Hardware Podcasts

257 - 21 CFR Part 4 Explained: CGMP Requirements for Combination Products

Let's Combinate · 5 Oct 2026 · 12m

What this episode covers

Subhi Saadeh, a consultant and auditor specializing in combination products, explains the CGMP requirements under 21 CFR Part 4 for products containing both drug and device elements. She details the scope of single-entity and co-packaged products, the baseline expectation of meeting all applicable regulations, and the two compliance paths: full integration or a streamlined approach. Saadeh outlines specific ISO 13485 sections required for drug-based systems and 21 CFR Part 211 sections for device-based systems, highlighting complexities like management review differences and reserve sample storage.

Most relevant to

companies scaling up

Topics

Mentioned

Products
Tylenol
Also
21 CFR Part 4, ISO 13485, QMSR, 21 CFR Part 211, ICH Q10

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