Who is ultimately responsible for quality/the quality management system at a life science company: (A) all personnel working for the company, (B) the quality assurance department, or (C) company management (including top executives)? Note your answer somewhere before reading this article.
#MeToo and Time’s Up are spotlighting illegal, unethical, improper, and undesirable behaviors. Illegal, unethical, improper, and undesirable behavior exists in the GMP world, too, and we’ve been warned as well.
I had given a good manufacturing practice (GMP) refresher session in a company whose mantra was efficiency and speed. After the session, a manufacturing operator talked to me about employees’ frustration with the situation, saying, "Why don't people understand that if we focus on doing things right, efficiency will come?"
We need to teach people how to think again. Then, we need to encourage them to think on a day-to-day basis so that they’re comfortable with it when a problem arises that requires out-of-the-box, beyond-the-SOP thinking.
In FDA-regulated industries, root cause analysis (RCA) is perhaps the most frequently used tool for identifying the source of a good manufacturing practice (GMP) deviation and determining an appropriate corrective and preventive action (CAPA). Yet, inadequate RCA is also one of the most common citations found in observations issued by FDA and other international regulatory bodies.
With all the data integrity issues highlighted in regulatory agency inspections over the last several years, it seems very few people are familiar with the court case that set the legal precedent for data integrity standards. This is largely the reason why we see so many data integrity issues today.