Since the FDA began releasing its annual Summary of Inspection Observations report in 2006, the number one cited observation in FDA 483s every year has been quality control unit failures. The second most cited FDA observation, failure to thoroughly review unexplained discrepancies/meet expectations, is also the most frequently cited observation by Europe’s Medicines and Healthcare products Regulatory Agency (MHRA).
Joanna Gallant, an independent consultant specializing in training and performance in GMP environments, says these observations, as well as the remaining top 10 citings, indicate a need for more robust processes in the pharmaceutical industry. However, in order to ensure your processes are effective, Gallant says you must also be sure your people have the skills and knowledge necessary to successfully implement them. She explains, “Our people are the biggest risk to our processes. “ In order to measure your GMP compliance, as well as the effectiveness of your processes and people, Gallant suggests asking yourself the following five questions.