.
Steve Janisse, a Porsche spokesman, wrote in an e-mail that when the automaker made the manufacturing change in January, it had not concluded that there was a safety problem requiring a recall.
The objective of this paper is to provide a decision support for manufacturing change management and to enable a thorough analysis of changes in manufacturing systems.
Similar(45)
Current guidelines recommend manufacturers to assess the effects of manufacturing changes on identity, strength, quality, purity, and potency of a drug as they relate to the safety or effectiveness of a product.
The regulatory process for the approval of biosimilars was derived from the same scientific principles and experiences with comparability exercises that manufacturers of originator drugs have to perform when implementing manufacturing changes.
What happened was the cost of manufacturing changed".
Whether manufacturing changes had anything to do with the Sprint Fidelis problems remains to be proved.
"When you're talking about manufacturing changes, it's not something that going to happen overnight," he said.
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