Does your GDP Quality Management System identify risks to patient and product safety?
If not, why not?
Need help? Then read on.
The EU GDP Guidelines mentions risk and risk identification for the first time ever;
1.5. Quality risk management
Quality risk management is a systematic process for the assessment, control, communication and review of risks to the quality of medicinal products. It can be applied both proactively and retrospectively.
Quality risk management should ensure that the evaluation of the risk to quality is based on scientific knowledge, experience with the process and ultimately links to the protection of the patient. The level of effort, formality and documentation of the process should be commensurate with the level of risk.
Examples of the processes and applications of quality risk management can be found in guideline Q9 of the International Conference on Harmonisation (‘ICH’).
Of course you do, and you carry them out automatically.
Yet the medicines we handle are often not assessed in the same way.
We tend to apply very few risk assessments to products we, or our family, consume.
So… How can you start better managing your GDP risk assessments?
If we were an ordinary business we’d say “We know how to manage risk. Recruit us today.”
But… as we are rolling in a new paradigm, we say…
How do you start on your risk assessment process?
Firstly, define the task
So what risk assessment tools could you use?
A simple spreadsheet method works for many.
Transportation of product
Actions to mitigate risk:
Audit, monitor temperatures with appropriate and calibrated equipment, training, robust SOPs
A consistent and frequent review protocol is advised, this is not a one-off process, and should be revisited;
Seasonally at first (minimum Winter and Summer) for temperatures
At any point that processes or business model changes – can be “quick and dirty”
Bear in mind that what may seem a small change in one part of the business could have a knock on effect to other areas
What other tools are useful?
We like flow charts and process mapping, as well as FMEA (Failure mode Effects Analysis), but a fishbone diagram (Ishikawa diagram) can also be useful.
HACCP – Hazard Analysis and Critical Control Points – is used frequently in the manufacturing industry.
Through this process you establish where your CCPS (Critical control points) are, then monitor them for compliance to your regulatory requirements.
From this you can identify where your hazards/risks are present and look to mitigate.
When something fails you use CAPA, and generate a report on what corrective action you took to mitigate against further recurrence of deviation.
By reviewing your records, and being on a process of continual improvement you will come to know your risks and how to avoid them.
It isn’t possible to mitigate everything, but you need to consider this and document it, to show you have at least consider risk and implications.
One risk assessment reference that may be of value;
Of course, there may be occasions where you don’t have the skills or experience to carry out risk assessments, or you may want a third party GDP audit or GDP risk assessment audit.
If so, please contact us for a free, no obligation chat.
Welcome to a new Paradigm!
13 Mar 2017
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