We started our business activity with a quality concept from the very first day. Our Head of QA and we shared the experience of a retroactively established quality management concept at the Zentrallaboratorium Deutscher Apotheker – and from there we brought a quality vision to the new company. From the very first day, all processes were anchored in our QMS.
A critical reflection of the process, the rejection of the argument “we have always done it like this” together with a working atmosphere and a team spirit that fosters a no-blame culture, paired with steady efforts for improvement – only this combination generates real quality.
Regular internal audits and a systematic follow-up allow the identification of weak points, risks and errors. The QA unit’s independence and their ongoing training and communication with third parties guarantee that we keep moving forward.
Regular and intensive sponsor audits ensure that we recognise any blind spots and that we must and can face the latest trends and developments. The know-how of our diverse sponsors widens our horizons and helps to check and re-check our system – so we keep moving forward.
Pharmaceutical Quality by Design is normally associated with an understanding of the pharmaceutical product in combination with the process by which it is developed and manufactured. The general principle behind – knowing the risks is the first step to mitigate those risks – is applicable to all quality-oriented concepts.
Contract research in pharmaceutical industry means that tailored scientific solutions are to be developed – solutions that must satisfy the highest quality requirements. The challenge is to combine quality-assured standard working processes with new customised or even entirely newly developed processes, which means forward-looking planning of daily risk management.