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article imageRisk assessment is central to making pharmaceuticals Special

By Tim Sandle     Jun 1, 2018 in Science
Portmarnock - The manufacture of pharmaceuticals, and an evaluation of microbial hazards, requires a scientific approach to risk assessment. This was the key message from the recent Pharmig meeting on Quality Risk Management.
The meeting was a mix of lectures and practical workshops, geared around case studies, looking at different risk assessment tools and approaches. These were designed to illustrate what the philosophy of Quality Risk Management is about, what regulatory agencies expect, and how this system of management practice can be reliably implemented.
Risk is a familiar concept to most people. People take risks all the time. Even the act of driving to work carries some risk. It is important to understand that in life no activity can ever be totally risk free. However, not all hazards are easy to spot and to assess the risk that each hazard presents is context specific. The only way this can be understood is through a risk management program, and through a set of tools that can help to evaluate each risk. Even with such systems in place, the effectiveness of any risk assessment is only as good as the data inputted into it and where sound scientific methods have been utilized.
Selection of microbiological culture media. Collecting samples can help to provide a basis for under...
Selection of microbiological culture media. Collecting samples can help to provide a basis for understanding risk.
To help pharmaceutical and healthcare manufactures, regulators of drug products developed an internationally agreed set of definitions and approaches, under the International Conference on Harmonization (ICH). Here ‘risk’ is defined as “the combination of the probability of occurrence of harm and the severity of that harm”, as set out in the document ICH Q9. But how are these concepts to be realized in practice?
To assist those tasked with undertaking microbiological risk assessments, the Pharmaceutical Microbiology Interest Group (Pharmig) ran a meeting in Ireland, taking place the day after the society's annual Irish conference (see: "Assessing pharmaceutical quality control in Ireland"). This took place at the Portmarnock Hotel, in the eponymous town, which is a few miles outside of Dublin.
Portmarnock Hotel  view from the golf course. May 2108.
Portmarnock Hotel, view from the golf course. May 2108.
The opening presentation was delivered by Nuala Calnan, who is a Senior Associate with Lachman Consultant Services, Inc. In this presentation the quality of risk assessments was discussed, with the opinion conveyed that many risk assessments are considered by regulators to be flawed. Here too many are reactive, being written after the event (whereas regulators prefer proactive risk assessments) and too many attempt to ameliorate the risks, rather than highlighting real problems.
The importance of risk assessment - a guide to the HACCP method.
The importance of risk assessment - a guide to the HACCP method.
This was followed by a presentation from Edel Fitzmaurice, who is a microbiologist and pharmaceutical industry consultant. This looked at the practical application of a risk management tool called Hazard Analysis and Critical Control Points (HACCP). The technique was first used in the food industry, but it can be readily applied to pharmaceuticals, especially looked at process flows and helping to eliminate stages where cross-contamination can occur. This systematic preventive approach can also aid microbiologists in determining when and where to take samples for analysis. The presentation was followed by a case study.
The next presentation as delivered by Tim Sandle, and it was looking at an alternative risk assessment tool called Failure Modes and Effects Analysis (FMEA), which comes from the engineering sector. This tool differs in that it is quantitative and relies on a risk scoring system. This highly structured, systematic techniques for failure analysis looks for 'failure modes'. Sandle demonstrated how the tool could be used to evaluate isolators (barrier systems designed to stop people interacting with clean environments through a mix of physical barriers and filtered air). This was followed by another practical exercise for the participants, looking at risk ranking different scenarios affecting pharmaceutical production.
The course delegates engage in a risk assessment exercise.
The course delegates engage in a risk assessment exercise.
The final presentation of the day came from David Keen, who is the Senior Global Microbiology Consultant at the disinfectant company Ecolab. This looked at how and when risk assessments can go wrong, especially where wither all of the facts are not known (and hence the wrong conclusions reached) or where sound science is not used from the outset, or where not all of the applicable experts are present during the execution of the risk assessment.
David Keen  presenting at the risk management meeting. May 2018.
David Keen, presenting at the risk management meeting. May 2018.
The meeting drew together the reasons why risk assessment is important to pharmaceutical manufacture and how it can be practically applied. A final take-home message was that such exercises should not be one-off activities; risk assessments need to be regularly reviewed and updated: it is only by remaining current that risks can be effectively managed.
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