Comprehensive systems and controls should be in place across the supply chain and development, considering ICH Q10, Q9 and Q8. But this is not enough. Q-Mindset and Q-Culture is the most important indicator of a company’s ability to deliver products with high quality. It’s about behavior – Not SOPs. Q is everyone’s accountability. Improvement is everyone’s responsibility. Everyone is accountable to make right decisions. Quality behavior in the...
It’s about Behavior – Not SOPs. Nevertheless comprehensive and smart systems should be established by standard operating procedures and quality controls shall be in place across the supply chain and development. Standard operating procedures tend to freeze a process as it is and not as it should be or as it is actually performed. Key in keeping Q-Systems improving all the time is to assess these procedures on a regular basis by independent...
The Quality-Organization is the competent partner to manage the supply chain, but not accountable for the quality of products and documents. There must be a clear distinction between QA as partner, QA as Q-System owner, QA as approver and QA as inspector across the supply chain similar to executive-, legislative- and judiciary power. And not to be forgotten enough resources to fulfil the tasks which is within the accountability of the managing...
Q-Excellence on top is considered as flawless execution or the 6-10 Sigma approach in pharmaceutical industry, which can only be achieved by behavior and leadership as strong basements. Clear and open communication and knowledge-, behavior-, engagement- and event transfer top down and bottom up. A balanced approach in setting the realistic strategy, developing trusting relationships with others, and consistently do the right thing based on...
Comprehensive systems and controls should be in place across the supply chain and development [more…]
Q-Excellence on top is considered as flawless execution or the 6-10 Sigma approach in pharmaceutical industry [more…]
"Quality is never an accident. It is always the result of intelligent effort" (John Ruskin)
