When managing raw materials used in the manufacturing of biopharmaceutical products, materials can be scheduled for full or reduced testing, allowing you to specify a frequency and duration so you can periodically run full testing on incoming materials, but apply a reduced testing approach to interim batches.
By designating who your approved material suppliers are, and whether the supplier has been qualified for reduced testing, Vault LIMS can automatically monitor the number of incoming batches and the elapsed time since the last full testing and assign the appropriate samples and tests. In the event of a supplier, process, or policy change, you can force full testing whenever necessary.
Setting Up Reduced Testing in Vault LIMS
You can define reduced testing options in Vault LIMS via field values at the Material-Organization (Supplier) join object, Lab Protocol, Lab Method, or Lab Sample Definition level, and the system applies the options when creating a new Batch of the applicable Material:
- Material-Organization (Supplier):
- Apply Reduced Testing: Selecting this checkbox marks the supplier as approved for reduced testing options for the related material. This is required for any additional logic to activate upon creation of a Batch record.
- Force Full Testing Next Batch: Selecting this checkbox causes Vault to override any other applicable rules and apply full testing to the next created Batch of the applicable material.
- Vault automatically populates and updates the Batch Count Since Full Testing and Last Full Test Batch fields as Batches of the material are created.
- Lab Protocol:
- Reduced Testing Frequency: The number of batches after which full testing should occur. For example, a value of 6 in this field indicates that Vault should apply full testing to every sixth created batch.
- Reduced Testing Interval (Months): The number of months since the last fully tested batch after which the next batch created should have full testing applied.
- Lab Sample Definition and Lab Method:
- Include in Reduced Testing: Selecting or deselecting this checkbox determines whether Vault LIMS will include or exclude the tests for a newly created batch that is eligible for reduced testing. Defining this option at the Lab Method level allows finer control, allowing for inclusion or exclusion of individual tests.
Combinations of these options allow for a variety of reduced testing strategies to be employed. When a new Batch record is created from a Supplier with Apply Reduced Testing selected, Vault LIMS evaluates the configured testing rules for each level and registers the appropriate samples and tests.
Example Testing Strategies
The below examples detail options that enable common reduced testing strategy options. For any of these options to take effect, the applicable Material-Organization (Supplier) record must have the Apply Reduced Testing checkbox selected.
In reduced testing or skip-lot testing an organization performs full testing once a specified number of batches are received from a supplier, and test batches in the interim with a limited set of tests, typically a subset of full testing. A reduced testing strategy typically includes the use of the Reduced Testing Frequency or Reduced Testing Interval (Months) options in combination with defining a subset of Lab Methods as Include in Reduced Testing within the applicable Lab Protocol.
In annual testing, an organization performs full testing or additional testing on an annual basis. An annual testing strategy typically includes the use of the Reduced Testing Internal (Months) option, with the interval set to twelve (12) months to ensure that full testing occurs every year.
In qualification testing, an organization performs full testing on a specified number of batches, or for a defined period of time, from a new supplier until the supplier’s material consistency has been adequately demonstrated. In this case, the reduced testing flag would be disabled until the supplier has been fully qualified.
To set up and work with testing strategies in Vault LIMS, a user must have a security profile or role which grants them Read and Edit permissions for the following objects:
- Organization (Supplier)
- Material-Organization (Supplier) join object
- Lab Method
- Lab Protocol
- Lab Sample Definition