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Antonio Di Ruocco
Someone can correct this analysis?
The change has been assessed as Low Impact, according to Attachment 1 of TV-SOP-42925 v27.0 (GxP Change Control Management in the Pharm Segment) based on the following rationale:
• there is no impact to Regulatory Compliance since the change manages a Standardization of the label of cleaning samples
• there is no impact to Quality since there is no impact to critical process parameters and/or critical material attributes of drug substance or drug product;
• there is no impact to EH&S as no EHS relevant activities will be performed as result of this change control
Implementation Strategy
In order to add the sampling activities and the related Chemical and microbiologic analyses to the present cleaning program, a documental update will be performed to align all the impacted procedures. The aim of my project is to standardize the label for cleaning sample through the eLims system.The aim is to update the eLIMS Master Data by introducing an EMS Group of Cleaning Validation, such as to be able to generate SampleID by obtaining information from the EMS group.
The execution of the sampling and the recording of the reception of the samples will be managed in Elims in the Sampling and Receiving section.
This project aims to standardize label and sampling flow.
28. Nov. 2023 18:02
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Antonio Di Ruocco
Sprachfähigkeiten
Englisch, Italienisch, Spanisch
Lernsprache
Englisch, Spanisch
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