{ “@context”: “https://schema.org”, “@type”: “FAQPage”, “name”: “FDA CMC requirements: data integrity, impurities, method validation, and stability”, “mainEntity”: [ { “@type”: “Question”, “name”: “What are the FDA CMC requirements for a new drug application?”, “acceptedAnswer”: { “@type”: “Answer”, “text”: “FDA CMC requirements cover four linked areas: data integrity under 21 CFR 211 and 21 CFR 11, impurity control under the ICH Q3 series, analytical method validation under ICH Q2(R2), and stability under ICH Q1 and 21 CFR 211.166. Reviewers assess whether the evidence chain is closed and whether limits carry product-specific scientific justification, not simply whether each study was completed.” } }, { “@type”: “Question”, “name”: “How many commercial-scale batches does…