A large generic drug manufacturing company - Quality labs

One of the largest generic drug manufacturers in the world, was facing a slow-down in their new product approvals. The high frequency of occurrences of OOS (out of specification- i.e. breach of drug testing parameter’s allowed upper/lower limit), especially invalid OOS (breach not due to the drug itself but because of the lab testing) cases and lab incidents (process deviation) was raising doubt on robustness of testing with the auditing agencies.

Evidently, like everyone else in the Industry, this company too was continuously trying to solve these issues and improve continuously. Some of the typical solutions companies tend to take 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, experience had shown management of this firm that these steps, while offering some improvement, did not have a sustained positive effect on parameters of interest. After a while, any improvement that accrued, stagnated. Thus, in order to achieve sustainable jump in performance, the company undertook a closer study of the testing environment with the help of Vector.

This study indicated that the analysts could be under a situation of significant cognitive overload. The analysts have the responsibility to

• Conduct all activities of assigned tests as per the TDS(test data sheet) – i.e. collect glassware, documents, arrange for chemicals and reagents, ensure validity of all solutions prepared till tests are complete, select appropriate equipment(e.g., column), manage instruments, etc.
• Generate audit trail for which they also have to record the equipment used.
• Concurrently record various observations in TDS and maintain a separate checklist to ensure no steps are missed.

All these, the analysts have to manage in an eight hour shift by switching between various stages of testing (Instrument setting/monitoring, solution preparation, mobile phase, collecting glassware, checking/arranging resources, etc.) and by trying to take advantage of the natural waiting time in some of these stages. Unfortunately, the human brain finds such a balancing act and this level of multi-tasking very difficult to manage. Therefore, occurrences of inadvertent skips and misses became inevitable.

In addition to such human errors, testing environments also tend to have systemic errors due to

• Missing information in the STP/TDS or because of inadequately documented STP/TDS.
• Process gap or due to gap in testing method

However, when faced with a melee of different kinds of errors occurring, it was difficult for managers to infer and assign real causality for these errors. This confusion was leading to frequent finger pointing, stress and inability to take timely corrective actions.

Based on these insights, the company with the help of Vector, could clearly define the direction of solution. They realized that the only option was to first address the cognitive overload in the system to bring down manual errors to minimal levels. Then the systemic errors due to incorrect method followed, unclear procedure, etc, will become visible and actions can be taken to rectify them. This was a revolutionary new approach hitherto not applied in the pharma industry helped the company in significantly reduce invalid OOS and bring down lab incidents.

Some salient details of the results of the implementation are as below: