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Former FDA compliance official offers advice to biotech startups on how to avoid CMC and GMP complete responses.
Performance-Based Conditions Could Ease Post-Approval Changes For Process Analytical Technologies, Experts Say
Pharmaceutical industry officials are promoting the idea of “marrying” the concepts of performance-based approaches and process analytical technology in the draft ICH Q12 guideline. Embedding this idea in ICH Q12 would give industry more flexibility in managing post-approval changes and aligns with the guideline’s concept of lifecycle improvement.
Latest From Manufacturing
An upcoming PDA technical report is expected to build on the concepts of an earlier report on laboratory systems and propose a risk-based approach for protecting data integrity using a nine-box grid for assessing data integrity risks.
Warning letter stemming from global nitrosamine investigation raises new concerns about Indian manufacturer.
Firm should have addressed complaints of gritty topicals and compromised container/closures, and its own findings about overheated creams, the US FDA says.
Risk-based approaches are needed to handle the flexibility, subjectivity and unpredictability that comes with quality reviews of these new technologies, Pfizer official says.
The detection of cancer-causing impurities in drugs with well-established safety profiles may force regulators across the globe to revise their approach for evaluating quality.
Industry groups PDA and ISPE have banded together to produce a guide to help pharmaceutical manufacturers get a better handle on their deviations through choosing the right root cause analysis method and human factors studies.
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