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Article: Trending, training, root cause analysis and change control needed in cleaning studies.(Cleaning validation)
- Article from:
- Validation Times
- Article date:
- October 1, 2006
- Author:
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WASHINGTON -- When it comes to cleaning validation, FDA expects companies to have written procedures detailing the cleaning processed used for various pieces of equipment, and for how the procedures will be validated--pretty much the same level of controls required in regular validation of processes and equipment.
Also, the agency expects firms to keep on a continuous basis trending data analysis, training of personnel, failures investigated for root cause and change control.
This is according to Kathleen Stith, president of PharmAssist Analytical Laboratory in South New Berlin, NY.
Speaking at SOCMA's annual conference on GMPs here Oct. 4-5, ...