Stability study

Pharmaceutical and chemical companies are required to manage physical samples to monitor the stability of materials. This process allows evaluating whether the product’s desired or guaranteed life expectancy conforms to the predefined recommendations for storage. This is achieved by pulling samples from different conditions and at different time points, which are then tested according to predefined inspection plans (i.e., stability protocol).

Life Sciences Quality Control & Assurance allows to:

1. Manage stability studies by integrating with the Project Management and Accounting module to trace the full timeline of stability protocols, including planning and execution of the stability study. A stability project may consist of multiple levels:

   1. Header project corresponding to the sales order/contract with the customer;

   2. Sub-projects for each product for which a stability protocol is in place;

   3. Sub-sub-projects for each stability protocol for a product.

2. Define a stability schedule with the list of tests to be executed at each time point for each storage condition, which is part of the stability protocol.

3. Configure quality associations to automatically generate quality orders against the stability study project.

4. Create quality orders according to the quality associations defined above.

Stability schedule

Stability schedules are set up in Life Sciences Quality Control & Assurance > Setup > Quality control > Test groups by creating test groups that must include:

• The full list of tests that will be executed during the entire stability study;

• A quality schedule defining the list of tests to be executed for the storage condition/time point combinations.

Stability project

A multi-level project structure for stability studies can be set up in Project management and accounting > Projects > All projects. For any sub-project or sub-sub-project, it is possible to specify the associated storage condition in the Storage condition field.

The storage condition set by the user at (any) project level is inherited in the Item requirements form whenever creating new lines to identify the material to be consumed during the execution of the stability study. If the storage condition at the project level is blank, it is possible to specify the storage condition directly in the Item requirements form.

A possible project structure for stability studies is the following:

• Project header PROJ001: Stability study

  • Sub-project PROJ001-001: Candidate (Item A)

    • Sub-sub-project PROJ001-001-001: Stability protocol for storage condition “SC01”

      • Item requirements: Item A, Site, Warehouse, Batch

    • Sub-sub-project PROJ001-001-002: Stability protocol for storage condition “SC02”

      • Item requirements: Item A, Site, Warehouse, Batch

STAEDEAN Life Sciences projects for stability studies leverage standard Microsoft Dynamics 365 Finance & Supply Chain Management Project Management and Accounting functionalities.

Stability schedule generation

Item requirements can be created for the samples to be tested.

For each item requirement line, it is possible to:

1. Create planned quality orders by clicking the Planned quality orders button. The scheduling date (i.e., the start date for the generation of planned quality order for the stability study) must be entered;

   Note

   To support project management activities, the system provides the capability to create a project work breakdown structure (WBS), including the list of stability quality orders with relevant start and end date information. The WBS can be easily exported to Microsoft Project by ticking the Transfer to WBS checkbox. For the WBS to be correctly populated, it is necessary to define a Default project category in Life Sciences Quality Control & Assurance > Life Sciences Quality Control & Assurance parameters > General tab. The transaction type for the project category must be “Hour”.

2. Review and approve the planned quality orders by clicking the Create quality orders button. Once this is done, quality orders for the stability study are generated and displayed in the list of quality orders in Life Sciences Quality Control & Assurance > Quality management > Quality orders.

Example

Company Contoso would like to manage Stability Studies within the ERP system.

Storage condition variables are set as follows:

1. “Temp – Temperature”

2. “Hum – Humidity”

Storage condition “SC01” has been created and approved as follows:

Warehouse “11” has a Storage condition set to “SC01”, approved and activated.

Quality schedule type “STA” is configured with Enable storage condition set to “Yes”.

The following time points are defined in the Time points form:

Tests are set as follows:

Test group “Long-term condition”, including all tests listed above, has the Quality schedule checkbox ticked, and the Quality schedule is configured as follows:

A quality association is set as follows:

• Reference type: ” Project”

• Item: “Sodium Hydroxide”

• Test group: “Long-term condition”

A project structure is set up as follows:

• PROJ001: Stability Study

  • PROJ001-001: Sodium Hydroxide

    • PROJ001-001-001: Long-term conditions, Temperature 25±2°C & Relative Humidity 40±5% RH
      Storage conditions: “SC01”

      • Item requirement: Item Sodium Hydroxide, Site 1, Warehouse 11, Batch 00006

      • Item requirement: Item Sodium Hydroxide, Site 1, Warehouse 11, Batch 00007

      • Item requirement: Item Sodium Hydroxide, Site 1, Warehouse 11, Batch 00008

Batches “00006”, “00007” and “00008” have storage conditions set to “SC01” and have on-hand available in a warehouse/location approved for storage condition “SC01”.

For each item requirement line, the user can create quality orders for each storage condition/time point combination set in the stability schedule.

Planned quality orders for the first item requirement line and scheduling date set to “1^st Jan. 2023″.