15.-17. September 2020
Europe's largest Pharma Congress of its kind took place on 12 and 13 April 2016 in the Swissotel Düsseldorf, Germany. Over the two days, more than 1,000 delegates attended the ten GMP/ FDA conferences organised. Associated with the Pharma Congress, the PharmaTechnica is the exhibition for pharmaceutical suppliers and service providers. This year, the exhibition space was extended and could thus welcome 90 exhibitors who presented their innovations and news with regard to pharmaceutical technology.
50 lectures, almost exclusively case studies from pharmaceutical companies such as Pfizer, Novartis, Boehringer Ingelheim and many more were discussed. Special attention was paid to the keynotes at the beginning of each conference day. We already reported about the keynote on the first day in our GMP News entitled "EU GMP Annex 1 Revision 2016 - what does the pharmaceutical industry expect?"
On the second day, Dr Andreas König, Senior Vice President at Aenova opened the Pharma Congress with a keynote. Aenova is a fast-growing pharmaceutical company in the area of contract manufacturing. Within a few years, the number of employees rose to 4,400. Today, the company is one of Europe's largest contract manufacturers.
Quality Metrics are a hotly-debated topic. At the end of July 2015, the U.S. FDA released a Draft Guide entitled "Request for Quality Metrics - Guidance for Industry". In the document, the FDA describes which indicators will have to be submitted regularly in future by pharmaceutical and API companies to the FDA. Currently, the FDA Guideline is being intensively discussed because the FDA wants to use the data as part of the planning for future inspections. The idea is to identify at an early stage problems related to manufacturing and quality assurance. Using statistical tools, trends (like for example in complaints or in OOS results) should be detected. Companies with stable processes (keyword "CPK value") should be "rewarded" and their inspection cycle should be longer than for companies with less stable processes and more process deviations.
In his case study, Dr König showed that already today the Key Performance Indicators (Quality Metrics) are measured. On the corporate level, the following "Core KPIs" have been defined:
The trending of KPIs is the basis for discussing improvements. Furthermore, the absolute KPI values are compared to identify "Best Practice". Finally, the KPI values are used to formulate new objectives for "Quality Targets".
Dr König underlined that it is necessary to consider the KPIs in a multidimensional way at different levels of the company. Data can thus be aggregated at the different levels. At the Site Quality Boards' level, all data are systematically collected. Essential statements are then concretised in a second step for the Quality Leadership Team and eventually summarised for Aenova's Quality Board in the form of charts and metrics for decision-making. In this context, it is important to have a feedback process too, to draw appropriate conclusions from the values and to take measures.
Determining KPIs/Quality Metrics helps improving transparency and implementing improvement measures as well as defining quality targets for continuous improvement. Here, it is important to note that there may be a risk of pseudo-transparency which doesn't reflect the reality. KPIs will never ever be able to replace the knowledge of the persons involved in the process.
Controversially, FDA's approach was also discussed according to which Quality Metrics should be statistically prepared within the Agency. Dr König pointed out that currently the data are used for internal purposes only. Without knowing the concrete procedures and process changes, there might be a risk that trends are identified which in reality aren't or have been wrongly interpreted. There also may be a risk that measures are taken to optimise metrics - with no real benefit for the product or the process. Currently, the FDA is in discussion with the pharmaceutical associations about the proposed Guideline. An essential point of the discussion is to ensure that the submission of KPIs to the FDA doesn't bring the disadvantages mentioned.