Life Sciences

Generic Pharma R&D departments of Life sciences companies suffer perennial mismatch between capacity and load. This becomes more evident towards the end of second and fourth quarters of the year. Critical resources are extremely busy during these months.. In the first part of the year, the resources have to complete Exhibit Batch related tasks. At the end of the year, they have to attend to submission requirements followed by a spate of FDA queries. All these ‘urgent’ tasks have to be addressed by the same set of resources which are stretched beyond capacity. This is a problem that pharmaceutical companies have been unable to solve with traditional project management tools.

Vector Consulting uses principles of flow management to help pharma companies complete R&D projects at significantly lower lead times (without increase investment in resources).

International warehouses for generic pharmaceuticals, whether owned by a Life science company or maintained by a distribution partner in that country, need to maintain adequate stock so they (the warehouses) can meet the varying local demand and can offset the highly varying lead times of manufacturing and supply. This is a tightrope walk for them. Fear of sales loss and the heavy penalties on unavailability imposed by some countries force these warehouses to hold significantly high levels of pharmaceutical inventory. However, stocking too much inventory comes with the risk of much of these reaching near or crossing the expiration date. The distribution channel will be very reluctant to accept pharmaceutical stock nearing expiry. If the pharmaceuticals’ expiration date is crossed, the warehouse will have to destroy it!

Life science companies engaged in the manufacturing of generic pharmaceuticals can solve the ‘too much or too little’ conundrum by ensuring that their international warehouses have 100% availability at low inventory. Find out how with its expertise in harmonizing supply chain operations, Vector Consulting can help companies achieve this.

Quality Control Laboratory (QC Lab) serves one of the important functions in pharmaceutical production and control. Quality tests are numerous, varied, stringent and time-consuming. Therefore, in order to ensure that manufacturing goes on unhindered, the QC Lab must perform all the required tests, right from raw material, in-process & finished goods efficiently, while also ensuring compliance as per regulatory guidelines. However, despite careful planning, a high frequency of occurrence of OOS (Out Of Specification, i.e., breach of the allowed upper/ lower limit of the parameters of drug testing), especially invalid OOS cases (breach not due to the drug itself, but because of the lab testing or manufacturing processes) and lab incidents (process deviation) plague this department, raising doubts about the robustness of testing/ manufacturing with the auditing agencies.

Some of the typical solutions companies tend to take to solve these issues are to increase the level of supervision in the lab, to put the analysts through more training, and to add resources to reduce load on the system. However, these steps, while offering some improvement, do not sustain, or the benefits stagnate after a point.

The key to sustained and continuous improvement in quality departments is to first address the cognitive overload in the system with the objective of bringing down manual errors (Type A) to minimal levels. Then the systemic errors (Type B) due to incorrect method followed, unclear procedure, etc. will become visible, and actions can be taken to rectify them.