In the pharmaceutical industry, quality is one of the foremost considerations. Technological evolution has enabled new ways of delivering quality, which go beyond compliance. In fact, a proactive approach will help create the greatest value for the patient and for the pharma company. For this, a quality mindset must be achieved. This diagram represents how, through an explanation of its elements as mentioned below. You can apply this in your organisation as a building block for the quality mindset.
The triangle:
The process of making medicine is to create value for the patient. The patient’s voice is expressed by the Quality Target Product Profile as defined in the ICH.Q8. To deliver value to the patient, we design, manufacture, and distribute medicine. The medicine is made by a process. The process takes place in facilities with equipment, utilities and material, all of which are managed by SOPs. This diagram represents how the use of Critical Design Elements (CDEs), as defined in the ISPE Baseline guide 5 Vol 2.0, support the quality by design approach of the ICHQ8.
Feel free to download this diagram to communicate to your team, client, or manager. Contact us if you want to know more about the process.
The little guy:
This is based on many studies and more directly translated from the ISPE Culture Excellence Report of 2017 (for members only). We want everyone working in healthcare to consider quality as a devotion. This means, quality is built into everything we do because it is the right thing for our patients, our colleagues, and our organisation. The way to achieve that is to make people accountable.
You can find more in the ISPE document or you may contact us to discuss the different dimensions of the quality culture.
MINDSET SHIFTS
Observer:
I observe quality in my area. It is interesting, but it doesn’t have anything to do with me. I do what’s asked and follow the simple instructions.
Reactive orientation:
I spend most of my time responding to and fixing problems that arise to keep up with production schedules.
Ownership:
I am responsible for quality in my area. I don’t assume that an error will be caught by someone else.
Proactive Orientation:
I spend most of my time identifying issues proactively and intervening to minimize any potential negative impact on quality and compliance.
Feedback from the 2021 ISPE Global Pharmaceutical Regulatory Summit
On 16 June 2021, I had the pleasure to assist the ISPE Global Pharmaceutical Regulatory Summit, Regulatory and Industry Panel Discussion. The 2 main topics were the most fundamental ones – Quality Risk Management and Quality Vs Compliance or Quality mindset. The panel was a mix of Regulatory and Industrial representatives from MHRA, FDA, EMA, AbbVie, and Cipla Ltd. among others.
Covid 19 has brought the world to a stop. It is also the most impacting factor in the pharmaceutical world. The Situation has exacerbated some problems (cross-contamination, late delivery,…) and elevated others (new technologies, speed of manufacturing).
Listening to the panel you can appreciate how the principles of QRM and Pharmaceutical Quality Management were key elements in the mindset of the successful one.
During the discussion, you quickly understand that there is no playbook to cope with the disruption and challenges that the industry faced at the beginning of 2020 and what was needed to keep medicine supplied to patients.
Key operators and key analysts were ring fences to protect them from the pandemic because their role in manufacturing or product releasing was absolutely critical. This is an example of Quality Risk Management. Identifying the threat, analysing the risk and applying mitigation action, reviewing the situation and the impact of the new organisation on the established communication channel is crucial in any battlefield when transparency will allow you to make decisions.
Discussion between the MHRA/FDA/EMA regulator could be summarised as: When you dissociate the quality mindset from regulatory compliance, you will be able to communicate quality issues to the regulator, which will then create a trust relationship benefiting the patient. This will assure that risks are not downplayed within the organisation, demonstrating a maturity in adopting a quality mindset and embracing the intent of QRM.
Carmelo Rosa (FDA) highlighted that it takes a lot of effort to have a global quality system. And it is obvious for the regulator that companies are still competing internally for their portfolio, ultimately affecting product quality. The catalyst to overcome those issues are linked to quality mindset and knowledge management.
To answer the question, “How can we share our mistakes openly in the industry?”, an example was given: The loss of data related to quality that was stored in the cloud.
The company quickly assessed the situation and called the regulator to discuss the potential quality risk and the obvious non-compliance. Demonstrating that quality and compliance go hand-in-hand but a compliance risk is not necessarily a quality risk, likewise being compliant is not sufficient to make a quality product.
The discussion highlighted that digitalisation is inevitable (Benjamin Noyen, TGA) and is a way to eliminate human error. When you think of it from a risk management perspective, it is obvious that engineering controls are the most robust choice for eliminating or mitigating the risk. However, digitalisation introduces new risks linked to data integrity.
Going back to our previous blog on the factors leading to some data integrity (which itself would lead to a product quality risk), the following illustration could be applied in a larger scope.
The debate then challenged the regulators on their view of machine learning to help triaging where resources should be allocated and David Churchward (MHRA) explained that the regulators are open-minded about it, while recognising it is not only about the algorithm but also the data set chosen to run it. Making sure there is no bias in that data set is critical, e.g. taking a picture of the north face of the building to establish how much the building is exposed to the sun. If you want to understand this comment, read our blog about digitalisation.
At No deviation, we partner with you to help you build the quality in your product. Reach out to us to know how we can help you achieve, retain, and regain cGMP compliance.
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