Life is full of risks and we all know that failures happen every day not only in every drug-manufacturing department.
The question is not how many failures happen but how to avoid the same failures in the future. One of the key success procedures is the investigation process in a pharmaceutical company.
Important GMP regulations force an investigation process, thus every company has already implemented a procedure to do so. However, does this really have an impact on the recurrence of failures in the future? Are the investigations conducted in a productive way?
This article provides some recommendations for improving investigations with the final goal that recurrence of the same mistakes is eliminated or reduced.
Effective science-based investigations lead to error prevention, operational excellence and
patient safety. And it is an industry challenge to apply appropriate scientific rigor to investigations. As a GMP fundamental approach the investigation reports must be well documented. This seems to be an easy task. Nevertheless, I recommend taking a close look at your company’s recent investigation reports. Do you really understand the report? Is it written in a clear, precise way and without uncertainty?
I am sure you have already noticed the risks of an investigation report:
This happens, because the process is inadequately implemented, trained or followed. The goal should be to write the best investigations ever leading to a significant reduction of cost and effort.
Implementing an effective investigation procedure will have the following benefits:
This has been common practice in a lot of industry branches. The only way to reduce errors is to recognize them and to work on a preventive action program.
The U.S. FDA also realized that an effective CAPA system is critical[ii]. Important elements are:
The FDA also observes the following findings that are related to investigations:
But there are some factors and questions leading to better investigations:
One of the most crucial points of the list above - also from my industry & consulting experience - is the first one. Just imagine that the right people are not at the table. How would it be possible to support that all of the appropriate data is reviewed? Which in turn questions the validity of the assessment and identification of the cause/s. And finally, are you sure to implement and execute the appropriate corrective measures?
Try checking the following: Have the following necessary subject matter experts been involved in an investigation?[iii]:
Improvement of investigations is a long-term goal. You should consider the following points if it comes to investigations (excerpt):
Organize investigation teams
Develop and brief investigation plan
Evaluate HA[iv] notification
Draft CAPA recommendation
Drafting investigation report
Working with the Quality Management
Redesigning the investigation process is well worth the effort when it does not support the decrease of failures and investigations in a company. To change the common practice in the organization and use the investigations as a source of knowledge and improvements takes time. This transition is more than a quality topic. It should be part of a change process of quality management and should be supported by experienced and trained change experts. The implementation of an improvement oriented investigation process is a necessary step to a long-lasting improvement of quality in the pharmaceutical industry. It does not ensure to reach the goal but it is an absolutely necessary step.
Organizations that put in place meaningful failure investigations and processes for investigations will not only strengthen their business base but achieve sustainable improvements in their productivity and product quality.
[i] Martin VanTrieste, PDA/FDA Improving Investigations Workshop, Washington DC, 2013
[ii] Rick Friedmann, Associate Director, Office of Manufacturing and Product Quality, Office of Compliance, PDA/FDA Improving Investigations Workshop, Washington DC, 2013
[iii] Thomas Arista, Field Investigator, National Expert Pharmaceutical/Biotechnology, ORA, PDA/FDA Improving Investigations Workshop, Washington DC, 2013
[iv] HA = Health Authority
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