Quality schedule types
Quality schedule types, which allow defining quality schedules for test groups, can be set up in Life Sciences Quality Control & Assurance > Setup > Quality order scheduling > Quality schedule types.
Quality schedule types can be used as part of the following processes:
Environmental control, if the Enable recurrence and Enable sampling point parameters are enabled.
Stability studies, if the Enable storage conditions parameter is enabled.
Time points
While a stability study or environmental monitoring project is ongoing, samples are pulled from a selected sampling point/location on a regular basis (that is, throughout different time points), and their integrity is assessed by conducting laboratory testing against an approved stability product or environmental control specification.
Time points can be set up in the Life Sciences Quality Control & Assurance > Setup > Quality order scheduling > Timepoints.
When a new time point is created, the following information can be manually entered:
Timepoint.
Description.
Quality schedule type.
Frequency period and Period for time points associated with quality schedule types with Enable storage condition enabled.
Margin days early and Margin days late are used to define an acceptable timeframe within which a scheduled activity can be executed.
Recurrence for time points associated with quality schedule type with Enable recurrence enabled – Used to define a time point as recurrent throughout an environmental control project (for example, every Friday).
Sampling points
The Quality Control department of pharmaceutical and chemical companies needs to ensure that proper tests are executed on the utilities consumed in manufacturing processes (for example, water, air). To meet this requirement, different sampling points must have a unique sampling point code to unequivocally identify where the samples are removed for environmental control inspections.
Sampling points can be set up in Life Sciences Quality Control & Assurance > Setup > Quality order scheduling > Sampling points.
When a new sampling point is created, the following information can be manually entered:
Sampling point.
Description.