Do we have a problem with Quality within the pharmaceutical industry?

One could think that high quality is a significant attribute within the pharma and medical device industry but is that really true?

I recently read an article in the PDA Letter1 that 64% of the drug shortages in the USA were caused by quality issues. I also saw an interesting benchmark in Pharmaceutical Engineering2 (ISPE) where Pharma was compared to Automotive, Aerospace, Computer and Consumer Packaged Goods industries in several areas that was honestly quite depressing, i.e. “First-pass yield – zero defects” in Pharma was 60% compared to 90-99% in all other sectors except Aerospace (70-90%).

I do not have a good answer why this is the case but I strongly believe that a “better” attitude towards GMP and quality is needed. I still see organizations where QA and Production almost fight each other – Production blames QA for slowing them down and putting unrealistic demands on them and QA blame Production for not documenting properly or doing good enough investigations. I also do see good examples of course and I will spend some time in a future Blog post to discuss that.

What do you think about the Quality Mindset within you own organization? How would you grade it on this scale?



Anna Lundén

Anna Lundén
Training manager and part owner
Key2Compliance AB

1 PDA Letter, Nov/Dec 2014, page 41-42
2 Pharmaceutical Engineering, Sep/Oct 2014, page 42