How can you avoid GMP deviations?

It’s also of importance to have more than one validated source of material needed for the production, so a shortage in supply of a critical component, doesn’t lead to delay in your own production or decline in quality of final product.

One thing I have found that the cause of most deviation are the lack of required resources, improper training, not referring the procedure during performing the activities and lack of planning before execution.

Training your team is absolutely mission critical to avoiding deviations. My experience is that it takes a tremendous amount of time to properly train up a team, and that SOPs only get you part of the way there. Hands on training from experienced employees is worth its weight in gold, and is without question the most useful form of training. Unfortunately staffing shortages have become more and more common, and we need to look to modernize our approach. Augmented reality helps act like an additional hands on trainer, guiding staff through critical processes with automated instruction sets and enabling "phone a friend" on the shop floor. Additionally, an AR solution can help document deviations as they occur, speeding RCA to completion.

Sometimes, even great SOPs can be rendered useless if not written in the primary language of the personnel. I documented these observations on past EIRs that procedures were deficient because they were not written in the primary language for production personnel. EI interviews revealed that the lead production personnel verbally translated production SOPs to operators before production began. Once production started, operators were left on their own to recall the step-by-step production processes. Soon after the audit, the warehouse that stored finished drug products caught on fire because personnel did not understand the voltage charge between the plug and the socket.

Don't let your GMP deviation investigations end with SOPs and historical data and trends. Information from additional sources (instruction manuals, hardware vendors, peers) should be incorporated into a thorough investigation to ensure that each deviation provides as much area for improvement as possible. Machine learning can provide helpful insights into your investigation, allowing for aggregation of data from databases, optically scanned manuals and SOPs and historical deviation records. Synthesizing this data into knowledge and providing projected root cause analysis helps maximize the learning from each event.

We shouldn't avoid deviations; instead, we should have a system to prevent or to minimise the negative effects of the deviations.

Don't neglect your CAPAs! They're an essential part of the process, and an effective CAPA will save time and money for the entire organization. "Retrain operator" is obviously valid, but likely not sufficient to really address the root cause of a GMP deviation. Dig deeper and understand the process that led to the deviation - this will prevent the same deviation from occurring again and potentially tangentially related deviations to the original.