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- Cleaning_validation abstract "Cleaning validation is the methodology used to assure that a cleaning process removes residues of the active pharmaceutical ingredients of the product manufactured in a piece of equipment, the cleaning aids utilized in the cleaning process and the microbial attributes. All residues are removed to predetermined levels to ensure the quality of the next product manufactured is not compromised by waste from the previous product and the quality of future products using the equipment, to prevent cross-contamination and as a GMP requirement. The FDA has strict regulation about the cleaning validation. For example, FDA requires firms to have written general procedures on how cleaning processes will be validated. Also, FDA expects the general validation procedures to address who is responsible for performing and approving the validation study, the acceptance criteria, and when revalidation will be required. FDA also require firms to conduct the validation studies in accordance with the protocols and to document the results of studies.The valuation of cleaning validation is also regulated strictly, which usually mainly covers the aspects of equipment design,cleaning process written, analytical methods and sampling. Each of these processes has their related strict rules and requirements. Regarding to the establishment of limits, FDA does not intend to set acceptance specifications or methods for determining whether a cleaning process is validated. But some limits that have been mentioned by industry include analytical detection levels such as 10 PPM, biological activity levels such as 1/1000 of the normal therapeutic dose and organoleptic levels.".
- Cleaning_validation wikiPageID "8301902".
- Cleaning_validation wikiPageRevisionID "593090805".
- Cleaning_validation hasPhotoCollection Cleaning_validation.
- Cleaning_validation subject Category:Quality.
- Cleaning_validation comment "Cleaning validation is the methodology used to assure that a cleaning process removes residues of the active pharmaceutical ingredients of the product manufactured in a piece of equipment, the cleaning aids utilized in the cleaning process and the microbial attributes.".
- Cleaning_validation label "Cleaning validation".
- Cleaning_validation label "تحقق من تنظيف".
- Cleaning_validation sameAs m.026zmw9.
- Cleaning_validation sameAs Q5130576.
- Cleaning_validation sameAs Q5130576.
- Cleaning_validation wasDerivedFrom Cleaning_validation?oldid=593090805.
- Cleaning_validation isPrimaryTopicOf Cleaning_validation.