The Pharma Consumables Conundrum: How Agentic AI Consumables Manager Solves It
Some challenges confronting project businesses are so dramatically multidimensional that they seemed to be impossible to tackle until the arrival of Agentic AI technology.? In the previous edition, we discussed how PSA’s Agentic AI Skills Manager can solve one such problem - Managing hundreds of skills of thousands of employees.???
It is good to know that Agentic AI isn’t an overkill for simpler problems. One such problem confronts the Pharma industry - the consumables used in the formulations and analytical departments.
One usually attributes delays in launching new drugs with complex technical difficulties, clinical trials, or regulatory hurdles. While these remain the main causes, it may surprise you that much simpler problems like the consumables conundrum can also delay launches of new generics and increase costs.
The consumables issue stays below the radar until it is examined.
Agentic AI makes a solid business case in the Pharma industry’s NPD(New Product Development) projects.
Invisible stocks of expensive consumables delay drug launches.
During development of new drugs, analytical labs use chromatography columns in High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), and Ultra-High-Performance Liquid Chromatography (UHPLC) machines to precisely quantify the constituents of drug samples. You need them to verify that the samples of new formulations have exactly the same amount of ingredients as intended.?
A column segregates the constituents of the sample to determine the quantity of each component. For example, if a sample must contain 5mg of one component and 2mg of another, the testing column helps verify these quantities.
Formulation departments use punches to form tablets and to mark their dosage strengths. The punches’ face geometry( e.g radius of edges, flatness), type of material, and usage cycles significantly impact the quality of formulations.?
Columns and punches are high tech items. Their construction, ingredients, and quality have a huge impact on the quality of drug development and regulatory compliance.
Columns and punches are considered as consumables - they can be reused a limited number of times. But they are expensive - their costs in the Indian market range from Rs 10,000 to Rs 1,50,000. These high tech items need long lead times to procure.
The above consumables are issued to the user departments for use during drug development. Once issued, the ERP system shows that the stocks have been consumed. The issued items sit in the user departments. User departments manually record their stocks in spreadsheets. When a scientist puts in a requisition for a specific column, the ERP system initiates its procurement if it is not in inventory, while the required column is available somewhere in the company.?
Delays, costs, regulatory risks
If some consumables aren’t available, users in analytics and formulation departments must wait for them to be available. As a result, a drug development project gets delayed. At the same time the company spends additional cash to procure a column or a punch even if it is available within the company but is outside its ERP!
Each high tech column is accompanied by the manufacturer's printed test certificate mentioning its serial number, number of re-uses permitted and other technical details. The analytical department must mention the column serial number etc. in its test reports to be submitted as a part of the dossier for regulatory approval. Any problems in establishing traceability of columns and punches used can lead to delays in approval of the new drug.
Similar issues crop up in case of punches. They also have serial numbers and test certificates.
My recent interactions with industry confirm that the columns and punches problem is widely prevalent in the Pharma sector.
The solution
The reach of an ERP system is limited to receipts and issues of various items. Expensive consumables pose a challenge because the digitization of NPD projects is incomplete because their stocks in user departments are invisible. Modern PSA makes them visible..?
A modern PSA provides a column master and a punch master through its customisable repositories.? The repositories keep records of all the attributes of columns and punches. For example, the column master keeps track of serial numbers, types, and reuse limits.?
The PSA also maintains a department-wise inventory of the consumables. When an item is issued from the ERP’s inventory, PSA adds it to the respective department’s inventory. Whenever a scientist places a requisition of a column for testing a formulation, PSA checks the department's inventory before releasing a purchase requisition coming from ERP. If the required column is available in the department’s inventory, PSA issues it to the user and updates the inventory.?
The PSA keeps track of the manufacturer’s serial number, the test certificate details, and the internal item code. It also tracks the number of reuses of a particular item and makes it available at the time of preparing the drug’s dossier to establish their traceability.??
A modern PSA thus extends the NPD project digitization to cover the above critical operational need.?
Proactive Agentic AI Consumables Manager
Agentic AI uses operational data like inventories (in ERP and departments), serial numbers, number usage cycles, etc, that the PSA maintains.?
Conclusion
Agentic AI Consumables Manager operates on the foundation of end-to-end digitization of Pharma NPD projects provided by a modern PSA. It enables timely ordering of expensive consumables and prevents delays in drug NPD projects. It prevents their stockouts. It conserves NPD budgets by avoiding unnecessary ordering of expensive items. Agentic AI Consumables Manager tracks serial numbers, test certificates, and usage cycles of columns and punches and establishes their traceability for a new drug’s regulatory filing.?
Kytes, an advanced PSA software, provides autonomous Agentic AI managers to help you overcome business challenges -whether they appear to be very complex or whether their simplicity hides their negative impact.
Please contact us at [email protected] for more information or for a demo.