Formulation process with enhanced batch determination in ERP
Formulation in the Pharma industry is becoming increasingly complex and the industry must move to more robust ERP solutions to not only track the batches, but to determine the batches within the formulation process.
Batch determination is an important process in formulation, which involves determining different active and inactive ingredients, based on a set of complex rules. These ingredients are then combined to achieve the desired dosage of a final medicinal product. It is critical the process is 100% accurate and standardized to be able to select the correct active and inactive ingredient batches to produce a batch of a final medicinal product that is acceptable to the human body or even animals.
Although technology continues to advance at a rapid pace, the formulation process has not adapted or kept pace with these same advancements. It is common practice across the industry to find spreadsheets being used to calculate key formulas that will determine the required batches to be used within the formulation process. Some of the challenges of using this outdated process include:
- Complex macros built throughout the spreadsheet that have grown over many years and many users can easily become corrupted
- Information is being gathered from multiple systems to be manually input for calculation introducing great risk of user error
- Knowledge of the formulation process is restricted to just a few users due to the reluctance of new users to learn these complex macros and spreadsheets
To have the right tool to address the challenges within the formulation process, Tenthpin Management Consultants can help in building the custom solution within ERP. These tools will provide the ability to configure the complex formulation parameters for specific components that have predefined limits known as serial outlines. Serial outlines are established limits registered at the governing regulatory agency and contain certain critical parameters such as: potency to volume factors, ratio’s and percentages. These parameters are fundamental in controlling batch determination within the formulation process. The Tenthpin solution was a co-innovation with a large US pharmaceutical company and involved their industry leading business and IT experts. The innovative solution allows for maintaining formulation and potency requirements within ERP’s controlled environment. The specific ERP design utilizes an enhanced batch determination to select the appropriate batches to meet the registered requirements by utilizing common SAP functionality. The uniqueness of this innovative solution is the variable “physical to potency” relationship during batch determination allowing for optimization of “active ingredient” during formulation of variable API's. Performing ERP formulation reduces the process time by 75% compared to manual external formulation calculation.
Tenthpin Management Consultants are the right experts to help you build these tools to simplify your overall formulation processes.
Some of the key benefits that these tools include:
- Provide flexibility to choose only components that are relevant for formulation and maintain the required parameters as a one-time set up
- Batch determination proposals specific to stock status such as stock in quality inspection/reserved stock, etc.
- Use Planned Assay value for batch determination if actual assay value in the batch is still not available
- Use real time data in batch determination and the proposal of exact storage units/handling units
- Flexibility for the users to change the proposed batches
- Formulation sheets can be printed
- Elimination of spreadsheets with complex macros
Contact our industry experts at Tenthpin Management Consultants if you would like to learn more.