The sample quantity can be configured in different ways in the Item sampling form (Life Sciences Quality Control & Assurance > Setup > Quality control > Item sampling):
If the Quantity specification field is set to Fixed unit, the sample quantity required by the system will be equal to the quantity defined in the Value field.
If the Quantity specification field is set to Percent, the sample quantity will be calculated as a percentage of the received/manufactured quantity.
If the Quantity specification field is set to Advanced, the Advanced button is enabled. By clicking the Advanced button, authorized users can access the Advanced item sampling form, where they can define the sample quantity by analysis type. In the Advanced item sampling form:
The Sampling quantity on the header indicates the total quantity to be sampled. The total sample quantity can vary based on the total quantity received/produced or the number of sub-batches to be sampled.
The Sampling quantity in lines indicates the quantity to be sampled by analysis type (for example, 1 unit for physical and chemical analysis, 1 unit for microbiological analysis).
The Advanced item sampling is defined by filling in the following information:
Header:
Sub batches to sample: the user can specify the number of sub-batches to sample.
Total quantity: the user can define the minimum total quantity required for the selected sampling.
Sampling quantity: the user can define the sampling quantity.
Sample unit: sample unit inherited from the Sample unit specified in the Item sampling
Lines: multiple advanced item sampling lines can be created, following the order defined by the Line number:
Line number: automatically populated with sequential numbering.
Analysis type: the user can select the analysis type of the sample within the values defined in the Analysis types form (Life Sciences Quality Control & Assurance > Setup > Quality control > Analysis types). It is possible to divide the quantity for the same analysis type into multiple lines (that is, smaller samples) identified by different line numbers.
Sampling quantity: the user can define the sampling quantity of the sample.
Sample unit: sample unit inherited from the Sample unit specified in the Item sampling.
Sub batch type: the user can select the sub batch type to identify the type of sample (for example, Retention, Identification) within the values defined in the Sub batch type form (Life Sciences Quality Control & Assurance > Setup > Sub batch > Sub batch types).
Example
Item sampling setup:
The sub-batch sampling is set to sample all sub-batches.
The advanced item sampling is set to:
200 units (that is, 100 for microbiological testing and 100 for physicochemical testing) if 10 or less sub-batches are sampled.
400 units (that is, 200 for microbiological testing and 200 for physicochemical testing) if more than 10 sub-batches are sampled.
Scenario #1:
Four sub-batches of GMP material are received;
A quality order is automatically generated when registering the quantity. The number of sub-batches to be sampled and the quantities by lab/analysis type are calculated.
The quality order shows a quantity of 200 units; the number of sub-batches to be sampled is 4.
The item sampling inquiry shows that 100 units are needed for microbiological testing, 100 for chemical testing.
When lab analysts enter test results, the sample quantity for microbiological tests (for example, Bacteria) and for physicochemical tests are respectively 100.
Scenario #2:
Twelve sub-batches of GMP material are received.
A quality order is automatically generated when registering the quantity. The number of sub-batches to be sampled and the quantities by lab/analysis type are calculated.
The quality order shows a quantity of 400 units; the number of sub-batches to be sampled is 12.
The item sampling inquiry shows that 200 units are needed for microbiological testing, 200 for chemical testing.
When lab analysts enter test results, the sample quantity for microbiological tests (for example, Bacteria) and for physicochemical tests are respectively 200.