Already in 2015 and 2016, the FDA published draft guidance on the subject, which was generally not well received by pharmaceutical manufacturers. Not only the high costs of collecting all this information, but also the enormous workload that would arise from it were criticised. Finally, industry was called upon to submit quality data on a voluntary basis. The FDA has now announced that it has learned from the shortcomings of the original collection plan, but of course also from the quality data that have been submitted in the meantime and the feedback from pharmaceutical manufacturers.
What's new in 2022?
The FDA plans to offer manufacturers the opportunity to select one or more quality metrics from each area that are meaningful and allow opportunities for continuous improvement. The FDA states that compliance with current good manufacturing practice (cGMP) requirements is the "minimum standard" for ensuring safety and efficacy. Still, cGMP does not necessarily indicate whether a manufacturer is investing in improvement and seeking sustained compliance, which is the state of consistent control over manufacturing performance and quality.
The FDA has identified four areas with could deliver appropriate individual quality metrics for reporting:
The FDA is seeking feedback and comments on the new programme proposal. The deadline t for commenting is set to 9 June 2022.
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